REVIEW_PANEL|MEDICALSPECIALTY|PRODUCTCODE|DEVICENAME|DEVICECLASS|UNCLASSIFIED_REASON|GMPEXEMPTFLAG|THIRDPARTYFLAG|REVIEWCODE|REGULATIONNUMBER|SUBMISSION_TYPE_ID|DEFINITION|PHYSICALSTATE|TECHNICALMETHOD|TARGETAREA|Implant_Flag|Life_Sustain_support_flag
AN|AN|BRW|Protector, Dental|1||N|N||868.5820|4|||||N|N
AN|AN|BRX|Stool, Anesthesia|1||N|N||868.6700|4|||||N|N
AN|AN|BRY|Cabinet, Table And Tray, Anesthesia|1||N|N||868.6100|4|||||N|N
AN|AN|BSE|Analyzer, Gas, Helium, Gaseous-Phase|2||N|P||868.1640|1|||||N|N
AN|AN|BSF|Absorber, Carbon-Dioxide|1||N|N||868.5310|4|||||N|N
AN|AN|BSI|Algesimeter, Powered|2||N|P||868.1040|4|||||N|N
AN|AN|BSJ|Mask, Gas, Anesthetic|1||N|N||868.5550|4|||||N|N
AN|AN|BSK|Cuff, Tracheal Tube, Inflatable|2||N|P||868.5750|1|||||N|Y
AN|AN|BSN|Filter, Conduction, Anesthetic|2||N|P||868.5130|1|||||N|N
AN|AN|BSO|Catheter, Conduction, Anesthetic|2||N|P||868.5120|1|||||N|N
AN|AN|BSP|Needle, Conduction, Anesthetic (W/Wo Introducer)|2||N|P||868.5150|1|||||N|N
AN|AN|BSR|Stylet, Tracheal Tube|1||N|N||868.5790|4|||||N|N
AN|AN|BSY|Catheters, Suction, Tracheobronchial|1||N|N||868.6810|4|||||N|N
AN|AN|BSZ|Gas-Machine, Anesthesia|2||N|N||868.5160|1|||||N|Y
AN|AN|BTB|Hook, Ether|1||Y|N||868.5420|4|||||N|N
AN|AN|BTC|Bag, Reservoir|1||N|N||868.5320|4|||||N|N
AN|AN|BTI|Compressor, Air, Portable|2||N|P||868.6250|4|||||N|N
AN|AN|BTK|Strap, Head, Gas Mask|1||N|N||868.5560|4|||||N|N
AN|AN|BTL|Ventilator, Emergency, Powered (Resuscitator)|2||N|P||868.5925|1|||||N|Y
AN|AN|BTM|Ventilator, Emergency, Manual (Resuscitator)|2||N|P||868.5915|1|||||N|Y
AN|AN|BTO|Tube, Tracheostomy (W/Wo Connector)|2||N|P||868.5800|1|||||N|Y
AN|AN|BTP|Dropper, Ether|1||Y|N||868.5420|4|||||N|N
AN|AN|BTQ|Airway, Nasopharyngeal|1||N|N||868.5100|4|||||N|N
AN|AN|BTR|Tube, Tracheal (W/Wo Connector)|2||N|N||868.5730|1|||||N|Y
AN|AN|BTS|Tube, Bronchial (W/Wo Connector)|2||N|N||868.5720|1|||||N|Y
AN|AN|BTT|Humidifier, Respiratory Gas, (Direct Patient Interface)|2||N|P||868.5450|1|||||N|N
AN|AN|BTY|Calculator, Predicted Values, Pulmonary Function|2||N|P||868.1890|1|||||N|N
AN|AN|BWB|Forceps, Tube Introduction|1||N|N||868.5780|4|||||N|N
AN|AN|BWC|Needle, Emergency Airway|2||N|P||868.5090|1|||||N|Y
AN|AN|BWF|Spirometer, Therapeutic (Incentive)|2||N|P||868.5690|1|||||N|N
AN|AN|BWL|Apparatus, Electronanesthesia|3||N|N||868.5400|2|Call for PMAs 12/26/96 (61 FR 50706 (9/27/96))||||N|N
AN|AN|BXA|Analyzer, Gas, Water Vapor, Gaseous-Phase|1||N|N||868.1975|4|||||N|N
AN|AN|BXH|Gauge, Gas Pressure, Cylinder/Pipeline|1||N|N||868.2610|4|||||N|N
AN|AN|BXJ|Clip, Nose|1||Y|N||868.6225|4|||||N|N
AN|AN|BXK|Gas, Calibration (Specified Concentration)|1||N|N||868.6400|4|||||N|N
AN|AN|BXL|Algesimeter, Manual|1||Y|N||868.1030|4|||||N|N
AN|AN|BXM|Stimulator, Nerve, Ac-Powered|2||N|P||868.2775|1|||||N|N
AN|AN|BXN|Stimulator, Nerve, Battery-Powered|2||N|P||868.2775|1|||||N|N
AN|AN|BXO|Transducer, Gas Pressure|1||N|N||868.2900|4|||||N|N
AN|AN|BXP|Transducer, Gas Flow|1||N|N||868.2885|4|||||N|N
AN|AN|BXQ|Rhinoanemometer (Measurement Of Nasal Decongestion)|2||N|P||868.1800|1|||||N|N
AN|AN|BXR|Meter, Airway Pressure (Inspiratory Force)|2||N|P||868.1780|1|||||N|N
AN|AN|BXW|Calibrator, Volume, Gas|1||N|N||868.1870|4|||||N|N
AN|AN|BXX|Calibrator, Pressure, Gas|1||N|N||868.2620|4|||||N|N
AN|AN|BXY|Flowmeter, Calibration, Gas|1||N|N||868.2350|4|||||N|N
AN|AN|BYD|Condenser, Heat And Moisture (Artificial Nose)|1||N|N||868.5375|4|||||N|N
AN|AN|BYE|Attachment, Breathing, Positive End Expiratory Pressure|2||N|P||868.5965|1|||||N|Y
AN|AN|BYF|Mask, Oxygen, Low Concentration, Venturi|1||N|N||868.5600|4|||||N|N
AN|AN|BYG|Mask, Oxygen|1||N|N||868.5580|4|||||N|N
AN|AN|BYH|Drain, Tee (Water Trap)|1||N|N||868.5995|4|||||N|N
AN|AN|BYI|Percussor, Powered-Electric|2||N|P||868.5665|1|||||N|N
AN|AN|BYJ|Unit, Liquid-Oxygen, Portable|2||N|P||868.5655|1|||||N|N
AN|AN|BYK|Tent, Oxygen, Electrically Powered|2||N|P||868.5710|1|||||N|Y
AN|AN|BYL|Tent, Oxygen|1||N|N||868.5700|4|||||N|N
AN|AN|BYM|Tube, Thorpe, Uncompensated|1||N|N||868.2320|4|||||N|N
AN|AN|BYN|Chair, Posture, For Cardiac And Pulmonary Treatment|1||N|N||868.5365|4|||||N|N
AN|AN|BYO|Bottle, Blow|1||Y|N||868.5220|4|||||N|N
AN|AN|BYP|Mouthpiece, Breathing|1||N|N||868.5620|4|||||N|N
AN|AN|BYR|Transducer, Gas Pressure, Differential|1||N|N||868.2875|4|||||N|N
AN|AN|BYS|Membrane, Lung, (For Long-Term Respiratory Support)|3||N|N||868.5610|1|||||N|Y
AN|AN|BYT|Ventilator, External Body, Negative Pressure, Adult (Cuirass)|2||N|P||868.5935|1|||||N|Y
AN|AN|BYW|Device, Rebreathing|1||N|N||868.5675|4|||||N|N
AN|AN|BYX|Tubing, Pressure And Accessories|1||N|N||868.5860|4|||||N|N
AN|AN|BZA|Connector, Airway (Extension)|1||N|N||868.5810|4|||||N|N
AN|AN|BZB|Catheter, Nasal, Oxygen|1||N|N||868.5350|4|||||N|N
AN|AN|BZC|Calculator, Pulmonary Function Data|2||N|P||868.1880|1|||||N|N
AN|AN|BZD|Ventilator, Non-Continuous (Respirator)|2||N|N||868.5905|1|||||N|N
AN|AN|BZE|Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer|2||N|P||868.5270|1|||||N|N
AN|AN|BZG|Spirometer, Diagnostic|2||N|P||868.1840|1|||||N|N
AN|AN|BZH|Meter, Peak Flow, Spirometry|2||N|P||868.1860|1|||||N|N
AN|AN|BZK|Spirometer, Monitoring (W/Wo Alarm)|2||N|P||868.1850|1|||||N|N
AN|AN|BZL|Computer, Oxygen-Uptake|2||N|P||868.1730|1|||||N|N
AN|AN|BZM|Calculator, Pulmonary Function Interpretator (Diagnostic)|2||N|P||868.1900|1|||||N|N
AN|AN|BZN|Cart, Emergency, Cardiopulmonary (Excluding Equipment)|1||Y|N||868.6175|4|||||N|N
AN|AN|BZO|Set, Tubing And Support, Ventilator (W Harness)|1||N|N||868.5975|4|||||N|N
AN|AN|BZQ|Monitor, Breathing Frequency|2||N|Y||868.2375|1|||||N|N
AN|AN|BZR|Mixer, Breathing Gases, Anesthesia Inhalation|2||N|P||868.5330|1|||||N|Y
AN|AN|BZS|Stethoscope Head|1||N|N||868.1930|4|||||N|N
AN|AN|BZT|Stethoscope, Esophageal, With Electrical Conductors|2||N|P||868.1920|1|||||N|N
AN|AN|BZW|Stethoscope, Esophageal|1||N|N||868.1910|4|||||N|N
AN|AN|CAC|Apparatus, Autotransfusion|2||N|N||868.5830|1|||||N|Y
AN|AN|CAD|Vaporizer, Anesthesia, Non-Heated|2||N|P||868.5880|1|||||N|N
AN|AN|CAE|Airway, Oropharyngeal, Anesthesiology|1||N|N||868.5110|4|||||N|N
AN|AN|CAF|Nebulizer (Direct Patient Interface)|2||N|Y|M|868.5630|1|||||N|N
AN|AN|CAG|Circulator, Breathing-Circuit|2||N|P||868.5250|1|||||N|Y
AN|AN|CAI|Circuit, Breathing (W Connector, Adaptor, Y Piece)|1||N|N||868.5240|4|||||N|N
AN|AN|CAL|Laryngoscope, Non-Rigid|1||N|N||868.5530|4|||||N|N
AN|AN|CAM|Yoke Assembly, Medical Gas|1||N|N||868.6885|4|||||N|N
AN|AN|CAN|Regulator, Pressure, Gas Cylinder|1||N|N||868.2700|4|||||N|N
AN|AN|CAO|Airway, Esophageal (Obturator)|2||N|N||868.5650|1|||||N|Y
AN|AN|CAP|Monitor, Airway Pressure (Includes Gauge And/Or Alarm)|2||N|P||868.2600|1|||||N|N
AN|AN|CAT|Cannula, Nasal, Oxygen|1||N|N||868.5340|4|||||N|N
AN|AN|CAW|Generator, Oxygen, Portable|2||N|Y||868.5440|1|||||N|N
AN|AN|CAX|Flowmeter, Tube, Thorpe, Back-Pressure Compensated|1||N|N||868.2340|4|||||N|N
AN|AN|CAZ|Anesthesia Conduction Kit|2||N|P||868.5140|1|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
AN|AN|CBA|Monitor, Air Embolism, Ultrasonic|2||N|P||868.2025|1|||||N|N
AN|AN|CBF|Chamber, Hyperbaric|2||N|Y||868.5470|1|||||N|Y
AN|AN|CBG|Spreader, Cuff|1||Y|N||868.5760|4|||||N|N
AN|AN|CBH|Device, Fixation, Tracheal Tube|1||N|N||868.5770|4|||||N|N
AN|AN|CBI|Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)|2||N|N||868.5740|1|||||N|Y
AN|AN|CBK|Ventilator, Continuous, Facility Use|2||N|N||868.5895|1|||||N|Y
AN|AN|CBL|Absorbent, Carbon-Dioxide|1||N|N||868.5300|4|||||N|N
AN|AN|CBN|Apparatus, Gas-Scavenging|2||N|P||868.5430|1|||||N|N
AN|AN|CBO|Attachment, Intermitant Mandatory Ventilation (Imv)|2||N|N||868.5955|1|||||N|Y
AN|AN|CBP|Valve, Non-Rebreathing|2||N|P||868.5870|1|||||N|Y
AN|AN|CBQ|Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)|2||N|P||868.1500|1|||||N|N
AN|AN|CBR|Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)|2||N|P||868.1700|1|||||N|N
AN|AN|CBS|Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)|2||N|P||868.1620|1|||||N|N
AN|AN|CBT|Arterial Blood Sampling Kit|1||N|N||868.1100|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
AN|AN|CBZ|Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling|2||N|P||868.1170|1|||||N|N
AN|AN|CCC|Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling|2||N|P||868.1150|1|||||N|N
AN|AN|CCE|Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling|2||N|P||868.1200|1|||||N|N
AN|AN|CCI|Analyzer, Gas, Nitrogen, Gaseous-Phase|2||N|P||868.1690|1|||||N|N
AN|AN|CCJ|Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase|2||N|P||868.1430|1|||||N|N
AN|AN|CCK|Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase|2||N|P||868.1400|1|||||N|N
AN|AN|CCL|Analyzer, Gas, Oxygen, Gaseous-Phase|2||N|P||868.1720|1|||||N|N
AN|AN|CCM|Plethysmograph, Pressure|2||N|P||868.1750|1|||||N|N
AN|AN|CCN|Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge|1||N|N||868.2300|4|||||N|N
AN|AN|CCO|Bed, Rocking, Breathing Assist|2||N|P||868.5180|4|||||N|Y
AN|AN|CCQ|Nebulizer, Medicinal, Non-Ventilatory (Atomizer)|1||N|N||868.5640|4|||||N|N
AN|AN|CCT|Applicator (Laryngo-Tracheal), Topical Anesthesia|2||N|P||868.5170|1|||||N|N
AN|AN|CCW|Laryngoscope, Rigid|1||N|N||868.5540|4|||||N|N
AN|AN|CCX|Support, Patient Position|1||N|N||868.6820|4|||||N|N
AN|AN|EPE|Brush, Cleaning, Tracheal Tube|1||Y|N||868.5795|4|||||N|N
AN|AN|FLS|Monitor, Apnea, Facility Use|2||N|N||868.2377|1|||||N|Y
AN|AN|FNC|Tent, Pediatric Aerosol|2||N|P||868.5710|1|||||N|N
AN|AN|FOG|Hood, Oxygen, Infant|1||N|N||868.5700|4|||||N|N
AN|AN|JAX|Pneumotachometer|2||N|P||868.2550|4|||||N|N
AN|AN|JAY|Support, Breathing Tube|1||N|N||868.5280|4|||||N|N
AN|AN|JED|Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling|3||N|N||868.1120|2|A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to an indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976. Any other indwelling blood oxyhemoglobin concentration analyzer shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.||||N|N
AN|AN|JEF|Analyzer, Gas, Neon, Gaseous-Phase|2||N|P||868.1670|1|||||N|N
AN|AN|JEG|Analyzer, Gas, Argon, Gaseous-Phase|2||N|P||868.1075|1|||||N|N
AN|AN|JEH|Plethysmograph, Volume|2||N|P||868.1760|1|||||N|N
AN|AN|JEZ|Monitor, Lung Water Measurement|3||N|N||868.2450|2|||||N|N
AN|AN|JFE|Valve, Switching (Ploss)|1||Y|N||868.1965|4|||||N|N
AN|AN|JOH|Tube Tracheostomy And Tube Cuff|2||N|P||868.5800|1|||||N|Y
AN|AN|KFZ|Humidifier, Non-Direct Patient Interface (Home-Use)|1||N|N||868.5460|4|||||N|N
AN|AN|KGB|Mask, Oxygen, Non-Rebreathing|1||N|N||868.5570|4|||||N|N
AN|AN|KGK|Gas, Collecting Vessel|1||N|N||868.1575|4|||||N|N
AN|AN|KHA|Mask, Scavenging|1||N|N||868.5590|4|||||N|N
AN|AN|KLK|Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia|2||N|P||868.2500|4|||||N|N
AN|AN|KOI|Stimulator, Nerve, Peripheral, Electric|2||N|P||868.2775|1|||||N|N
AN|AN|LKD|Monitor, Carbon-Dioxide, Cutaneous|2||N|N||868.2480|1|||||N|N
AN|AN|LNZ|Changer, Tube, Endotracheal|2||N|P||868.5730|1|||||N|N
AN|AN|LPP|Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia|2||N|N||868.2500|4|||||N|N
AN|AN|MIA|Needle, Spinal, Short Term|2||N|P||868.5150|1|||||N|N
AN|AN|MNR|Ventilatory Effort Recorder|2||N|P||868.2375|1|||||N|N
AN|AN|MNS|Ventilator, Continuous, Non-Life-Supporting|2||N|N||868.5895|1|||||N|N
AN|AN|MNT|Ventilator, Continuous, Minimal Ventilatory Support,Facility Use|2||N|N||868.5895|1|||||N|Y
AN|AN|MOD|Accessory To Continuous Ventilator (Respirator)|2||N|P||868.5895|1|||||N|N
AN|AN|MRN|Apparatus, Nitric Oxide Delivery|2||N|N||868.5165|1|||||N|Y
AN|AN|MRO|Apparatus, Nitric Oxide, Backup Delivery|2||N|N||868.5165|1|||||N|Y
AN|AN|MRP|Analyzer, Nitric Oxide|2||N|N||868.2380|1|||||N|Y
AN|AN|MRQ|Analyzer, Nitrogen Dioxide|2||N|P||868.2385|4|||||N|Y
AN|AN|MZT|Device,Heimlich Maneuver Assist|2||N|N||868.5115|4|||||N|Y
AN|AN|NFB|Conserver, Oxygen|2||N|Y||868.5905|1|||||N|N
AN|AN|NHJ|Device, Positive Pressure Breathing, Intermittent|2||N|N||868.5905|1|||||N|N
AN|AN|NHK|Resuscitator,Manual,Non Self-Inflating|2||N|N||868.5905|1|A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of compressed breathing gas is required to inflate the bag.||||N|Y
AN|AN|NHO|Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)|2||N|P||868.1500|1|A desflurane gas analyzer is a device intended to measure the concentration of desflurane anesthetic in a gas mixture.||||N|N
AN|AN|NHP|Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)|2||N|P||868.1500|1|A sevoflurane gas analyzer is a device intended to measure the concentration of sevoflurane anesthetic in a gas mixture||||N|N
AN|AN|NHQ|Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)|2||N|P||868.1500|1|A isoflurane gas analyzer is a device intended to measure the concentration of isoflurane anesthetic in a gas mixture||||N|N
AN|AN|NMA|Tube, Tracheal, Reprocessed|2||N|N||868.5730|1|||||N|Y
AN|AN|NMC|Mask, Ventilator, Non-Continuous, Reprocessed|2||N|N||868.5905|1|Reprocessed mask for use with a non-continuous ventilator (CPAP, BiLevel pressure).||||N|N
AN|AN|NMR|Needle, Spinal, Short Term, Reprocessed|2||N|N||868.5150|1|||||N|N
AN|AN|NNH|Needle, Conduction, Anesthesia, Reprocessed|2||N|N||868.5150|1|A reprocessed needle is a device used to inject local anesthesia into a patient to provide regional anesthesia.  This is the same as "BSP."||||N|N
AN|AN|NOU|Continuous, Ventilator, Home Use|2||N|N||868.5895|1|This product code was needed for the home use indication.  CBK is not a tracked device and NOU is a tracked device.||||N|Y
AN|AN|NPF|Monitor, Apnea, Home Use|2||N|N||868.2377|1|Same as the identification for product code FLS, just add home use||||N|Y
AN|AN|NQY|Ventilator, Continuous, Minimal Ventilatory Support, Home Use|2||N|N||868.5895|1|This continuous ventilator, which operates using a fixed or passive exhaust port, is intended to treat patients with respiratory failure in the home.||||N|Y
AN|AN|NVO|Spacer, Direct Patient Interface|2||N|N||868.5630|1|Spacers are devices that are used with nebulizers and metered dose inhalers that are comprised of a reservior into which an aerosol medication is dispensed.  A spacer uses an open mouthpiece.  Spacers are intended to minimize delivery of large aerosolized particles.|Spacers are frequently made of plastic, and can be tube shapped.|By holding drugs after aerosolization, spacers are intended to minimize delivery of large aerosolized particles, which would otherwise deposit in the mouth.|Spacers contact the mouth.  The drug they are holding is intended for the lower airways|N|N
AN|AN|NVP|Holding Chambers, Direct Patient Interface|2||N|N||868.5630|1|Holding chambers are devices that are used with nebulizers and metered dose inhalers and are comprised of a reservoir into which an aerosol medication is dispensed. A holding chamber uses a valved mouthpiece through which the patient inhales the dispensed medication.  Holding chambers are intended to minimize delivery of large aerosolized particles|Holding Chambers are frequently made of plastic, and can be tube shaped.|By holding drugs after aerosolization, holding chambers are intended to minimize delivery of large aerosolized particles which would otherwise depisit in the mouth, throat, or upper airway|Holding Chambers contact the mouth.  The drug they are holding is intended for the lower airways|N|N
AN|AN|NXA|Kit, Tracheotomy Care|2||N|P||868.5800|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
AN|AN|OBN|Humidifier, Respiratory, Mask (Direct Patient Interface)|2||N|N||868.5450|1|Intended to moderate blood pressure in hypertensive patients when they are exposed to the cold. The mask attenuates (moderates) the physiological response, increases in blood pressure, associated with cold exposure, by warming the inhaled air during cold exposure for individuals with hypertension, medicated or non-medicated.|A simple mask that is placed over the patient's nose and mouth, and held in place with an elastic band around the back of the head.|Non-invasive heat-exchange device|Patient's nose/mouth area.|N|N
AN|AN|OFO|Airway Suction Kit|1||N|N||868.6810|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
AN|AN|OFP|Anesthesia Breathing Circuit Kit (Adult & Pediatric)|1||N|N||868.5240|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
AN|AN|OFQ|Anesthesia Kit|2||N|N||868.5120|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
AN|AN|OFR|Tracheobronchial Suction Catheter Kit|1||N|N||868.6810|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
AN|AN|OFS|Tracheal Suction Set (Kit)|1||N|N||868.6810|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
AN|AN|OFT|Spinal Epidural Anesthesia Kit|2||N|N||868.5120|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
AN|AN|OFU|Spinal Anesthesia Kit|2||N|N||868.5120|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
AN|AN|OFV|Regional Anesthesia Kit|2||N|N||868.5120|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
AN|AN|OFZ|Blood Specimen Collection Kit (Excludes Hiv Testing)|1||N|N||868.1100|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
AN|AN|OGA|Brachial Plexus Anesthesia Kit|2||N|N||868.5140|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
AN|AN|OGB|Caudal Anesthesia Kit|2||N|N||868.5140|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
AN|AN|OGC|Continuous Brachial Plexus Block Tray (Kit)|2||N|N||868.5150|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
AN|AN|OGD|Custom Anesthesia Kit|2||N|N||868.5120|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
AN|AN|OGE|Epidural Anesthesia Kit|2||N|N||868.5120|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
AN|AN|OGF|Glossopharyngeal Anesthesia Kit|2||N|N||868.5120|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
AN|AN|OGG|Humidifier Nebulizer Kit|2||N|N||868.5450|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
AN|AN|OGH|Laryngoscope Kit|1||N|N||868.5540|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
AN|AN|OGI|Nasal Endotracheal Tube Holder Kit|1||N|N||868.5770|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
AN|AN|OGJ|Nerve Block Tray (Kit)|2||N|N||868.5140|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
AN|AN|OGK|Orotrachael Intubation Guide Kit|2||N|N||868.1400|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
AN|AN|OGL|Oxygen Administration Kit|2||N|N||868.5655|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
AN|AN|OLF|Medevac Use Oxygen Generator|2||N|N||868.5440|1|A MEDEVAC oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve) to be used exclusively aboard a MEDEVAC helicopter and affixed to the helicopter.  For general use portable oxygen generators, use product code CAW.|oxygen concentrator, tubing, monitors and gauges, oxygen tank. This classification is only for oxygen generators that are used on MEDEVAC helicopters and are permanently affixed to the helicopter.  For general use oxygen generators use product code CAW.|This device uses a molecular sieve (for example zeolite) or other means to concentrate oxygen for medical use. For general use portable oxygen generators, use product code CAW.|This device is intended to provide oxygen for patients.|N|N
AN|AN|ONZ|Mechanical Ventilator|2||N|N||868.5895|1|This device is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable  of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregiver under the direction of a physician,|A small, wearable ventilator that interfaces with proprietary nasal and  tracheostomy patient interfaces.|The device  consists of two components: a ventilator and a patient interface. The device is a light-weight, portable, electronically timed and controlled volume assist ventilator.   The device delivers 100% oxygen in volumes of 50-250ml. The device delivers augmented volumes of 100% oxygen that are blended in the interface, patient's airway and lung with ambient air provided by the patient's spontaneous breath.|The device delivers augmented volumes of 100% oxygen into the patient's airway.|N|N
AN|AN|OQU|Airway Monitoring System|2||N|N||868.5730|1|The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip|The device is comprised of a small monitor and a sterile, single use adapter.|The device uses acoustic reflection technologyto generate an audible sound signal from a speaker and two microphones that receive acoustic reflections that arise from within the ETT tube|The device is placed in-line between the ventilator circuit and the proximal end of the endotracheal tube of a patient who is connected to a ventilator.|N|N
AN|AN|OYI|Non-Bronchoscopic Bronchoalveolar Lavage Catheter|1||N|N||868.6810|4|To perform non-bronchoscopic bronchoalveolar lavage (bal) in adult patients undergoing mechanical ventilation.|This device is a catheter|The device is inserted into a patient's lungs to collect bronchoalveolar labage specimens|Lungs|N|N
AN|AN|PHS|Oral Airway Assist|1||N|N||868.5110|4|To assist in maintaining an open airway.|Consists of Fortiflex B53-35H--1 1, High Density Polyethylene and is to be used with a latex strap.|To be placed in the mouth and increase the pharyngeal airspace.|The oropharyngeal space.|N|N
AN|AN|PHZ|Abnormal Breath Sound Device|2||N|N||868.1900|1|The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.|An electronic device|It is a hand-held electronic measurement device that utilizes  an acoustic sensor to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea for the presence of breath sounds such as wheeze.|Trachea|N|N
AN|CV|DPZ|Oximeter, Ear|2||N|N||870.2710|1|||||N|N
AN|CV|DQA|Oximeter|2||N|N||870.2700|1|||||N|N
AN|CV|NLF|Oximeter, Reprocessed|2||N|N||870.2700|1|same as DQA except reprocessed||||N|N
AN|CV|OCR|Lung Sound Monitor|2||N|Y||870.1875|4|The lung sound monitor is intended for use in monitoring and recording lung sounds.|The device consists of the arrays of electronic stethoscopes to collect the sound, a digital collector module, and is connected via cable to a PC workstation.|Uses electronic stethoscopes placed in an array on the pts. back to record sounds within 100-250Hz, the sounds recorded are converted from analog to digital, and through software, displayed in a gray-scale image.|Posterior thorax to record sounds emanating from the lungs.|N|N
AN|CV|PGJ|Oximeter, Wellness|2||N|N||870.2700|7|Pulse oximeter intended for wellness use.|Used to transmit light at known wavelengths(s) through blood using a light emitting diode(s) and sensor.|Transmit light at a known wavelength(s) through blood to measure photoplethysmographic data based on the amount of reflected or scattered light.|Circulatory pulse|N|N
AN|DE|OZR|Intraoral Pressure Gradient Device|2||N|N||872.5570|1|This intraoral device is electrically powered and operates by reducing the pressure in the oral cavity (by way of tubing and a noninvasive oral interface) to create a continuous positive pressure gradient from the airway to the oral cavity that urges the soft palate and tongue forward.  It is intended to be used while a patient is sleeping to treat obstructive sleep apnea.|Mouthpiece, Tubing, Negative Pressure Console|Negative Pressure|Oral Cavity|N|N
AN|EN|LLO|Laser, Neodymium:Yag, Pulmonary Surgery|2||N|P||874.4500|1|||||N|N
AN|GU|NQV|Catheter, Suction, Trachbronchial, Reprocessed|1||N|N||876.4680|1|A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.||||N|N
AN|NE|GZE|Implanted Diaphragmatic/Phrenic Nerve Stimulator|3||N|N||882.5830|2|Call for pmas to be filed by 7/7/86 per 51 fr 12101 on 4/8/86||||Y|N
AN|PM|PCM|Portable Liquid Oxygen Unit Stand|1||N|N||890.5050|4|To assist the user with refilling a portable liquid oxygen tank from a reservoir unit by holding the portable liquid oxygen tank in an upright position.|Portable Liquid Oxygen Unit|physically maintains the portable liquid oxygen tank in an upright position|portable liquid oxygen tanks and reservoir units|N|N
AN|SU|OMT|Absorbable Lung Biopsy Plug|2||N|N||878.4755|1|A pre-formed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle lung biopsies.  Upon, deployment into the biopsy tract, the plug expands to fill the biopsy void and remains in place until resorbed.|Polymerized hydrogel plug, cylindrical in shape and placed by a deployment system following lung biopsy by smaller biopsy needle/instrument.|Upon deployment into a lung biopsy tract, the plug expands to fill the biopsy void provide closure of the biopsy void.|to be used in the lung, specifically in punctures left by percutenous, transthoracic needles|Y|N
AN||BSD|Analyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling|3||N|N|||2|||||N|N
AN||ECX|Cylinder, Compressed Gas, And Valve|U|1|N|N|||1|||||N|N
AN||LHX|Trousers, Anti-Shock|U|1|N|N|||1|||||N|N
AN||LSZ|Ventilator, High Frequency|3||N|N|||2|||||N|N
AN||LXO|Analyzer, Hydrogen Gas|U|1|N|N|||1|||||N|N
AN||LYM|Device, Cpr Assist|U|1|N|N|||1|||||N|N
AN||MNQ|Stimulator, Hypoglossal Nerve, Implanted, Apnea|3||N|N|||2|||||Y|N
AN||OIR|Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator|f||N|N|||6|The device is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day.  For use only in patients 18 years of age or older.|implanted electrodes, stimulator control, clinical programming station|provides electrical stimulation for diaphragm movement|diaphragm|Y|Y
AN||OOY|Bronchial Thermoplasty System|3||N|N|||2|Bronchial thermoplasty systems are intended for the treatment of severe persistent asthma in patients whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists to reduce the effects of their asthma by using thermal radiofrequency energy to ablate smooth muscle tissue in the patient's airways.|Bronchial thermoplasty systems are composed of a catheter with an electrode that delivers radiofrequency (RF) energy to the airways, as well as an controller unit that generates RF energy and controls the parameters of delivery.|Bronchial thermoplasty systems use radiofrequency (RF) energy to ablate smooth muscle tissue in the airways.|Bronchial thermoplasty systems target the airways of the lung and the smooth muscle that lines the airway lumen.|N|N
AN||PDR|Computer-Assisted Personalized Sedation System|3||N|N|||2|Computer assisted system to administer a drug and control depth of sedation and provide monitoring and alarms for physiological vital signs and other parameters of sedation.|Computer controlled infusion pump, multi-parameter physiological monitoring, negative feedback control system algorithm.|Computer assisted drug administration using feedback from patient physiological parameters.|Central nervous system, cardiopulmonary system.|N|N
CH|CH|CCY|Zimmerman (Spectrophotometric), 17-Ketosteroids|1||N|N||862.1430|4|||||N|N
CH|CH|CCZ|Zimmerman/Norymberski, 17-Ketogenic Steroids|1||N|N||862.1385|4|||||N|N
CH|CH|CDA|Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin|1||N|N||862.1390|4|||||N|N
CH|CH|CDB|Porter Silber Hydrazone, 17-Hydroxycorticosteroids|1||N|N||862.1385|4|||||N|N
CH|CH|CDC|L-Leucyl B-Naphthylamide, Leucine Aminopeptidase|1||N|N||862.1460|4|||||N|N
CH|CH|CDD|Radioassay, Vitamin B12|2||N|P||862.1810|1|||||N|N
CH|CH|CDE|Chromatographic Separation/Zimmerman, 17-Ketosteroids|1||N|N||862.1430|4|||||N|N
CH|CH|CDF|Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin|1||N|N||862.1795|4|||||N|N
CH|CH|CDG|Chromatography Separation/Zimmerman 17-Ketogenic Steroids|1||N|N||862.1385|4|||||N|N
CH|CH|CDH|Acid, Uric, Phosphotungstate Reduction|1||N|Y||862.1775|7|||||N|N
CH|CH|CDK|Acid, Vanilmandelic, Electrophoretic Separation|1||N|N||862.1795|4|||||N|N
CH|CH|CDL|Berthelot Indophenol, Urea Nitrogen|2||N|Y||862.1770|1|||||N|N
CH|CH|CDM|Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)|1||N|N||862.1785|4|||||N|N
CH|CH|CDN|Urease, Photometric, Urea Nitrogen|2||N|Y||862.1770|1|||||N|N
CH|CH|CDO|Acid, Uric, Uricase (U.V.)|1||N|Y||862.1775|7|||||N|N
CH|CH|CDP|Radioimmunoassay, Total Triiodothyronine|2||N|N||862.1710|4|||||N|N
CH|CH|CDQ|Urease And Glutamic Dehydrogenase, Urea Nitrogen|2||N|Y||862.1770|1|||||N|N
CH|CH|CDR|1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine|1||N|Y||862.1730|1|||||N|N
CH|CH|CDS|Electrode, Ion Specific, Urea Nitrogen|2||N|Y||862.1770|1|||||N|N
CH|CH|CDT|Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides|1||N|N||862.1705|4|||||N|N
CH|CH|CDW|Diacetyl-Monoxime, Urea Nitrogen|2||N|Y||862.1770|1|||||N|N
CH|CH|CDX|Radioimmunoassay, Total Thyroxine|2||N|P||862.1700|4|||||N|N
CH|CH|CDZ|Radioimmunoassay, Testosterones And Dihydrotestosterone|1||N|Y||862.1680|1|||||N|N
CH|CH|CEA|Tlc Chromatographic Separation Triglycerides|1||N|N||862.1705|4|||||N|N
CH|CH|CEC|Radioimmunoassay, Free Thyroxine|2||N|P||862.1695|1|||||N|N
CH|CH|CED|5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase|1||N|N||862.1520|4|||||N|N
CH|CH|CEE|Radioimmunoassay, Thyroxine-Binding Globulin|2||N|P||862.1685|7|||||N|N
CH|CH|CEF|Electrophoretic, Protein Fractionation|1||N|N||862.1630|4|||||N|N
CH|CH|CEI|Uranyl Acetate/Zinc Acetate, Sodium|2||N|Y||862.1665|1|||||N|N
CH|CH|CEJ|Tetraphenyl Borate, Colorimetry, Potassium|2||N|Y||862.1600|1|||||N|N
CH|CH|CEK|Biuret (Colorimetric), Total Protein|2||N|N||862.1635|4|||||N|N
CH|CH|CEL|Ammonium Molybdate And Ammonium Vanadate, Phospholipids|1||N|N||862.1575|4|||||N|N
CH|CH|CEM|Electrode, Ion Specific, Potassium|2||N|Y||862.1600|1|||||N|N
CH|CH|CEN|Dye-Indicator, Ph (Urinary, Non-Quant.)|1||N|N||862.1550|4|||||N|N
CH|CH|CEO|Phosphomolybdate (Colorimetric), Inorganic Phosphorus|1||N|Y||862.1580|7|||||N|N
CH|CH|CEP|Radioimmunoassay, Luteinizing Hormone|1||N|N||862.1485|4|||||N|N
CH|CH|CEQ|Molybdenum Blue Method, Phospholipids|1||N|N||862.1575|4|||||N|N
CH|CH|CER|2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase|2||N|N||862.1440|4|||||N|N
CH|CH|CES|Chromogenesis, Phenylketones (Urinary, Non-Quant.)|1||N|N||862.1560|4|||||N|N
CH|CH|CET|Olive Oil Emulsion (Turbidimetric), Lipase|1||N|N||862.1465|4|||||N|N
CH|CH|CEW|Radioimmunoassay, Parathyroid Hormone|2||N|P||862.1545|1|||||N|N
CH|CH|CEX|Chromatographic Separation, Lactate Dehydrogenase Isoenzymes|2||N|P||862.1445|7|||||N|N
CH|CH|CFA|Electrode, Ion Specific, Magnesium|1||N|Y||862.1495|1|||||N|N
CH|CH|CFB|Chromatographic Derivative, Total Lipids|1||N|N||862.1470|4|||||N|N
CH|CH|CFD|Sulfophosphovanillin, Colorimetry, Total Lipids|1||N|N||862.1470|4|||||N|N
CH|CH|CFE|Electrophoretic, Lactate Dehydrogenase Isoenzymes|2||N|P||862.1445|7|||||N|N
CH|CH|CFG|Oil Emulsion/Thymolphthalein (Titrimetric), Lipase|1||N|N||862.1465|4|||||N|N
CH|CH|CFH|Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase|2||N|N||862.1440|4|||||N|N
CH|CH|CFJ|Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase|2||N|N||862.1440|4|||||N|N
CH|CH|CFL|Radioimmunoassay, Human Growth Hormone|1||N|N||862.1370|4|||||N|N
CH|CH|CFM|Bathophenanthroline, Colorimetry, Iron (Non-Heme)|1||N|Y||862.1410|7|||||N|N
CH|CH|CFO|Titrimetric, Magnesium|1||N|Y||862.1495|1|||||N|N
CH|CH|CFP|Radioimmunoassay, Immunoreactive Insulin|1||N|N||862.1405|4|||||N|N
CH|CH|CFR|Hexokinase, Glucose|2||N|Y||862.1345|1|||||N|N
CH|CH|CFT|Radioimmunoassay, Prolactin (Lactogen)|1||N|N||862.1625|4|||||N|N
CH|CH|CFW|Copper Reduction, Glucose|2||N|Y||862.1345|1|||||N|N
CH|CH|CGA|Glucose Oxidase, Glucose|2||N|Y||862.1345|1|||||N|N
CH|CH|CGC|Radioimmunoassay, Gastrin|1||N|N||862.1325|4|||||N|N
CH|CH|CGD|Ferricyanide, Glucose|2||N|Y||862.1345|1|||||N|N
CH|CH|CGE|Orthotoluidine, Glucose|2||N|Y||862.1345|1|||||N|N
CH|CH|CGF|Radioimmunoassay, Estrone|1||N|N||862.1280|4|||||N|N
CH|CH|CGH|Electrophoretic, Globulin|1||N|N||862.1330|4|||||N|N
CH|CH|CGI|Radioimmunoassay, Estriol|1||N|N||862.1265|4|||||N|N
CH|CH|CGJ|Radioimmunoassay, Follicle-Stimulating Hormone|1||N|N||862.1300|4|||||N|N
CH|CH|CGL|Electrode, Ion Based, Enzymatic, Creatinine|2||N|Y||862.1225|1|||||N|N
CH|CH|CGN|Acid, Folic, Radioimmunoassay|2||N|P||862.1295|1|||||N|N
CH|CH|CGO|Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol|1||N|N||862.1175|4|||||N|N
CH|CH|CGR|Radioimmunoassay, Cortisol|2||N|P||862.1205|1|||||N|N
CH|CH|CGS|Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes|2||N|P||862.1215|1|||||N|N
CH|CH|CGT|Radioimmunoassay, Cyclic Gmp|2||N|P||862.1230|1|||||N|N
CH|CH|CGX|Alkaline Picrate, Colorimetry, Creatinine|2||N|Y||862.1225|1|||||N|N
CH|CH|CGZ|Electrode, Ion-Specific, Chloride|2||N|Y||862.1170|1|||||N|N
CH|CH|CHA|Radioimmunoassay, Corticosterone|1||N|N||862.1200|4|||||N|N
CH|CH|CHC|Titrimetric Permanganate And Bromophenol Blue, Calcium|2||N|P||862.1145|1|||||N|N
CH|CH|CHD|Acid, Ferric Ion-Sulfuric, Cholesterol|1||N|N||862.1175|4|||||N|N
CH|CH|CHE|Radioimmunoassay, Corticoids|1||N|N||862.1195|4|||||N|N
CH|CH|CHG|Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride|2||N|Y||862.1170|1|||||N|N
CH|CH|CHH|Enzymatic Esterase--Oxidase, Cholesterol|1||N|N||862.1175|4|||||N|N
CH|CH|CHI|Lipase-Esterase, Enzymatic, Photometric, Lipase|1||N|N||862.1465|4|||||N|N
CH|CH|CHJ|Mercuric Thiocyanate, Colorimetry, Chloride|2||N|Y||862.1170|1|||||N|N
CH|CH|CHK|Mercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride|2||N|Y||862.1170|1|||||N|N
CH|CH|CHL|Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph|2||N|P||862.1120|1|||||N|N
CH|CH|CHM|Radioimmunoassay, Total Estrogens In Pregnancy|1||N|N||862.1270|4|||||N|N
CH|CH|CHO|Radioimmunoassay, Cyclic Amp|2||N|P||862.1230|1|||||N|N
CH|CH|CHP|Radioimmunoassay, Estradiol|1||N|N||862.1260|4|||||N|N
CH|CH|CHQ|Chromatographic/Fluorometric Method, Catecholamines|1||N|N||862.1165|4|||||N|N
CH|CH|CHR|Titrimetric Phenol Red, Carbon-Dioxide|2||N|Y||862.1160|1|||||N|N
CH|CH|CHS|Coulometric Method, Carbon-Dioxide|2||N|Y||862.1160|1|||||N|N
CH|CH|CHT|Electrophoretic Method, Catecholamines|1||N|N||862.1165|4|||||N|N
CH|CH|CHW|Titrimetric With Edta And Indicator, Calcium|2||N|P||862.1145|1|||||N|N
CH|CH|CHZ|Di (O-Hydroxyphenylimine) Ethane, Calcium|2||N|P||862.1145|1|||||N|N
CH|CH|CIA|Methylthymol Blue, Calcium|2||N|P||862.1145|1|||||N|N
CH|CH|CIB|Radioimmunoassay, Angiotensin I And Renin|2||N|P||862.1085|1|||||N|N
CH|CH|CIC|Cresolphthalein Complexone, Calcium|2||N|P||862.1145|1|||||N|N
CH|CH|CID|Alizarin Sulfonate, Calcium|2||N|P||862.1145|1|||||N|N
CH|CH|CIE|Volumetric/Manometric, Carbon-Dioxide|2||N|Y||862.1160|1|||||N|N
CH|CH|CIF|Vanillin Pyruvate, Ast/Sgot|2||N|P||862.1100|7|||||N|N
CH|CH|CIG|Diazo Colorimetry, Bilirubin|2||N|P||862.1110|1|||||N|N
CH|CH|CIJ|Saccharogenic, Amylase|2||N|P||862.1070|1|||||N|N
CH|CH|CIK|Radial Diffusion, Amylase|2||N|P||862.1070|1|||||N|N
CH|CH|CIL|Cresol Red Colorimetry, Carbon-Dioxide|2||N|Y||862.1160|1|||||N|N
CH|CH|CIN|Electrophoretic Separation, Alkaline Phosphatase Isoenzymes|2||N|P||862.1050|1|||||N|N
CH|CH|CIO|Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes|2||N|P||862.1050|1|||||N|N
CH|CH|CIQ|Diazo, Ast/Sgot|2||N|P||862.1100|7|||||N|N
CH|CH|CIS|Hydrazone Colorimetry, Ast/Sgot|2||N|P||862.1100|7|||||N|N
CH|CH|CIT|Nadh Oxidation/Nad Reduction, Ast/Sgot|2||N|P||862.1100|4|||||N|N
CH|CH|CIW|Starch-Dye Bound Polymer, Amylase|2||N|P||862.1070|1|||||N|N
CH|CH|CIX|Bromcresol Green Dye-Binding, Albumin|2||N|P||862.1035|1|||||N|N
CH|CH|CIY|Radioimmunoassay, Androsterone|1||N|N||862.1080|4|||||N|N
CH|CH|CIZ|Radioimmunoassay, Androstenedione|1||N|N||862.1075|4|||||N|N
CH|CH|CJA|Amyloclastic, Amylase|2||N|N||862.1070|1|||||N|N
CH|CH|CJB|Chromatographic Separation/Radioimmunoassay, Aldosterone|2||N|P||862.1045|1|||||N|N
CH|CH|CJC|Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase|1||N|N||862.1040|4|||||N|N
CH|CH|CJD|Nitrosalicylate Reduction, Amylase|2||N|P||862.1070|1|||||N|N
CH|CH|CJE|Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes|2||N|P||862.1050|1|||||N|N
CH|CH|CJF|Tetrabromophenolphthalein, Albumin|2||N|P||862.1035|1|||||N|N
CH|CH|CJG|Tetrabromo-M-Cresolsulfonphthalein, Albumin|2||N|P||862.1035|1|||||N|N
CH|CH|CJH|Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes|2||N|P||862.1050|1|||||N|N
CH|CH|CJI|Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes|2||N|P||862.1050|1|||||N|N
CH|CH|CJJ|Diazo, Alt/Sgpt|1||N|N||862.1030|4|||||N|N
CH|CH|CJK|Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes|2||N|P||862.1050|1|||||N|N
CH|CH|CJL|Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes|2||N|P||862.1050|1|||||N|N
CH|CH|CJM|Radioimmunoassay, Aldosterone|2||N|P||862.1045|1|||||N|N
CH|CH|CJN|Acid Phosphatase, Nitrophenylphosphate|2||N|P||862.1020|7|||||N|N
CH|CH|CJO|Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes|2||N|P||862.1050|1|||||N|N
CH|CH|CJQ|Radial Immunodiffusion, Albumin|2||N|P||862.1035|1|||||N|N
CH|CH|CJR|Acid Phosphatase, Thymol Blue Monophosphate|2||N|P||862.1020|7|||||N|N
CH|CH|CJT|Hydrazone Colorimetry, Aldolase|1||N|N||862.1040|4|||||N|N
CH|CH|CJW|Bromcresol Purple Dye-Binding, Albumin|2||N|P||862.1035|1|||||N|N
CH|CH|CJX|Acid Phosphatase, Disodium Phenylphosphate|2||N|P||862.1020|7|||||N|N
CH|CH|CJY|Azo Dye, Calcium|2||N|P||862.1145|1|||||N|N
CH|CH|CJZ|Acid, Hydroxyazobenzene-Benzoic, Albumin|2||N|P||862.1035|1|||||N|N
CH|CH|CKA|Nadh Oxidation/Nad Reduction, Alt/Sgpt|1||N|N||862.1030|4|||||N|N
CH|CH|CKB|Acid Phosphatase, Naphthyl Phosphate|2||N|P||862.1020|7|||||N|N
CH|CH|CKC|Vanillin Pyruvate, Alt/Sgpt|1||N|N||862.1030|4|||||N|N
CH|CH|CKD|Hydrazone Colorimetry, Alt/Sgpt|1||N|N||862.1030|4|||||N|N
CH|CH|CKE|Acid Phosphatase, Thymolphthale Inmonophosphate|2||N|P||862.1020|7|||||N|N
CH|CH|CKF|Phenylphosphate, Alkaline Phosphatase Or Isoenzymes|2||N|P||862.1050|1|||||N|N
CH|CH|CKG|Radioimmunoassay, Acth|2||N|P||862.1025|1|||||N|N
CH|CH|CKH|Acid Phosphatase, Beta Glycerophosphate|2||N|P||862.1020|7|||||N|N
CH|CH|DHA|System, Test, Human Chorionic Gonadotropin|2||N|Y||862.1155|1|||||N|N
CH|CH|GIM|Tubes, Vacuum Sample, With Anticoagulant|2||N|P||862.1675|1|||||N|N
CH|CH|GJE|Tray, Blood Collection|2||N|P||862.1675|1|||||N|N
CH|CH|GLE|Mixer, Blood Tube|1||Y|N||862.2050|4|||||N|N
CH|CH|JBS|Timer, General Laboratory|1||Y|N||862.2050|4|||||N|N
CH|CH|JFH|Acid Phosphatase (Prostatic), Tartrate Inhibited|2||N|P||862.1020|7|||||N|N
CH|CH|JFJ|Catalytic Methods, Amylase|2||N|P||862.1070|1|||||N|N
CH|CH|JFL|Ph Rate Measurement, Carbon-Dioxide|2||N|Y||862.1160|1|||||N|N
CH|CH|JFM|Enzymatic Method, Bilirubin|2||N|P||862.1110|1|||||N|N
CH|CH|JFN|Atomic Absorption, Calcium|2||N|P||862.1145|1|||||N|N
CH|CH|JFO|Fluorometric, Calcium|2||N|P||862.1145|1|||||N|N
CH|CH|JFP|Electrode, Ion Specific, Calcium|2||N|P||862.1145|1|||||N|N
CH|CH|JFS|Coulometric, Chloride|2||N|Y||862.1170|1|||||N|N
CH|CH|JFT|Fluorometric, Cortisol|2||N|P||862.1205|1|||||N|N
CH|CH|JFY|Enzymatic Method, Creatinine|2||N|Y||862.1225|1|||||N|N
CH|CH|JGC|Tryptophan Measurement (Colorimetric), Globulin|1||N|N||862.1330|4|||||N|N
CH|CH|JGD|Nephelometric Method, Globulin|1||N|N||862.1330|4|||||N|N
CH|CH|JGE|Turbidimetric Method, Globulin|1||N|N||862.1330|4|||||N|N
CH|CH|JGF|Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes|2||N|P||862.1445|7|||||N|N
CH|CH|JGG|L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase|1||N|N||862.1460|4|||||N|N
CH|CH|JGI|Atomic Absorption, Magnesium|1||N|Y||862.1495|1|||||N|N
CH|CH|JGJ|Photometric Method, Magnesium|1||N|Y||862.1495|1|||||N|N
CH|CH|JGK|Ferric Chloride, Phenylketones (Urinary, Non-Quant.)|1||N|N||862.1560|4|||||N|N
CH|CH|JGM|Flame Photometry, Potassium|2||N|Y||862.1600|1|||||N|N
CH|CH|JGP|Lowry (Colorimetric), Total Protein|2||N|N||862.1635|4|||||N|N
CH|CH|JGQ|Turbidimetric, Total Protein|2||N|N||862.1635|4|||||N|N
CH|CH|JGR|Refractometric, Total Protein|2||N|N||862.1635|4|||||N|N
CH|CH|JGS|Electrode, Ion Specific, Sodium|2||N|Y||862.1665|1|||||N|N
CH|CH|JGT|Flame Photometry, Sodium|2||N|Y||862.1665|1|||||N|N
CH|CH|JGW|Fluorometric Method, Triglycerides|1||N|N||862.1705|4|||||N|N
CH|CH|JGX|Turbidimetric Method, Triglycerides|1||N|N||862.1705|4|||||N|N
CH|CH|JGY|Colorimetric Method, Triglycerides|1||N|N||862.1705|4|||||N|N
CH|CH|JGZ|O-Phthalaldehyde, Urea Nitrogen|2||N|Y||862.1770|1|||||N|N
CH|CH|JHA|Acid, Uric, Uricase (Gasometric)|1||N|Y||862.1775|7|||||N|N
CH|CH|JHC|Acid, Uric, Uricase (Oxygen Rate)|1||N|Y||862.1775|7|||||N|N
CH|CH|JHD|Fluorometric Method, 17-Hydroxycorticosteroids|1||N|N||862.1385|4|||||N|N
CH|CH|JHE|Radioassay, 17-Hydroxycorticosteroids|1||N|N||862.1385|4|||||N|N
CH|CH|JHF|Colorimetric Method, Lecithin/Sphingomyelin Ratio|2||N|P||862.1455|1|||||N|N
CH|CH|JHG|Chromatographic Separation, Lecithin/Sphingomyelin Ratio|2||N|P||862.1455|1|||||N|N
CH|CH|JHH|Electrophoretic Method, Lecithin/Sphingomyelin Ratio|2||N|P||862.1455|1|||||N|N
CH|CH|JHI|Visual, Pregnancy Hcg, Prescription Use|2||N|Y||862.1155|1|||||N|N
CH|CH|JHJ|Agglutination Method, Human Chorionic Gonadotropin|2||N|Y||862.1155|1|||||N|N
CH|CH|JHL|Microdensitometry Method, Lipoproteins|1||N|N||862.1475|4|||||N|N
CH|CH|JHM|Colorimetric Method, Lipoproteins|1||N|N||862.1475|4|||||N|N
CH|CH|JHN|Turbidimetric Method, Lipoproteins|1||N|N||862.1475|4|||||N|N
CH|CH|JHO|Electrophoretic Separation, Lipoproteins|1||N|N||862.1475|4|||||N|N
CH|CH|JHP|Radial Immunodiffusion, Lipoproteins|1||N|N||862.1475|4|||||N|N
CH|CH|JHQ|Nephelometric Method, Lipoproteins|1||N|N||862.1475|4|||||N|N
CH|CH|JHS|Differential Rate Kinetic Method, Cpk Or Isoenzymes|2||N|P||862.1215|1|||||N|N
CH|CH|JHT|Chromatographic Separation, Cpk Isoenzymes|2||N|P||862.1215|1|||||N|N
CH|CH|JHW|U.V. Method, Cpk Isoenzymes|2||N|P||862.1215|1|||||N|N
CH|CH|JHX|Fluorometric Method, Cpk Or Isoenzymes|2||N|P||862.1215|1|||||N|N
CH|CH|JHY|Colorimetric Method, Cpk Or Isoenzymes|2||N|P||862.1215|1|||||N|N
CH|CH|JIA|Enzymatic Methods, Galactose|1||N|Y||862.1310|1|||||N|N
CH|CH|JIB|U.V. Method, Galactose|1||N|Y||862.1310|1|||||N|N
CH|CH|JIC|Colorimetric Method, Galactose|1||N|Y||862.1310|1|||||N|N
CH|CH|JID|Photometric Method, Ammonia|1||N|Y||862.1065|1|||||N|N
CH|CH|JIE|Method, Ion-Exchange, Ammonia|1||N|Y||862.1065|1|||||N|N
CH|CH|JIF|Enzymatic Method, Ammonia|1||N|Y||862.1065|1|||||N|N
CH|CH|JIG|Electrode, Ion-Specific Method, Ammonia|1||N|Y||862.1065|1|||||N|N
CH|CH|JIJ|Wet Ash Method, Protein-Bound Iodine|1||N|N||862.1640|4|||||N|N
CH|CH|JIK|Dry Ash Method, Protein-Bound Iodine|1||N|N||862.1640|4|||||N|N
CH|CH|JIL|Method, Enzymatic, Glucose (Urinary, Non-Quantitative)|2||N|Y||862.1340|1|||||N|N
CH|CH|JIM|Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative)|2||N|P||862.1340|1|||||N|N
CH|CH|JIN|Nitroprusside, Ketones (Urinary, Non-Quant.)|1||N|N||862.1435|4|||||N|N
CH|CH|JIQ|Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)|1||N|N||862.1645|4|||||N|N
CH|CH|JIR|Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)|1||N|N||862.1645|4|||||N|N
CH|CH|JIS|Calibrator, Primary|2||N|Y||862.1150|1|||||N|N
CH|CH|JIT|Calibrator, Secondary|2||N|Y||862.1150|1|||||N|N
CH|CH|JIW|Calibrator, Surrogate|2||N|Y||862.1150|1|||||N|N
CH|CH|JIX|Calibrator, Multi-Analyte Mixture|2||N|Y||862.1150|1|||||N|N
CH|CH|JIY|Photometric Method, Iron (Non-Heme)|1||N|Y||862.1410|7|||||N|N
CH|CH|JIZ|Atomic Absorption, Iron (Non-Heme)|1||N|Y||862.1410|7|||||N|N
CH|CH|JJA|Radio-Labeled Iron Method, Iron (Non-Heme)|1||N|Y||862.1410|7|||||N|N
CH|CH|JJB|Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)|1||N|N||862.1115|4|||||N|N
CH|CH|JJC|Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use|1||N|N||862.2150|4|||||N|N
CH|CH|JJE|Analyzer, Chemistry (Photometric, Discrete), For Clinical Use|1||N|N||862.2160|4|||||N|N
CH|CH|JJF|Analyzer, Chemistry, Micro, For Clinical Use|1||N|N||862.2170|4|||||N|N
CH|CH|JJG|Analyzer, Chemistry, Centrifugal, For Clinical Use|1||N|N||862.2140|4|||||N|N
CH|CH|JJH|Clinical Sample Concentrator|1||N|N||862.2310|4|||||N|N
CH|CH|JJI|Analyzer, Enzyme, For Clinical Use|1||N|N||862.2500|4|||||N|N
CH|CH|JJJ|Counter (Beta, Gamma) For Clinical Use|1||N|N||862.2320|4|||||N|N
CH|CH|JJK|Oncometer, Plasma, For Clinical Use|1||N|N||862.2720|4|||||N|N
CH|CH|JJL|Plasma Viscometer For Clinical Use|1||N|N||862.2920|4|||||N|N
CH|CH|JJM|Osmometer For Clinical Use|1||N|N||862.2730|4|||||N|N
CH|CH|JJN|Apparatus, Electrophoresis, For Clinical Use|1||N|N||862.2485|4|||||N|N
CH|CH|JJO|Flame Emission Photometer For Clinical Use|1||N|N||862.2540|4|||||N|N
CH|CH|JJP|Electrode, Ion Selective (Non-Specified)|1||Y|N||862.2050|4|||||N|N
CH|CH|JJQ|Colorimeter, Photometer, Spectrophotometer For Clinical Use|1||N|N||862.2300|4|||||N|N
CH|CH|JJR|Electrolyte Controls (Assayed And Unassayed)|1||N|Y||862.1660|1|||||N|N
CH|CH|JJS|Controls For Blood-Gases, (Assayed And Unassayed)|1||N|Y||862.1660|1|||||N|N
CH|CH|JJT|Enzyme Controls (Assayed And Unassayed)|1||N|Y||862.1660|1|||||N|N
CH|CH|JJW|Urinalysis Controls (Assayed And Unassayed)|1||N|Y||862.1660|1|||||N|N
CH|CH|JJX|Single (Specified) Analyte Controls (Assayed And Unassayed)|1||N|Y||862.1660|1|||||N|N
CH|CH|JJY|Multi-Analyte Controls, All Kinds (Assayed)|1||N|Y||862.1660|1|||||N|N
CH|CH|JKA|Tubes, Vials, Systems, Serum Separators, Blood Collection|2||N|P||862.1675|1|||||N|N
CH|CH|JKB|Radioimmunoassay, Compound S (11-Deoxycortisol)|1||N|N||862.1185|4|||||N|N
CH|CH|JKC|Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)|1||N|N||862.1245|4|||||N|N
CH|CH|JKD|Radioimmunoassay, C-Peptides Of Proinsulin|1||N|N||862.1135|4|||||N|N
CH|CH|JKF|Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge|1||N|N||862.1380|4|||||N|N
CH|CH|JKG|L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase|1||N|N||862.1420|4|||||N|N
CH|CH|JKH|Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen|1||N|N||862.1420|4|||||N|N
CH|CH|JKJ|Fluorometric Measurement, Porphyrins|1||N|N||862.1595|4|||||N|N
CH|CH|JKL|Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry|1||N|N||862.1060|4|||||N|N
CH|CH|JKP|Chromium-51, Blood Volume|1||N|N||862.1130|4|||||N|N
CH|CH|JKR|Radioimmunoassay, Calcitonin|2||N|P||862.1140|1|||||N|N
CH|CH|JKW|N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin|1||N|N||862.1180|4|||||N|N
CH|CH|JKX|N-Benzoyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin|1||N|N||862.1180|4|||||N|N
CH|CH|JKY|Oxalydihydrazide (Spectroscopic), Copper|1||N|N||862.1190|4|||||N|N
CH|CH|JKZ|Diethyldithiocarbamate (Colorimetric), Copper|1||N|N||862.1190|4|||||N|N
CH|CH|JLA|Conversion To Creatinine, Creatine|1||N|N||862.1210|4|||||N|N
CH|CH|JLB|Atp And Creatine Kinase (Enzymatic), Creatine|1||N|N||862.1210|4|||||N|N
CH|CH|JLC|Nitroprusside Reaction (Qualitative, Urine), Cystine|1||N|N||862.1240|4|||||N|N
CH|CH|JLD|Chromatographic, Cystine|1||N|N||862.1240|4|||||N|N
CH|CH|JLE|Radioimmunoassay, Desoxycorticosterone|1||N|N||862.1250|4|||||N|N
CH|CH|JLF|Radioimmunoassay, Etiocholanolone|1||N|N||862.1285|4|||||N|N
CH|CH|JLG|Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids|1||N|N||862.1290|4|||||N|N
CH|CH|JLH|Titrimetric, Fatty Acids|1||N|N||862.1290|4|||||N|N
CH|CH|JLI|Tetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid|1||N|N||862.1305|4|||||N|N
CH|CH|JLJ|Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate|2||N|P||862.1315|1|||||N|N
CH|CH|JLK|Sodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity|1||N|N||862.1320|4|||||N|N
CH|CH|JLL|Tubeless Analysis, Gastric Acidity|1||N|N||862.1320|4|||||N|N
CH|CH|JLN|Chromatographic, Glutathione|1||N|N||862.1365|4|||||N|N
CH|CH|JLO|Enzymatic (Glutathione Reductase), Glutathione|1||N|N||862.1365|4|||||N|N
CH|CH|JLP|Spectrophotometric Method, Pregnanediol|1||N|N||862.1605|4|||||N|N
CH|CH|JLQ|Spectrophotometric Method, Pregnanetriol|1||N|N||862.1610|4|||||N|N
CH|CH|JLR|Gas Chromatography, Pregnanetriol|1||N|N||862.1610|4|||||N|N
CH|CH|JLS|Radioimmunoassay, Progesterone|1||N|N||862.1620|4|||||N|N
CH|CH|JLT|Acid, Pyruvic, Enzymatic (U.V.)|1||N|N||862.1655|4|||||N|N
CH|CH|JLW|Radioimmunoassay, Thyroid-Stimulating Hormone|2||N|P||862.1690|1|||||N|N
CH|CH|JLX|Radioimmunoassay, 17-Hydroxyprogesterone|1||N|N||862.1395|4|||||N|N
CH|CH|JLY|Phosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric Acid|1||N|N||862.1255|4|||||N|N
CH|CH|JLZ|Nadh, Phosphoglycerate Mutase, Atp (U.V.) 2,3-Diphosphoglyceric Acid|1||N|N||862.1255|4|||||N|N
CH|CH|JMA|Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)|1||N|N||862.1095|4|||||N|N
CH|CH|JMD|Radioimmunoassay, Total Estrogens, Nonpregnancy|1||N|N||862.1275|4|||||N|N
CH|CH|JME|Radioimmunoassay, Glucagon|1||N|N||862.1335|4|||||N|N
CH|CH|JMF|Radioimmunoassay, Human Placental Lactogen|2||N|P||862.1585|1|||||N|N
CH|CH|JMI|Chromatographic, Histidine|1||N|N||862.1375|4|||||N|N
CH|CH|JMJ|Microbiological, Histidine|1||N|N||862.1375|4|||||N|N
CH|CH|JMK|Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase|1||N|N||862.1380|4|||||N|N
CH|CH|JMM|Column Chromatography & Color Development, Hydroxyproline|1||N|N||862.1400|4|||||N|N
CH|CH|JMN|Extraction Plus Chromatography With Color By Ninhydrin, Hydroxyproline|1||N|N||862.1400|4|||||N|N
CH|CH|JMO|Ferrozine (Colorimetric) Iron Binding Capacity|1||N|Y||862.1415|7|||||N|N
CH|CH|JMQ|M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)|1||N|N||862.1490|4|||||N|N
CH|CH|JMR|Immunochemical, Lysozyme (Muramidase)|1||N|N||862.1490|4|||||N|N
CH|CH|JMS|Acid, Oxalacetic And Nadh Oxidation (U.V.), Malic Dehydrogenase|1||N|N||862.1500|4|||||N|N
CH|CH|JMT|Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)|1||N|N||862.1510|4|||||N|N
CH|CH|JMW|2,4-Dinitrofluorobenzene (Spectroscopic), Nitrogen (Amino-Nitrogen)|1||N|N||862.1515|4|||||N|N
CH|CH|JMX|Ninhydrin, Nitrogen (Amino-Nitrogen)|1||N|N||862.1515|4|||||N|N
CH|CH|JMY|Citrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transferase|1||N|N||862.1535|4|||||N|N
CH|CH|JMZ|Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality|1||N|N||862.1540|4|||||N|N
CH|CH|JNA|Vapor Pressure, Osmolality Of Serum & Urine|1||N|N||862.1540|4|||||N|N
CH|CH|JNB|Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine|2||N|P||862.1555|1|||||N|N
CH|CH|JNC|Column Or Paper Chromatography Plus Ninhydrin, Phenylalanine|2||N|P||862.1555|1|||||N|N
CH|CH|JND|Nadp Reduction, 6-Phosphogluconate Dehydrogenase|1||N|N||862.1565|4|||||N|N
CH|CH|JNE|Glucose-6-Phosphate (Colorimetric), Phosphohexose Isomerase|1||N|N||862.1570|4|||||N|N
CH|CH|JNF|Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen|1||N|N||862.1590|4|||||N|N
CH|CH|JNG|Radioimmunoassay, Pregnenolone|1||N|N||862.1615|4|||||N|N
CH|CH|JNJ|Phosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase|1||N|N||862.1650|4|||||N|N
CH|CH|JNK|Beta-D-Fructose & Nadh Oxidation (U.V.), Sorbitol Dehydrogenase|1||N|N||862.1670|4|||||N|N
CH|CH|JNN|P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin|1||N|N||862.1725|4|||||N|N
CH|CH|JNO|N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin|1||N|N||862.1725|4|||||N|N
CH|CH|JNP|Infrared Spectroscopy Measurement, Urinary Calculi (Stone)|1||N|N||862.1780|4|||||N|N
CH|CH|JNQ|Qualitative Chemical Reactions, Urinary Calculi (Stone)|1||N|N||862.1780|4|||||N|N
CH|CH|JNS|Stannous Chloride - Hydrazine, Phospholipids|1||N|N||862.1575|4|||||N|N
CH|CH|JNT|Chromatographic, Phospholipids|1||N|N||862.1575|4|||||N|N
CH|CH|JNX|Membrane Osmometry, Plasma Oncometry|1||N|N||862.1530|4|||||N|N
CH|CH|JNY|Glyceralde-3-Phosphate, Nadh (Enzymatic), Triose Phosphate Isomerase|1||N|N||862.1720|4|||||N|N
CH|CH|JNZ|Fluorometric, Uroporphyrin|1||N|N||862.1790|4|||||N|N
CH|CH|JOA|Acid, Trifluoroacetic, Vitamin A, Hexane Extraction|1||N|N||862.1805|4|||||N|N
CH|CH|JOB|Hexane Extraction, Fluorescence, Vitamin E|1||N|N||862.1815|4|||||N|N
CH|CH|JOC|Colorimetric, Xylose|1||N|N||862.1820|4|||||N|N
CH|CH|JPZ|Colorimetric Method, Gamma-Glutamyl Transpeptidase|1||N|N||862.1360|4|||||N|N
CH|CH|JQA|Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes|1||N|N||862.1360|4|||||N|N
CH|CH|JQB|Kinetic Method, Gamma-Glutamyl Transpeptidase|1||N|N||862.1360|4|||||N|N
CH|CH|JQC|Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use|1||Y|N||862.2050|4|||||N|N
CH|CH|JQD|Resin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capacity|1||N|Y||862.1415|7|||||N|N
CH|CH|JQE|Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity|1||N|Y||862.1415|7|||||N|N
CH|CH|JQF|Bathophenanthroline, Iron Binding Capacity|1||N|Y||862.1415|7|||||N|N
CH|CH|JQG|Radiometric, Fe59, Iron Binding Capacity|1||N|Y||862.1415|7|||||N|N
CH|CH|JQH|Trinitrobenzene Sulfonate (Spectroscopic), Nitrogen (Amino-Nitrogen)|1||N|N||862.1515|4|||||N|N
CH|CH|JQI|Rotating Disc, Plasma Viscometry|1||N|N||862.1475|4|||||N|N
CH|CH|JQJ|Densitometeric, Protein Fractionation|1||N|N||862.1630|4|||||N|N
CH|CH|JQK|Immunodiffusion, Protein Fractionation|1||N|N||862.1630|4|||||N|N
CH|CH|JQL|Spectrophotometric, Uroporphyrin|1||N|N||862.1790|4|||||N|N
CH|CH|JQM|P-Bromoaniline, Xylose|1||N|N||862.1820|4|||||N|N
CH|CH|JQN|Colorimetric, Mucopolysaccharides|1||N|N||862.1505|4|||||N|N
CH|CH|JQO|Balance, Analytical|1||Y|N||862.2050|4|||||N|N
CH|CH|JQP|Calculator/Data Processing Module, For Clinical Use|1||N|N||862.2100|4|||||N|N
CH|CH|JQQ|Dialyzer|1||Y|N||862.2050|4|||||N|N
CH|CH|JQT|Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica|1||N|N||862.2400|4|||||N|N
CH|CH|JQW|Station, Pipetting And Diluting, For Clinical Use|1||N|N||862.2750|4|||||N|N
CH|CH|JQX|Nephelometer, For Clinical Use|1||N|N||862.2700|4|||||N|N
CH|CH|JQY|Ph Meter|1||Y|N||862.2050|4|||||N|N
CH|CH|JQZ|Polarimeter|1||Y|N||862.2050|4|||||N|N
CH|CH|JRA|Microtitrator, For Clinical Use|1||N|N||862.2680|4|||||N|N
CH|CH|JRB|Micro Mixer|1||Y|N||862.2050|4|||||N|N
CH|CH|JRC|Micro Pipette|1||Y|N||862.2050|4|||||N|N
CH|CH|JRE|Refractometer For Clinical Use|1||N|N||862.2800|4|||||N|N
CH|CH|JRG|Block, Heating|1||Y|N||862.2050|4|||||N|N
CH|CH|JRI|Curvette, Thermostated|1||Y|N||862.2050|4|||||N|N
CH|CH|JRJ|Unit, Drying|1||Y|N||862.2050|4|||||N|N
CH|CH|JRK|Evaporator|1||Y|N||862.2050|4|||||N|N
CH|CH|JRL|Unit, Filter, Membrane|1||Y|N||862.2050|4|||||N|N
CH|CH|JRM|Freezer|1||Y|N||862.2050|4|||||N|N
CH|CH|JRO|Blender/Mixer|1||Y|N||862.2050|4|||||N|N
CH|CH|JRQ|Shaker/Stirrer|1||Y|N||862.2050|4|||||N|N
CH|CH|JRR|Regulator, Temperature|1||Y|N||862.2050|4|||||N|N
CH|CH|JRS|Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)|1||Y|N||862.2050|4|||||N|N
CH|CH|KHM|Nephelometric, Amylase|2||N|P||862.1070|1|||||N|N
CH|CH|KHO|Fluorometer, For Clinical Use|1||N|N||862.2560|4|||||N|N
CH|CH|KHP|Acid, Lactic, Enzymatic Method|1||N|N||862.1450|4|||||N|N
CH|CH|KHQ|Radioassay, Triiodothyronine Uptake|2||N|N||862.1715|4|||||N|N
CH|CH|KHS|Enzymatic, Carbon-Dioxide|2||N|Y||862.1160|1|||||N|N
CH|CH|KLI|Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine|2||N|P||862.1700|4|||||N|N
CH|CH|KLJ|Nad Reduction (U.V.), Phosphohexose Isomerase|1||N|N||862.1570|4|||||N|N
CH|CH|KMS|Phenolphthalein Colorimetry, Carbon-Dioxide|2||N|Y||862.1160|1|||||N|N
CH|CH|KNK|Acid, Uric, Uricase (Colorimetric)|1||N|Y||862.1775|4|||||N|N
CH|CH|KQN|Radioassay, Angiotensin Converting Enzyme|2||N|P||862.1090|7|||||N|N
CH|CH|KQO|Automated Urinalysis System|1||N|N||862.2900|4|||||N|N
CH|CH|KQP|Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase|2||N|P||862.1315|1|||||N|N
CH|CH|KWW|Radioimmunoassay, Cholyglycine, Bile Acids|2||N|P||862.1177|1|||||N|N
CH|CH|KWX|Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids|2||N|P||862.1187|1|||||N|N
CH|CH|LBR|Ldl & Vldl Precipitation, Hdl|1||N|N||862.1475|4|||||N|N
CH|CH|LBS|Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl|1||N|N||862.1475|4|||||N|N
CH|CH|LBT|Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl|1||N|N||862.1475|4|||||N|N
CH|CH|LCH|Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical|1||N|Y||862.1660|1|||||N|N
CH|CH|LCI|Automated Radioimmunoassay Systems, For Clinical Use|1||N|N||862.2050|1|||||N|N
CH|CH|LCX|Kit, Test, Pregnancy, Hcg, Over The Counter|2||N|N||862.1155|1|||||N|N
CH|CH|LFP|Conductivity Rate, Urea Nitrogen|2||N|Y||862.1770|1|||||N|N
CH|CH|LFQ|Acid, Uric, Acid Reduction Of Ferric Ion|1||N|Y||862.1775|7|||||N|N
CH|CH|LFR|Glucose Dehydrogenase, Glucose|2||N|Y||862.1345|1|||||N|N
CH|CH|LFS|Radioreceptor Assay, Human Chorionic Gonadotropin|2||N|Y||862.1155|1|||||N|N
CH|CH|LIG|Radioassay, Intrinsic Factor Blocking Antibody|2||N|P||862.1810|1|||||N|N
CH|CH|LPS|Urinary Homocystine (Nonquantitative) Test System|2||N|P||862.1377|1|||||N|N
CH|CH|LPT|System, Test, Urinary Methylmalonic Acid|2||N|P||862.1509|7|||||N|N
CH|CH|LPW|System, Test, Oxalate|1||N|N||862.1542|4|||||N|N
CH|CH|LXG|Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use|1||Y|N||862.2050|4|||||N|N
CH|CH|MMI|Immunoassay Method, Troponin Subunit|2||N|P||862.1215|1|||||N|N
CH|CH|MPG|Urinary Carbohydrate Analysis Kit|1||N|N||862.1505|4|||||N|N
CH|CH|MQM|Bilirubin (Total And Unbound) In The Neonate Test System|1||N|Y||862.1113|1|||||N|N
CH|CH|MRG|System, Test, Vitamin D|2||N|P||862.1825|1|||||N|N
CH|CH|MRR|System, Test, Low Density, Lipoprotein|1||N|N||862.1475|4|||||N|N
CH|CH|MRV|Drink, Glucose Tolerance|2||N|Y||862.1345|1|||||N|N
CH|CH|MSJ|Apolipoproteins|1||N|N||862.1475|4|||||N|N
CH|CH|MSM|System, Test, Lipoprotein(A)|1||N|N||862.1475|4|||||N|N
CH|CH|MYT|Biosensor, Immunoassay, Cpk Or Isoenzymes|2||N|P||862.1215|1|||||N|N
CH|CH|MZU|System,Test,Sodium,Enzymatic Method|2||N|Y||862.1665|1|||||N|N
CH|CH|MZV|Test,System,Potassium,Enzymatic Method|2||N|Y||862.1600|1|||||N|N
CH|CH|NAK|System,Test,Biotinidase|2||N|P||862.1118|1|||||N|N
CH|CH|NAL|Test,Immunoassay,Biosensor,Hcg|2||N|P||862.1155|1|||||N|N
CH|CH|NAO|Test,Carbohydrate Deficient Transferrin|1||N|N||862.1360|4|||||N|N
CH|CH|NAQ|Lipoprotein, High Density, Hdl, Over The Counter|1||N|N||862.1175|1|||||N|N
CH|CH|NBC|Test,Natriuretic Peptide|2||N|N||862.1117|1|||||N|N
CH|CH|NBW|System, Test, Blood Glucose, Over The Counter|2||N|N||862.1345|1|||||N|N
CH|CH|NDR|Enzyme Immunoassay, Inhibin-A|1||N|N||862.1260|4|||||N|N
CH|CH|NDY|Test, Cystatin C|2||N|N||862.1225|1|||||N|N
CH|CH|NEO|System, Test, Osteocalcin|2||N|N||862.1050|1|||||N|N
CH|CH|NHG|Enzyme Immunoassay, Cortisol, Salivary|2||N|P||862.1205|1|The HS Salivary Cortisol Enzyme Immunoassay Kit is for the quantitative in vitro diagnostic measurement of salivary cortisol.  This kit may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's Disease.  This kit is not intended for use with serum or plasma samples.  The device's intended use differs from the description in the classification regulation in that it is for use with saliva samples.||||N|N
CH|CH|NJV|Test, Albumin Cobalt Binding|2||N|N||862.1215|1|The Albumin Cobalt Binding Test is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with other tests such as ECG and cardiac troponin as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin.||||N|N
CH|CH|NQL|System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry|2||N|N||862.1055|1|Amino acids, free carnitines and acylcarnitines test system is intended for the measurement and evaluation of amino acid, free carnitine and acylcarnitine concentrations from newborn whole blood filter paper samples. The quantitative analysis of the amino acids, free carnitines and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that should aid in identifying elevated levels of these metabolites for screening newborns for one or more of several metabolic disorders.||||N|N
CH|CH|NQM|Immunoassay For Detection Of Amniotic Fluid Protein(S).|1||N|N||862.1550|4|The test is for use by health care professionals to aid in the detection of fetal membrane rupture in pregnant women, when they report signs, symptoms or complaints suggestive of such rupture.|cassette, dip stick or dipstrip|Immunoassay|: for testing cervicovaginal fluid specimens|N|N
CH|CH|NRH|System, Breath Measurement|1||N|N||862.1820|4|Breath measurement systems are used to measure constituents of exhaled breath as an aid in the diagnosis of sugar/nutrient malabsorbtion and other conditions.||||N|N
CH|CH|NSU|Instrumentation For Clinical Multiplex Test Systems|2||N|N||862.2570|1|Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample.  The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties.  The device may integrate scanning, reagent handling, hybridization, washing, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit.  This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature for de||||N|N
CH|CH|NVV|Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System|1||N|N||862.2100|4|Intended for clinical laboratory image storage and communications.  A clinical laboratory image storage and communications device is a device that provides electronic storage and retrieval functions, and provides electronic transfer for non-diagnostic clinical laboratory images. Images are not intended for diagnostic purposes and not intended for radiological images.|The clinical laboratory image storage and communications device is composed of the necessary hardware and software for digital image capture and storage.|Allows users to receive and store documents and non-diagnostic clinical laboratory digital images in a central repository or Laboratory Information System (LIS).  It will allow users to scan any document for storage or retrieval and may incorporate OCR indexing technology. The system allows users to capture clinical laboratory images from a variety of methods including digital cameras attached to a microscope; digital image imported from other media and may be linked to a patient record.|In Vitro|N|N
CH|CH|OAM|Immunoassay, Insulin-Like Growth Factor Binding Protein-1|1||N|N||862.1550|4|The device is a qualitative immunochromatographic test for the detection of amniotic fluid in cervicovaginal secretions.  The test is intended for professional use to help diagnose the rupture of fetal membranes in pregnant women.|The kit contains multiple test packs, each containing one sterile polyester swab for specimen collection, one tube of Specimen Extraction Solution, and one dipstick in a sealed aluminum foil pouch.|The test is based on immunochromatography.|Cervicovaginal specimens are collected and used on the device.|N|N
CH|CH|OHQ|Multi-Analyte Controls Unassayed|1||N|N||862.1660|4|A quality control material (unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (unassayed) for blood gases, electrolytes, enzymes, multianalytes, single (specified) analytes, or urinalysis controls.|quality control material|quality control material|in vitro diagnostic|N|N
CH|CH|OLD|Internal  Polymerase Chain Reaction  Control, Not Assay Specific|1||N|N||862.1660|4|Internal control that can be used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays.  It is not intended to monitor other real-time pcr processes.|It is a nonsense, non-specific deoxyribonucleic acid (DNA) sequence cloned into a plasmid vector and supplied in a tris ethylenediaminetetraacetic acid buffer.|The internal control template is a synthetic deoxyribonucleic acid (DNA) sequence that can be added to samples prior to nucleic acid extraction.  With the addition of specific primer and probe sets, it is then amplified along with the target DNA sequence during the real-time polymerase chain reaction (PCR) process.|It is for in vitro diagnostic tests.|N|N
CH|CH|OND|Osmolality Of Tears|1||N|N||862.1540|4|To measure the osmolality of human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.|Tear collection method and impendance measuring device.|Electrical impedance measurement to provide an indirect assessment of osmolality.|Eye|N|N
CH|CH|OOI|Real Time Nucleic Acid Amplification System|2||N|N||862.2570|1|The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system.|Should not include microarray or electrophoresis detection methods or instruments.|A real-time thermocycler is intended to identify and/or quantify the presence of specific sequences of double stranded DNA, amplified from a biological source and labeled with fluorescently labeled probes or through the use of intercalating dyes and detect using a high-power light-emitting diode (LED). Fluorescence emission is detected through the use of filters on a photodiode. The emission filters are optimized for use with specific fluorescent dyes.|N/A|N|N
CH|CH|OSX|Galectin-3 In Vitro Diagnostic Assay|2||N|N||862.1117|1|Galectin-3 is indicated for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.|in vitro diagnostic reagent kit|enzyme linked immunosorbent assay (ELISA)|in vitro diagnostic for use with serum and plasma|N|N
CH|CH|OTA|Mass Spectrometer For Clinical Multiplex Test Systems|2||N|N||862.2570|1|A mass spectrometer for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample.  The generated signals are produced by ionizing the compound or biological material under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass-to-charge ratios.  This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature.|mass spectrometer|Multiplex mass spectrometer. The device may integrate sample preprocessing/work station, liquid or gas chromatography, raw data storage mechanisms and other essential hardware and software components along with the basic modules of a mass spectrometry instrument.|IVD|N|N
CH|CH|OUL|Thermocycler, Generic|1||N|N||862.2310|4|A thermocycler is an automated laboratory apparatus intended to amplify specific segments of double stranded nucleic acids isolated from a clinical sample via the polymerase chain reaction process. The nucleic acid sequences are amplified in the presence of specific primers, buffers, and thermostable polymerases, by raising and lowering the thermal block temperature at specific rates using pre-programmed steps, based on the specifications of the test which is being run.  It may integrate interchangeable blocks of different materials or to accommodate different well and tube formats.|Should not include real-time thermocyclers or instruments with analyzers for fluorescence, other measuring techniques, or detection methods or integrate sample and/or reagent handling.|A thermocycler is intended amplify specific sequences of double stranded nucleic acids using the polymerase chain process. The device includes a thermal block with holes designed to accommodate the insertion of special tubes or plates holding the assay reaction mixtures and houses an internal computer-controlled, rapid heating/cooling unit. The thermal block¿s temperature is raised and lowered at specific rates using pre-programmed steps based on the specifications of the test which is being run.|Not applicable|N|N
CH|CH|OVA|Complete Gene Expression Profiling Accessory Reagents|2||N|N||862.2570|1|Complete gene expression profiling accessory reagent kits include all components necessary to perform transcript synthesis, fluorescent labeling, and detection and are intended to carry out all processing steps for separately cleared gene expression microarray assays which specify their use. They are designed and optimized for preparation of labeled complementary RNA (cRNA) target using total RNA isolated from specific clinical tissue specimens for hybridization to and measurement of fluorescently-labeled cRNA targets using a specified and cleared microarray instrumentation system. They may also include specified exogenous controls intended to monitor amplification and labeling processes.|Should not include reagents to perform only part of gene expression assay processing steps (e.g., transcript synthesis but not labeling) or only individual components insufficient to carry out all processing steps or only RNA extraction and purification from specific clinical specimens.  Should also not include reagents not intended for gene expression analysis, uncleared microarrays for gene expression, or cleared microarrays not specifying the reagent¿s use.|Complete accessory reagents for gene expression profiling are intended, designed, and optimized to carry out all assay processes.  The reagents include all components, including enzyme mixes, labeling reagents, reaction buffers, and purification reagents for the preparation, amplification, and specific labeling of cRNA targets from purified total RNA, isolated from specific tissue specimens, and the fragmentation and hybridization of the labeled-cRNA to microarrays for cleared microarray expression assays which specify their use.|Not applicable.|N|N
CH|CH|OYG|St2 Assay|2||N|N||862.1117|1|Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma.|test reagents|Quantitative sandwich monoclonal ELISA|In Vitro Diagnostics|N|N
CH|CH|OYJ|Dna Specimen Collection, Saliva|2||N|N||862.1675|1|A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing.|specimen collection device|Collects DNA in saliva and stabilizes it for transport or storage|clinical samples (saliva)|N|N
CH|CH|PCA|Dna Genetic Analyzer|2||N|N||862.2570|1|A genetic analyzer is an automated clinical multiplex instrument system intended to measure and sort signals generated by multiple fluorescent dyes in order to analyze DNA/RNA molecules in an assay from a clinical sample. Individual nucleotide sequences and DNA fragment sizes are identified using chain- or dye-termination or dye primer cycle sequencing, or PCR amplification with labeled primers, respectively. Labeled nucleotides and DNA fragments are separated by size and charge using a polymer-based separation matrix with capillary electrophoresis or other method. Fluorescence emissions are measured using filters on a photodiode or other detector and interpreted with software.|Should not include massively parallel or high-throughput sequencers or instruments with analyzers for fluorescence.|Utilizes denatured capillary electrophoresis by separating fluorescently labeled amplified DNA fragments or individual nucleotide bases by size and charge using a polymer-based separation matrix. It may integrate sample and/or reagent handling, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit.|N/A|N|N
CH|CH|PDJ|Hemoglobin A1c Test System|2||N|N||862.1373|1|Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.|In-Vitro Diagnostic Reagent Kit|Turbidimetric inhibition immunoassay|In-Vitro Diagnostic for use with Whole blood|N|N
CH|CH|PDS|Amniotic Fluid Protein Immunoassay|1||N|N||862.1550|1|To detect specified amniotic fluid proteins in cervicovaginal samples|dipstick or cassette|Detects specified amniotic fluid proteins|Cervicovaginal fluid samples|N|N
CH|CH|PEG|Nucleic Acid Quantitation Kit|1||N|N||862.2310|4|A nucleic acid quantitation kit consists of a nucleic acid stain (e.g., fluorescent, colorimetric, etc.) which is used to detect and quantitate small amounts of DNA, RNA, or oligonucleotides in solution by measuring the amount of fluorescence or absorbance at a specified wavelength.|The device consists of a complete reagent kit or accessory nucleic acid dye reagents intended to be used together.|A complete kit or accessory dye reagents which are intended and designed to bind to DNA (single- or double-stranded), RNA, or oligonucleotides depending upon the type of dye utilized.  The stained nucleic acid is measured using a spectrophotometer or fluorometer at a specified wavelength.|Nucleic acids|N|N
CH|CH|PER|Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis|1||N|N||862.2750|1|Flow cytometer specimen processors are automated or semi-automated workstations designed to be used alone or in combination with manual methods to pipette, dilute and process human specimens in preparation for flow cytometric analysis.|May include automated processing devices, pipetting devices, diluting devices.|Workstations prepare human specimens for flow cytometric analysis using an automated process to aspirate and dispense whole blood, lysing, stabilizing and fixative reagents, along with monoclonal antibodies and florescent molecules.|May include peripheral whole blood specimens, isolated mononuclear cells, bone marrow, body fluids and cells dispersed from tissues.|N|N
CH|CH|PFQ|Mmp-9 Test System|2||N|N||862.1540|1|A visual, qualitative immunoassay for the in vitro detection of elevated levels of the MMP-9 protein in tear fluid from patients suspected of having dry eye.|Tear collection method and single use immunoassay test cartridge|Immunoassay|Eyes|N|N
CH|CH|PHV|Continuous Glucose Monitor Retrospective Data Analysis Software|1||N|N||862.2120|4|Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device.|Software|data analysis system|Not Applicable|N|N
CH|CH|PIG|Acute Kidney Injury Test System|2||N|N||862.1220|1|An acute kidney injury test system is intended to measure one or more analytes in human samples as an aid in the assessment of a patient's risk for developing acute kidney injury.  Test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including conifmration by alternative methods.|The test system may include clinical analyzers, reagents, calibrators, and controls.|Assay to measure analyte(s) that are markers of Acute Kidney Injury|The test system is an in vitro diagnostic device that measures human samples.|N|N
CH|CH|PJC|Newborn Screening Specimen Collection Paper|2||N|N||862.1675|1|Newborn screening specimen collection paper is a blood collection device intended to be used as medium to collect and transport whole blood specimens from newborns to the laboratory for in vitro diagnostic analysis.|Newborn screening specimen collection paper is an in vitro diagnostic device that consists of specifically designed filter paper with a uniform surface for the collection of blood spots.   The collection paper is in the format of a printed card that incorporates a section for the collection of the patient¿s demographic information.|The blood is applied to the indicated spots on the paper.  The specimen is allowed to dry and then sent to a laboratory for in vitro diagnostic analysis.|An in vitro diagnostic device used as a medium to collect and transport whole blood specimen spots to a laboratory|N|N
CH|CH|PJD|Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device|2||N|N||862.1675|1|Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of  abuse or alcohol  testing.|Specimen collection device, which may include an absorbent oral fluid collection pad and/or a specimen storage container for collection, preservation and transport.|Collects oral fluid and stabilizes it for transport or storage.|clinical samples (oral fluid)|N|N
CH|CH|PJE|Blood/Plasma Collection Device For Dna Testing|2||N|N||862.1675|1|A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.|Blood collection device|The blood is drawn in the tube to be transported to the laboratory for clinical DNA testing.|Whole blood/ plasma for in vitro diagnostics|N|N
CH|CH|PJT|Continuous Glucose Monitor Secondary Display|2||N|N||862.1350|4|The purpose of the continuous glucose monitor secondary display is to notify another person, the follower, of the patient's continuous glucose monitoring system sensor glucose information in real time. The secondary display is intended for providing secondary notification of a continuous glucose monitoring system and does not replace primary real time continuous glucose monitoring or standard home blood glucose monitoring|Typically a software device installed on a third-party mobile device.|Receives and displays real-time patient data from a continuous glucose monitor.|n/a|N|N
CH|CH|PKU|Insulin Pump Secondary Display|2||N|N||862.1350|4|The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood glucose monitoring.|Typically a software device installed on a third-party mobile device, or implemented in a web-based platform.|Receives and displays real-time patient data from an insulin pump.|n/a|N|N
CH|CV|OJQ|Cardiac Allograft Gene Expression Profiling Test System|2||N|N||862.1163|1|In vitro diagnostic multivariate index assay (ivdmia) test service, performed in a single laboratory, for assessing the gene expression profile of rna isolated from peripheral blood mononuclear cells (pbmc) and indicated for use to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection (acr) at the time of testing in conjunction with standard clinical assessment.|laboratory based test|quantitative real-time polymerase chain reaction technology (qRT-PCR)|cardiac allograft|N|N
CH|HE|LPI|Kit, Assay, Progesterone Receptor|3||N|N||864.1860|2|||||N|N
CH|HE|LPJ|Kit, Assay, Estrogen Receptor|3||N|N||864.1860|2|||||N|N
CH|IM|JMG|Radioimmunoassay (Two-Site Solid Phase), Ferritin|2||N|P||866.5340|1|||||N|N
CH|MI|MXB|Test,Vaginal,Bacterial Sialidase|1||N|N||866.2660|4|||||N|N
CH|MI|OID|Sex Crimes/Sexual Assault/Suspect Evidence Collection Kit (Excludes Hive Testing)|1||N|N||866.2900|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CH|PA|MPQ|Container, Specimen, Urine, Drugs Of Abuse, Over The Counter|1||N|N||864.3260|4|||||N|N
CH|PA|MXT|Device, Accessory, Cooling Plate For Tissue Embedding Station|1||Y|N||864.3010|4|||||N|N
CH|PA|OHZ|Urine Transport Kit (Excludes Hiv Testing)|1||N|N||864.3250|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CH|PA|OIA|Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing)|1||N|N||864.3250|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CH|PA|OIB|Blood And Urine Collection Kit (Excludes Hiv Testing)|1||N|N||864.3250|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CH|PA|OIE|Urine Collection Kit (Excludes Hiv Testing)|1||N|N||864.3250|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CH|TX|MXA|System,Test,Breath Nitric Oxide|2||N|N||862.3080|1|||||N|N
CH|TX|OIC|Blood Alcohol Kit (Excludes Hiv Testing)|2||N|N||862.3040|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CH||JNW|Timed Flow In Capillary, Plasma Viscometry|U|1|N|N|||1|||||N|N
CH||LKV|Enzyme Immunoassay, Fetal Fibronectin|3||N|N|||2|||||N|N
CH||LTC|Hyaline Membrane Disease Assay|3||N|N|||3|||||N|N
CH||MDS|Sensor, Glucose, Invasive|3||N|N|||2|The device is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.||||N|N
CH||MWQ|System,Test,Total Antioxidant Status|3||N|N|||2|||||N|N
CH||NCT|Instrument, Glucose, Noninvasive Technology|3||N|N|||2|||||N|N
CH||NQC|Test, Breath Analysis, Volatile Organic Compounds|f||N|N|||6|Breath analysis test for use as an aid in the diagnosis of grade 3 heart transplant rejection in first year heart recipient patients||||N|N
CH||NUK|For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System|N|3|N|N|||3|||||N|N
CH||NUL|For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System|N|3|N|N|||3|||||N|N
CH||OTV|Research Use Only/Clinical Chemistry Devices|N|6|Y|N|||7|For research use only and for products imported into the US only.|N/A|N/A|N/A|N|N
CH||OYC|Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor|3||N|N|||2|The insulin pump is intended to be used as a component of an invasive glucose device.  The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor.|Must include product code MDS, sensor, glucose, invasive test system|The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor|see indications for use|N|N
CH||OZO|Artificial Pancreas Device System, Threshold Suspend|3||N|N|||2|An artificial pancreas system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels.|May include: Continuous glucose monitoring system, sensor, self monitoring blood glucose device, infusion pump, data management software|Uses a glucose monitoring system to measure glucose levels in interstitial fluid or blood and suspends or reduces insulin infusion from an insulin pump|Not meant to act on a specific part of the body but works with other devices - Continuous glucose monitoring system, sensor, self monitoring blood glucose device, data managment software|N|N
CH||OZP|Artificial Pancreas Device System, Single Hormonal Control|3||N|N|||2|An insulin-only artificial pancreas system that achieves a target glucose level by automatically increasing or reducing insulin infusion from an insulin pump. Insulin adjustments are based upon specified thresholds of measured glucose levels.|May include: Continuous glucose monitoring system, sensor, self monitoring blood glucose device, infusion pump, data management software|Uses a glucose monitoring system to measure glucose levels and increases or reduces insulin infusion from an insulin pump|Not meant to act on a specific part of the body but works with other devices - Continuous glucose monitoring system, sensor, self monitoring blood glucose device, data management software|N|N
CH||OZQ|Artificial Pancreas Device System, Bihormonal Control|3||N|N|||2|A bihormonal artificial pancreas system that achieves a target glucose level by automatically adjusting two glucose modulating therapies from an infusion pump. Hormone adjustments are based upon specified thresholds of measured glucose levels.|May include: Continuous glucose monitoring system, sensor, self monitoring blood glucose device, infusion pump, data management software|Uses a glucose monitoring system to measure glucose levels and increases or reduces two glucose modulating therapies from an insulin pump|Not meant to act on a specific part of the body but works with other devices - Continuous glucose monitoring system, sensor, self monitoring blood glucose device, data management software|N|N
CH||PAQ|Test, Nr2 Antibody|N|3|N|N|||3|NR2 is an independent blood-borne marker that rules in cerebral ischemic event and rules out hemorrhage.|Reagent test kit|Enzyme-linked immunosorbent assay (ELISA)|in vitro diagnostic device using human serum samples|N|N
CH||PAR|Test, Volatile Organic Compounds Breath Analysis|f||N|N|||6|Aid in the diagnosis of grade 3 heart transplant rejection in patients who have received heart transplants within the preceding year. Intended to be used as an adjunct to, and not as a substitute for, endomyocardial biopsy. The use of the device is limited to patients who have had endomyocardial biopsy within the previous month.|A breath collection apparatus for collection of volatile organic compounds in alveolar breath onto a sorbent trap, as well as for the collection of a separate sample of room air.    o	Analysis of the volatile organic compounds in alveolar breath and room air by gas chromatography and mass spectroscopy.    o	Interpretation of the volatile organic compounds with a proprietary algorithm in order to predict the probability of grade 3 heart transplant rejection.|Breathe collection device; analysis of the volatile organic compounds in alveolar breath and room air by gas chromatography and mass spectroscopy|Patients with heart transplants|N|N
CH||PDA|Investigational Use Only - Clinical Chemistry|N|6|Y|N|||7|Investigational use only and for products imported into the US only.|N/A|N/A|N/A|N|N
CH||PEJ|Salivary Estriol Test|3||N|N|||2|To detect and measure salivary estriol in pregnant women.|Pregnancy|Enzyme linked immunoabsorbent assay|saliva sample|N|N
CH||PHG|Droplet Digital Pcr System|N|3|N|N|||3|a digital polymerase chain reaction system intended to measure and sort multiple signals generated in an In Vitro Diagnostic assay from a clinical sample.  This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis|n/a|n/a|IVD|N|N
CH||PHK|Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation|N|9|N|N|||6|The test is a qualitative prognostic test intended to be used in patients less than 21 years old with liver or small bowel transplantation. The test is an aid in the evaluation of the risk of acute cellular rejection (ACR) and must be used in conjunction with biopsy, standard clinical assessment and other laboratory information.|flow cytometers, fluorochrome labeled antibodies, sodium heparin blood collection tubes, processing reagents, automated processing devices or pipetting devices.|Stimulated Cell Culture|Peripheral human whole blood specimens|N|N
CV|AN|OEV|Cardiopulmonary Resuscitation Aid Kit|2||N|N||868.5915|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|DPS|Electrocardiograph|2||N|Y|M|870.2340|1|||||N|N
CV|CV|DPT|Probe, Blood-Flow, Extravascular|2||N|P||870.2120|1|||||N|N
CV|CV|DPW|Flowmeter, Blood, Cardiovascular|2||N|P||870.2100|1|||||N|N
CV|CV|DQB|Phlebograph, Impedance|2||N|P||870.2750|1|||||N|N
CV|CV|DQC|Phonocardiograph|1||N|N||870.2390|4|||||N|N
CV|CV|DQD|Stethoscope, Electronic|2||N|P||870.1875|1|||||N|N
CV|CV|DQE|Catheter, Oximeter, Fiberoptic|2||N|P||870.1230|1|||||N|N
CV|CV|DQF|Actuator, Syringe, Injector Type|2||N|P||870.1670|1|||||N|N
CV|CV|DQG|Microsphere, Trace|3||N|N||870.1360|2|Call for PMAs 12/26/96 (61 FR 50706 (9/27/96))||||Y|N
CV|CV|DQH|Cardiograph, Apex (Vibrocardiograph)|2||N|P||870.2310|1|||||N|N
CV|CV|DQI|Withdrawal/Infusion Pump|2||N|P||870.1800|1|||||N|N
CV|CV|DQK|Computer, Diagnostic, Programmable|2||N|P||870.1425|1|||||N|N
CV|CV|DQO|Catheter, Intravascular, Diagnostic|2||N|P||870.1200|1|||||N|N
CV|CV|DQP|Kit, Balloon Repair, Catheter|3||N|N||870.1350|2|Call for PMAs 12/26/96 (61 FR 50706 (9/27/96))||||N|N
CV|CV|DQR|Cannula, Catheter|2||N|P||870.1300|1|||||N|N
CV|CV|DQT|Occluder, Catheter Tip|2||N|P||870.1370|1|||||N|N
CV|CV|DQX|Wire, Guide, Catheter|2||N|P||870.1330|1|||||N|N
CV|CV|DQY|Catheter, Percutaneous|2||N|P||870.1250|1|||||N|N
CV|CV|DRA|Catheter, Steerable|2||N|P||870.1280|1|||||N|N
CV|CV|DRB|Stylet, Catheter|2||N|P||870.1380|1|||||N|N
CV|CV|DRC|Trocar|2||N|P||870.1390|4|||||N|N
CV|CV|DRE|Dilator, Vessel, For Percutaneous Catheterization|2||N|P||870.1310|1|||||N|N
CV|CV|DRF|Catheter, Electrode Recording, Or Probe, Electrode Recording|2||N|N||870.1220|1|||||N|N
CV|CV|DRG|Transmitters And Receivers, Physiological Signal, Radiofrequency|2||N|P||870.2910|1|||||N|N
CV|CV|DRI|Monitor, Line Isolation|1||N|N||870.2620|4|||||N|N
CV|CV|DRJ|System, Signal Isolation|1||N|N||870.2600|4|||||N|N
CV|CV|DRK|Dc-Defibrillator, High Energy, (Including Paddles)|3||N|N||870.5300|2|PMA to be filed by 12/26/96 (FR 50706 (9/27/96))||||N|N
CV|CV|DRL|Tester, Defibrillator|2||N|P||870.5325|1|||||N|N
CV|CV|DRM|Compressor, Cardiac, External|3||N|N||870.5200|1|||||N|N
CV|CV|DRN|Device, Counter-Pulsating, External|2||N|N||870.5225|1|||||N|N
CV|CV|DRO|Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)|2||N|N||870.5550|1|||||N|Y
CV|CV|DRP|Tourniquet, Automatic Rotating|2||N|P||870.5925|1|||||N|N
CV|CV|DRQ|Amplifier And Signal Conditioner, Transducer Signal|2||N|P||870.2060|1|||||N|N
CV|CV|DRR|Amplifier And Signal Conditioner, Biopotential|2||N|P||870.2050|1|||||N|N
CV|CV|DRS|Transducer, Blood-Pressure, Extravascular|2||N|P||870.2850|1|||||N|N
CV|CV|DRT|Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)|2||N|Y|M|870.2300|1|||||N|N
CV|CV|DRW|Adaptor, Lead Switching, Electrocardiograph|2||N|Y|M|870.2350|1|||||N|N
CV|CV|DRX|Electrode, Electrocardiograph|2||N|Y|M|870.2360|4|||||N|N
CV|CV|DRY|Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass|2||N|P||870.4330|1|||||N|N
CV|CV|DRZ|Oscillometer|2||N|P||870.2675|4|||||N|N
CV|CV|DSA|Cable, Transducer And Electrode, Patient, (Including Connector)|2||N|P||870.2900|1|||||N|N
CV|CV|DSB|Plethysmograph, Impedance|2||N|P||870.2770|1|||||N|N
CV|CV|DSF|Recorder, Paper Chart|1||N|N||870.2810|4|||||N|N
CV|CV|DSH|Recorder, Magnetic Tape, Medical|2||N|P||870.2800|1|||||N|N
CV|CV|DSI|Detector And Alarm, Arrhythmia|2||N|N||870.1025|1|||||N|N
CV|CV|DSJ|Alarm, Blood-Pressure|2||N|P||870.1100|1|||||N|N
CV|CV|DSK|Computer, Blood-Pressure|2||N|P||870.1110|1|||||N|N
CV|CV|DSM|Alarm, Leakage Current, Portable|1||N|N||870.2640|4|||||N|N
CV|CV|DSP|System, Balloon, Intra-Aortic And Control|2||N|N||870.3535|1|||||N|N
CV|CV|DSR|Stimulator, Carotid Sinus Nerve|3||N|N||870.3850|2|Call for PMAs 12/26/96 (61 FR 50706 (9/27/96))||||Y|N
CV|CV|DSS|Clip, Vascular|2||N|N||870.3250|1|||||Y|N
CV|CV|DST|Clip, Vena-Cava|2||N|N||870.3260|1|||||Y|N
CV|CV|DSW|Bag, Polymeric Mesh, Pacemaker|1||N|N||870.3650|4|||||Y|N
CV|CV|DSY|Prosthesis, Vascular Graft, Of 6mm And Greater Diameter|2||N|N||870.3450|1|||||Y|N
CV|CV|DSZ|Pacemaker Battery|3||N|N||870.3610|2|||||Y|N
CV|CV|DTA|Tester, Pacemaker Electrode Function|2||N|P||870.3720|1|||||N|N
CV|CV|DTB|Permanent Pacemaker Electrode|3||N|N||870.3680|2|||||Y|N
CV|CV|DTC|Analyzer, Pacemaker Generator Function|2||N|P||870.3630|1|||||N|N
CV|CV|DTD|Pacemaker Lead Adaptor|2||N|N||870.3620|1|||||Y|N
CV|CV|DTE|Pulse-Generator, Pacemaker, External|3||N|N||870.3600|1|||||N|N
CV|CV|DTF|Tools, Pacemaker Service|1||N|N||870.3730|4|||||N|N
CV|CV|DTG|Magnet, Test, Pacemaker|1||N|N||870.3690|4|||||N|N
CV|CV|DTI|Sizer, Heart-Valve, Prosthesis|1||N|N||870.3945|4|||||N|N
CV|CV|DTJ|Holder, Heart-Valve, Prosthesis|1||N|N||870.3935|4|||||N|N
CV|CV|DTK|Filter, Intravascular, Cardiovascular|2||N|N||870.3375|1|||||Y|N
CV|CV|DTL|Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass|2||N|P||870.4290|4|||||N|N
CV|CV|DTM|Filter, Blood, Cardiopulmonary Bypass, Arterial Line|2||N|N||870.4260|1|||||N|Y
CV|CV|DTN|Reservoir, Blood, Cardiopulmonary Bypass|2||N|P||870.4400|1|||||N|N
CV|CV|DTP|Defoamer, Cardiopulmonary Bypass|2||N|N||870.4230|1|||||N|Y
CV|CV|DTQ|Console, Heart-Lung Machine, Cardiopulmonary Bypass|2||N|N||870.4220|1|||||N|Y
CV|CV|DTR|Heat-Exchanger, Cardiopulmonary Bypass|2||N|N||870.4240|1|||||N|Y
CV|CV|DTS|Sucker, Cardiotomy Return, Cardiopulmonary Bypass|2||N|P||870.4420|1|||||N|N
CV|CV|DTW|Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass|2||N|P||870.4340|1|||||N|N
CV|CV|DTX|Gas Control Unit, Cardiopulmonary Bypass|2||N|N||870.4300|1|||||N|Y
CV|CV|DTY|Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass|2||N|P||870.4410|1|||||N|N
CV|CV|DTZ|Oxygenator, Cardiopulmonary Bypass|2||N|N||870.4350|1|||||N|Y
CV|CV|DWA|Control, Pump Speed, Cardiopulmonary Bypass|2||N|N||870.4380|1|||||N|Y
CV|CV|DWB|Pump, Blood, Cardiopulmonary Bypass, Roller Type|2||N|N||870.4370|1|||||N|Y
CV|CV|DWC|Controller, Temperature, Cardiopulmonary Bypass|2||N|N||870.4250|1|||||N|Y
CV|CV|DWD|Suction Control, Intracardiac, Cardiopulmonary Bypass|2||N|P||870.4430|1|||||N|N
CV|CV|DWE|Tubing, Pump, Cardiopulmonary Bypass|2||N|P||870.4390|1|||||N|N
CV|CV|DWF|Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass|2||N|P||870.4210|1|||||N|N
CV|CV|DWJ|System, Thermal Regulating|2||N|P||870.5900|1|||||N|N
CV|CV|DWM|Apparatus, Suction, Patient Care|2||N|P||870.5050|1|||||N|N
CV|CV|DWP|Dilator, Vessel, Surgical|2||N|P||870.4475|1|||||N|N
CV|CV|DWQ|Stripper, Vein, External|2||N|P||870.4885|1|||||N|N
CV|CV|DWS|Instruments, Surgical, Cardiovascular|1||N|N||870.4500|4|||||N|N
CV|CV|DWX|Stripper, Artery, Intraluminal|2||N|P||870.4875|1|||||N|N
CV|CV|DWZ|Device, Biopsy, Endomyocardial|2||N|P||870.4075|1|||||N|N
CV|CV|DXC|Clamp, Vascular|2||N|P||870.4450|1|||||N|N
CV|CV|DXE|Catheter, Embolectomy|2||N|P||870.5150|1|||||N|N
CV|CV|DXF|Catheter, Septostomy|2||N|P||870.5175|1|||||N|N
CV|CV|DXG|Computer, Diagnostic, Pre-Programmed, Single-Function|2||N|P||870.1435|1|||||N|N
CV|CV|DXH|Transmitters And Receivers, Electrocardiograph, Telephone|2||N|P||870.2920|1|||||N|N
CV|CV|DXJ|Display, Cathode-Ray Tube, Medical|2||N|P||870.2450|1|||||N|N
CV|CV|DXK|Echocardiograph|2||N|Y|M|870.2330|1|||||N|N
CV|CV|DXL|Injector, Indicator|2||N|P||870.1660|1|||||N|N
CV|CV|DXM|Densitometer|2||N|P||870.1450|1|||||N|N
CV|CV|DXN|System, Measurement, Blood-Pressure, Non-Invasive|2||N|Y|M|870.1130|1|||||N|N
CV|CV|DXO|Transducer, Pressure, Catheter Tip|2||N|P||870.2870|1|||||N|N
CV|CV|DXP|Transducer, Vessel Occlusion|2||N|P||870.2890|1|||||N|N
CV|CV|DXQ|Blood Pressure Cuff|2||N|Y|M|870.1120|1|A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve(cuff) with a mechanism for inflating the bladder.  The cuff is used to determine a subject's blood pressure.||||N|N
CV|CV|DXR|Ballistocardiograph|2||N|P||870.2320|1|||||N|N
CV|CV|DXS|Gauge, Pressure, Coronary, Cardiopulmonary Bypass|2||N|P||870.4310|1|||||N|N
CV|CV|DXT|Injector And Syringe, Angiographic|2||N|P||870.1650|1|||||N|N
CV|CV|DXW|System, Phonocatheter, Intracavitary|2||N|P||870.1270|1|||||N|N
CV|CV|DXX|System, Catheter Control, Steerable|2||N|P||870.1290|1|||||N|N
CV|CV|DXY|Implantable Pacemaker Pulse-Generator|3||N|N||870.3610|2|||||Y|N
CV|CV|DXZ|Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene|2||N|N||870.3470|1|||||Y|N
CV|CV|DYB|Introducer, Catheter|2||N|P||870.1340|1|||||N|N
CV|CV|DYC|Vectorcardiograph|2||N|P||870.2400|1|||||N|N
CV|CV|DYE|Replacement Heart-Valve|3||N|N||870.3925|2|Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))||||Y|N
CV|CV|DYF|Prosthesis, Vascular Graft, Of Less Then 6mm Diameter|2||N|N||870.3450|1|||||Y|N
CV|CV|DYG|Catheter, Flow Directed|2||N|P||870.1240|1|||||N|N
CV|CV|IZQ|Injector, Contrast Medium, Automatic|2||N|P||870.1650|1|||||N|N
CV|CV|JOD|Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass|2||N|P||870.4270|1|||||N|N
CV|CV|JOM|Plethysmograph, Photoelectric, Pneumatic Or Hydraulic|2||N|P||870.2780|1|||||N|N
CV|CV|JON|Transducer, Apex Cardiographic|2||N|P||870.2840|1|||||N|N
CV|CV|JOO|Transducer, Heart Sound|2||N|P||870.2860|1|||||N|N
CV|CV|JOP|Transducer, Ultrasonic|2||N|Y|M|870.2880|1|||||N|N
CV|CV|JOQ|Generator, Pulse, Pacemaker, External Programmable|2||N|N||870.1750|1|||||N|Y
CV|CV|JOR|Generator, Pulsatile Flow, Cardiopulmonary Bypass|3||N|N||870.4320|2|Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976. Any other cardiopulmonary bypass pulsatile flow generator shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.||||N|N
CV|CV|JOW|Sleeve, Limb, Compressible|2||N|P||870.5800|1|||||N|N
CV|CV|KFJ|Materials, Repair Or Replacement, Pacemaker|3||N|N||870.3710|2|||||Y|N
CV|CV|KFM|Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type|3||N|N||870.4360|1|||||N|N
CV|CV|KRA|Catheter, Continuous Flush|2||N|P||870.1210|1|||||N|N
CV|CV|KRB|Probe, Thermodilution|2||N|P||870.1915|1|||||N|N
CV|CV|KRC|Tester, Electrode, Surface, Electrocardiographic|2||N|Y|M|870.2370|1|||||N|N
CV|CV|KRD|Device, Vascular, For Promoting Embolization|2||N|N||870.3300|1|||||Y|N
CV|CV|KRE|Analyzer, Pacemaker Generator Function, Indirect|2||N|P||870.3640|1|||||N|N
CV|CV|KRF|Charger, Pacemaker|1||N|N||870.3670|4|||||N|N
CV|CV|KRG|Programmer, Pacemaker|3||N|N||870.3700|2|||||N|N
CV|CV|KRH|Ring, Annuloplasty|2||N|N||870.3800|1|||||Y|N
CV|CV|KRI|Accessory Equipment, Cardiopulmonary Bypass|1||N|N||870.4200|4|||||N|N
CV|CV|KRJ|Filter, Prebypass, Cardiopulmonary Bypass|2||N|P||870.4280|1|||||N|N
CV|CV|KRK|Manometer, Blood-Pressure, Venous|2||N|P||870.1140|1|||||N|N
CV|CV|KRL|Detector, Bubble, Cardiopulmonary Bypass|2||N|P||870.4205|1|||||N|N
CV|CV|LDD|Dc-Defibrillator, Low-Energy, (Including Paddles)|2||N|N||870.5300|1|||||N|Y
CV|CV|LDE|Stethoscope, Manual|1||N|N||870.1875|4|||||N|N
CV|CV|LDF|Electrode, Pacemaker, Temporary|2||N|N||870.3680|1|||||N|Y
CV|CV|LIT|Catheter, Angioplasty, Peripheral, Transluminal|2||N|P||870.1250|1|||||N|N
CV|CV|LIX|Aid, Cardiopulmonary Resuscitation|3||N|N||870.5200|1|||||N|N
CV|CV|LOX|Catheters, Transluminal Coronary Angioplasty, Percutaneous|2||N|N||870.5100|1|A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.||||N|N
CV|CV|LXN|Probe, Test, Heart-Valve|1||N|N||870.4500|4|||||N|N
CV|CV|MAB|Marker, Cardiopulmonary Bypass (Vein Marker)|2||N|N||870.3450|1|||||N|N
CV|CV|MAL|Graft, Vascular, Synthetic/Biologic Composite|2||N|N||870.3450|1|||||Y|N
CV|CV|MAV|Syringe, Balloon Inflation|2||N|P||870.1650|1|||||N|N
CV|CV|MCW|Catheter, Peripheral, Atherectomy|2||N|P||870.4875|1|||||N|N
CV|CV|MFX|Vessel Guard Or Cover, To Facilitate Revision Surgeries|2||N|N||870.3470|1|Wrap, patch, or cover intended to protect vessels from injury during surgery, with the secondary function of facilitating revision surgeries by providing a plane of dissection.||||N|N
CV|CV|MGZ|Valvulotome|2||N|P||870.4885|1|||||N|N
CV|CV|MHX|Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)|2||N|N||870.1025|1|||||N|N
CV|CV|MJJ|Cpb Check Valve, Retrograde Flow, In-Line|2||N|P||870.4400|1|||||N|N
CV|CV|MJN|Catheter, Intravascular Occluding, Temporary|2||N|P||870.4450|1|||||N|N
CV|CV|MKJ|Automated External Defibrillators (Non-Wearable)|3||N|N||870.5310|2|This device is a non-wearable prescription use only aed.  These are devices that include automated external defibrillation.  Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation.  These devices are intended to be used on suspected victims of sudden cardiac arrest.  A person in cardiac arrest is unresponsive and is not breathing normally.  The device can be sold with prescription only.||||N|N
CV|CV|MLC|Monitor, St Segment|2||N|Y|M|870.2340|1|||||N|N
CV|CV|MLD|Monitor, St Segment With Alarm|2||N|N||870.1025|1|||||N|N
CV|CV|MLN|Electrode, Electrodcardiograph, Multi-Function|2||N|P||870.2360|4|||||N|N
CV|CV|MLO|Electrocardiograph, Ambulatory, With Analysis Algorithm|2||N|N||870.2800|1|||||N|N
CV|CV|MMX|Device, Percutaneous Retrieval|2||N|P||870.5150|1|||||N|N
CV|CV|MNJ|Valve, Pressure Relief, Cardiopulmonary Bypass|2||N|N||870.4400|1|||||N|N
CV|CV|MNW|Analyzer, Body Composition|2||N|P||870.2770|4|||||N|N
CV|CV|MOP|Rotator, Prosthetic Heart Valve|1||N|N||870.3935|1|||||Y|Y
CV|CV|MPC|Atrial Defibrillator|3||N|N||870.5300|2|Call for PMAs 12/26/96 (61 FR 50706 9/27/96))  Patients who are icd indicated and who have atrial tachyarrhythmias, or who are at risk of developing atrial tachyarrhythmias.||||Y|Y
CV|CV|MPD|Auxillary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator|2||N|N||870.5300|1|||||N|Y
CV|CV|MPE|Auxillary Power Supply (Ac Or Dc) For External Transcutaneous Cardiac Pacemaker|2||N|N||870.5550|1|||||N|Y
CV|CV|MSX|System,Network And Communication,Physiological Monitors|2||N|N||870.2300|1|||||N|Y
CV|CV|MTD|Catheter,Intracardiac Mapping,High-Density Array|2||N|N||870.1220|1|||||N|N
CV|CV|MUD|Oximeter, Tissue Saturation|2||N|N||870.2700|1|||||N|N
CV|CV|MWI|Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)|2||N|P||870.2300|1|||||N|N
CV|CV|MWJ|Electrocardiograph,Ambulatory(Without Analysis)|2||N|N||870.2800|1|||||N|N
CV|CV|MWS|Stabilizer,Heart|1||N|N||870.4500|4|||||N|N
CV|CV|MXC|Recorder,Event,Implantable Cardiac,(Without Arrhythmia Detection)|2||N|N||870.2800|1|||||Y|N
CV|CV|MXD|Recorder,Event,Implantable Cardiac,(With Arrhythmia Detection)|2||N|N||870.1025|1|||||Y|N
CV|CV|MZY|Graft,Vascular,Stainless Steel Tunneler|2||N|N||870.3450|4|||||N|N
CV|CV|NCP|Cannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism Protection|2||N|P||870.4210|1|||||N|N
CV|CV|NFA|Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection|2||N|N||870.1250|1|||||N|N
CV|CV|NHW|Electrode, Pacing And Cardioversion, Temporary, Epicardial|2||N|N||870.3680|1|The System is indicated for use in postoperative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion. Epicardial defibrillation electrodes can be implanted up to 7 days.||||N|Y
CV|CV|NKO|System, Balloon, Intra-Aortic And Control, Reprocessed|3||N|N||870.3535|1|Reprocessed Single Use Device (SUD) requiring 510(k) and previously exempt from submission of validation data.  As of 9/29/05 FR notice validation data is now required.  http://www.fda.gov/cdrh/reprocessing/fr-list2.html||||N|N
CV|CV|NKP|Injector, Contrast Medium, Automatic, Reprocessed|2||N|N||870.1650|1|||||N|N
CV|CV|NKQ|Guidewire, Catheter, Reprocessed|2||N|N||870.1330|1|||||N|N
CV|CV|NKR|System, Catheter Control, Reprocessed|2||N|N||870.1290|1|||||N|N
CV|CV|NKS|Catheter, Steerable, Reprocessed|2||N|N||870.1280|1|||||N|N
CV|CV|NKT|Injector And Syringe, Angiographic, Reprocessed|2||N|N||870.1650|1|||||N|N
CV|CV|NKU|Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed|2||N|N||870.1650|1|||||N|N
CV|CV|NKW|Actuator, Syringe, For Injector, Reprocessed|2||N|N||870.1670|1|||||N|N
CV|CV|NLG|Catheter, Mapping, Intracardiac, Reprocessed|2||N|N||870.1220|1|||||N|N
CV|CV|NLH|Catheter, Recording, Electrode, Reprocessed|2||N|N||870.1220|1|||||N|N
CV|CV|NLI|Catheter, Angiography, Reprocessed|2||N|N||870.1200|1|||||N|N
CV|CV|NLJ|Stripper, Vein, External, Reprocessed|2||N|N||870.4885|1|||||N|N
CV|CV|NMB|Catheter, Oximeter, Fiber Optic, Reprocessed|2||N|N||870.1230|1|||||N|N
CV|CV|NMD|Oximeter, Tissue Saturation, Reprocessed|2||N|N||870.2700|1|||||N|N
CV|CV|NMF|Clamp, Vascular, Reprocessed|2||N|P||870.4450|1|||||N|N
CV|CV|NMK|Trocar, Reprocessed|2||N|N||870.1390|1|||||N|N
CV|CV|NPP|Reprocessed Blood Pressure Cuff|2||N|N||870.1120|1|The intended use for the reprocessed/reused blood pressure cuff is use in manual measurement and automatic non-invasive blood pressure monitoring by properly trained personnel.  Complete inflation systems are designed for use with manometers during manual bp measurement.||||N|N
CV|CV|NQG|Stabilizer, Heart, Non-Compression, Reprocessed|1||N|N||870.4500|1|The device is used to stabilize, move, lift, and position the heart during cardiovascular surgery.||||N|N
CV|CV|NQH|Sensor, Pressure, Aneurysm, Implantable|2||N|N||870.2855|1|This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure.||||Y|N
CV|CV|NSA|Over-The-Counter Automated External Defibrillator|3||N|N||870.5310|1|Automated external defibrillators are devices that use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation.  These devices are intended to be used on suspected victims of sudden cardiac arrest.  A person in cardiac arrest is unresponsive and is not breathing normally.  The device can be sold over-the-counter without a prescription.  The device is to be used on adults and children who are either > 8 years old or > 55 lbs.||||N|Y
CV|CV|NTE|Temporary Carotid Catheter For Embolic Capture|2||N|N||870.1250|1|This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire.  The catheter has an embolic capture filter or an occlusion balloon at the distal end.  The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic material in a manner that may protect or prevent a stroke or other cerebral vascular sequelae.  The embolic capture device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures i||||N|N
CV|CV|NVM|Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon|2||N|N||870.1250|1|Percutaneous transluminal angioplasty of peripheral vasculature exclusive of coronary arteries|Comprised of a catheter body with two concentric distal inflatable balloons.|Used independently for dilation or dilatation of diseased peripheral vasculature to restore blood flow|Peripheral vasculature exclusive of coronary arteries.|N|N
CV|CV|NZE|Hyperthermia Monitor|2||N|N||870.5900|1|Intended to monitor and reduce a patient's temperature to mild hypothermia (not to go below 32 degrees celsius.  To induce mild hypothermia in hyperthermic patients¿ e.g., heat stroke, fever (excluding fever related to head injury, cardiac arrest, or other severe medical conditions).|Any application of external cooling methods (circulating water blankets/mattresses, circulating air blankets, cooling pads, cooling basins, etc.)|Any application of external cooling methods (circulating water blankets/mattresses, circulating air blankets, cooling pads, cooling basins, etc.)|entire body surface|N|N
CV|CV|OBI|Catheter, Pressure Monitoring, Cardiac|2||N|N||870.1200|1|To measure pressure within the cardiovascular system.|Catheter with sensors.|The catheter uses sensors which directly measure the pressure.|Cardiovascular system.|N|N
CV|CV|OBJ|Catheter, Ultrasound, Intravascular|2||N|N||870.1200|1|For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.|Catheter with ultrasound sensors that is used with an imaging system to display ultrasound image.|Catheter with ultrasound sensors that is used with an imaging system to display ultrasound image.|Cardiovascular anatomy and physiology.|N|N
CV|CV|OCH|Oximeter, Infrared, Sporting, Aviation|2||N|N||870.2700|7|Solely for use with sporting and aviation activities.  Intended to monitor heart rate during exercise.|sports watch that emits infrared|Non-invasive infrared|Circulatory pulse|N|N
CV|CV|OED|Antimicrobial Blood Pressure Cuff|2||N|N||870.1120|1|Device is a replacement cuff to be used in conjunction with a non-invasive blood pressure monitor.  Together the devices determine blood pressures and heart rate.  This particular cuff contains an embedded antimicrobial.  A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve(cuff) with a mechanism for inflating the bladder.  The cuff is used to determine a subject's blood pressure.|The device is a typically a textile enfolded over an inflatable bladder.|The blood pressure cuff wraps around the subject's arm or wrist and the bladder is inflated.  The pressure from the bladder occludes the artery.  When the pressure is slowly released, the Korotkoff sounds or oscillometric wave form produced is interpreted as sytolic and diastolic blood pressures.|The cuff is placed either over the upper arm, wrist, or thigh.|N|N
CV|CV|OEQ|Angiography/Angioplasty Kit|2||N|N||870.1650|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OER|Angioscopic Valvulotime Kit|2||N|N||870.1650|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OES|Cardiac Catheterization Kit|2||N|N||870.1200|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OET|Cardioplegia Solution Administration Kit|2||N|N||870.4240|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OEU|Cardiopulmonary Bypass Catheter Kit|2||N|N||870.4210|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OEX|Cadriovascular Catheter Sheath Introducer Kit|2||N|N||870.1340|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OEY|Single Lead Over-The-Counter Electrocardiograph|2||N|N||870.2340|1|Devices are intended to record and analyze single-lead electrocardiograms.  Devices only display interval values to the user.  Devices are intended for over-the-counter sale.  Devices are indicated for users who wish to monitor common ECG intervals.|Battery-operated, Plastic Case, Metal electrodes, Liquid Crystal Display|Records single-lead electrocardiogram through two or three electrodes.  Automatically analyzes waveform for common, clinically-accepted intervals.|heart|N|N
CV|CV|OEZ|Cardiovascular Procedure Kit|2||N|N||870.1200|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OFA|Cardiovascular Surgical Instruments Tray (Kit)|1||N|N||870.4500|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OFB|Catheter Guide Wire Kit|2||N|N||870.1330|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OFC|Catheter Introducer Kit|2||N|N||870.1340|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OFD|Catheter Introducer Kit|2||N|N||870.1340|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  The convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  The convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  The convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  The convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OFE|Central Venous Blood Pressure Kit|2||Y|N||870.1140|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OFF|Central Venous Catheter Tray (Kit)|2||N|N||870.1140|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OFG|Ct Biopsy Tray (Kit)|2||N|N||870.4075|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OFH|Digital Angiography Tray (Kit)|2||N|N||870.1650|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OFI|Laser Blood Flow Kit|2||N|N||870.2120|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OFJ|Lead Introducer Kit|2||N|N||870.1340|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OFK|Percutaneous Atrial Catheter Kit|2||N|N||870.1250|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OFL|Percutaneous Sheath Introducer Kit|2||N|N||870.1340|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OFM|Phlebotomy Blood Collection Kit|2||N|N||870.2750|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OFN|Winged Intravenous Catheterization Kit|2||N|N||870.1200|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV|CV|OGZ|Catheter, Intravascular, Plaque Morphology Evaluation|2||N|N||870.1200|1|Catheter used for delivery of a sensing modality to a coronary or peripheral artery region for determination of atherosclerotic plaque characteristics.  For examination of morphologic features of coronary or peripheral artery lesions or plaques.|Flexible intravascular catheter with plaque diagnostic modality at the tip.|The device is inserted into the arterial segment of interest, and using its sensing technology, obtains information on the characteristics of the arterial wall.  The characteristics are captured digitally and filtered with a software algorithm, and the arterial wall and lesion characteristics are presented to the user via a user interface.|Coronary or peripheral arteries.|N|N
CV|CV|OKR|Ventricular Bypass (Assist) Device|3||N|N||870.3545|2|A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow  for <6 hours. The device is either totally or partially implanted in the body.|A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for < 6 hours. The device is either totally or partially implanted in the body.|A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for < 6 hours. The device is either totally or partially implanted in the body.|A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for < 6 hours. The device is either totally or partially implanted in the body.|N|N
CV|CV|OMH|Pericardial Patch To Facilitate Revision Surgeries|2||N|N||870.3470|1|Pericardial patch or pledget with the secondary function of facilitating revision surgeries by providing a plane of dissection.  Does not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of cardiac surgery.|Sheet or film|Surgical implant|Cardiac structures|Y|Y
CV|CV|OMR|Vessel Guard Or Cover|2||N|N||870.3470|1|These device types do not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of vascular surgery.  Intended to protect vessels from injury during surgery (not to be confused with wraps, patches or covers intended to facilitate revision surgeries).  Indicated to wrap, patch, or cover intended to cover blood vessels.|a 2-dimensional material|The material is cut to size, then laid over a blood vessel and sutured/tacked into nearby tissue to keep it from migrating|over a blood vessel, typically the aorta during anterior vertebral surgery|Y|N
CV|CV|OMZ|Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter|2||N|N||870.1250|1|Catheter is used for Percutaneous Transluminal or balloon Valvuloplasty (PTV) of the pulmonary (pulmonic) valve.  Used on patients with isolated pulmonary stenosis and also on patients with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.|The device is a catheter with a balloon tip.|Catheter contains a ballon at the distal end of the shaft.  The catheter is inserted into the body and directed towards the pulmonary valve.  Once the catheter is placed in the valve, the balloon is expanded which compresses and/or breaks the material causing stenosis.|The target area is the pulmonary valve of the heart.|N|N
CV|CV|ORD|Optical Coherence Tomography, Intravascular Catheter|2||N|N||870.1200|1|For intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures.|A flexible intravascular catheter provides optical delivery and sensing of laser light to produce images of the vessel lumen and wall on its associated imaging system using optical coherence tomography technology.|A flexible intravascular catheter provides optical delivery and sensing of laser light to produce images of the vessel lumen and wall on its associated imaging system using optical coherence tomography technology.|Coronary vasculature|N|N
CV|CV|OTD|Endovascular Suturing System|2||N|N||870.3460|1|Provides fixation and sealing between and endovascular graft and the native artery.|The system is comprised of the implant device and an endovascular delivery device used to implant the endovascular suture.|Uses a metallic implant, delivered through a catheter-based system, to affix the material of an endovascular graft to native vessel|The implant is to be placed at the proximal end of an aortic aneurysm.|Y|N
CV|CV|OVJ|Pulse Generator, External Pacemaker, Dual-Chamber|3||N|N||870.3600|2|A dual chamber external pacemaker is intended to provide temporary dual chamber cardiac pacing as a substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats following cardiac surgery or a myocardial infarction.|A system generally includes the pulse generator, extension cables, and adaptors.  The pulse generator has a power supply and electronic components capable of data input, data output, and data processing.|The device is used with either an endocardial (transluminal) or epicardial cardiac pacing leads system to deliver a period electrical pulse which stimulates the heart.|This device is used in the right atrium and right ventricle only.|N|Y
CV|CV|OWQ|Reprocessed Intravascular Ultrasound Catheter|2||N|N||870.1200|1|For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.|Catheter with ultrasound sensors that is used with an imaging system to display ultrasound image.|Catheter with ultrasound sensors that is used with an imaging system to display ultrasound image.|Cardiovascular anatomy and physiology.|N|N
CV|CV|OZT|Balloon Aortic Valvuloplasty|2||N|N||870.1255|1|A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.|Generally, a balloon aortic valvuloplasty catheter is a coaxial catheter comprised of outer and inner layers. The catheter features a molded proximal end bifurcated with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polyamide. Upon reaching a specified pressure, the waist will expand to the rated balloon diameter and dilate the valve to the rated diameter.|The catheter is inserted into the body and directed towards the aortic valve. Once the catheter is placed in the valve, the balloon is expanded which compresses and/or breaks the material causing stenosis.|The aortic valve of the heart.|N|N
CV|CV|PAL|Pulmonic Replacement Heart Valve|f||N|N||870.3925|6|For open surgical replacement of malfunctioning pulmonic heart valve.|Animal tissue valve that has three leaflets and a ring of either tissue or fabric (called the sewing ring) that accepts sutures for sewing into the patient's annulus.|after being sewn into annulus, the leaflets open and close at appropriate periods in the heart beat cycle to control the flow of blood.|Sutured into the heart in the location where the native pulmonic valve used to reside (pulmonic valve annulus).|Y|Y
CV|CV|PBL|Temporary Cardiac Support Blood Pump|3||N|N||870.4360|1|Temporary circulatory support < 6 hours of use during off-pump bypass (OPCAB).|A catheter based axial flow impeller pump that is implanted within the heart.  the pump unloads the heart by actively pumping blood from the left veitricle to the aorta for durations of 6 hours or less.|The blood pump is used to support the circulation during surgical procedures (lasting < 6 hours) with or without the use of an oxygenator.|Intracardiac.|N|Y
CV|CV|PCK|Pediatric Ventricular Assist Device|f||N|N||870.3545|6|A ventricular assist device (VAD) assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body.|Ventricular assist devices may come in many shapes (depending on pulsatile or continuous flow, and mechanism of function) and sizes (depending on size of the patient). They utilize different functions to achieve replacement of the primary function of the ventricle. Generally, the pump itself has both plastic and metal components. Cannulae/catheters attaching to the ventricles and/or arteries are made of plastic. In addition to the pump, the system also generally has a driver where the pump function (speed, pressure, etc.) can be monitored and controlled.|Uses mechanical means to replace function of the left and/or right ventricles. For left ventricular support, blood is pumped from the left ventricle to the aortic arch. For right ventricular support, blood is pumped from the right ventricle to the pulmonary arteries.|Heart; Cardiovascular System|Y|Y
CV|CV|PDU|Catheter For Crossing Total Occlusions|2||N|N||870.1250|1|To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.|Peripheral catheter|Creates narrow channel in occlusion to allow for guidewire placement for further percutaneous intervention, such as angioplasty, atherectomy or stent placement.|Peripheral vasculature|N|N
CV|CV|PFA|Non-Invasive Central Venous Manometer|2||N|N||870.1140|1|Measures the central venous blood pressure (CVP) non-invasively at the superior vena cava (right heart) based on near infrared spectroscopy (NIRS) technology.|display unit, sensor cable, and adhesive sensor patches|Uses near infrared spectroscopy (NIRS) technology to measure blood flow between the neck location and the reference location|Applied to skin on neck to measure CVP|N|N
CV|CV|PFY|Low Patient Acuity Monitoring System|2||N|N||870.2300|1|For non-continuous central monitoring of patient parameters, including cardiac parameters, in low risk patients.|electronic software-driven monitor|Electronic display at a central monitoring station of monitoring data from patient sensors.|involves cardiac sensing and other sensor locations on the body|N|N
CV|CV|PJA|Coronary Vascular Physiologic Simulation Software|2||N|N||870.1415|1|A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.|Software|Performs offline analysis of pre-existing imaging data to simulate blood flow in the coronary vasculature.|Coronary Vasculature|N|N
CV|CV|PJB|Catheter Remote Control System|2||N|N||870.5700|1|A steerable cardiac ablation catheter remote control system is a device that is external to the body and interacts with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction, rotation, and deflection of a steerable ablation catheter used for the treatment of cardiac arrhythmias in the right side of the heart.  The device allows reversion to manual control of the steerable cardiac ablation catheter without withdrawal of the catheter and interruption of the procedure.|Consists of non-sterile, reusable components including the remote catheter system (sled, track, and turret), a hard-wired remote control, a bridge support with rail and frame, as well as a sterile, single use docking station and spreader to interface with compatible, commercially available ablation catheters.  Additional sterile, single-use accessory items (sterile cover and track kits) are used to maintain a sterile field during device use.|Uses electronic stepper motors to operate the manual handle of a steerable cardiac ablation catheter to remotely control its advancement, retraction, rotation, and deflection.  The system does not use software or decision logic to control the catheter and does not provide any diagnostic or visual information or therapy by itself.  Physicians use standard fluoroscopy to visualize the movement and placement of the catheter in the same way they would for a manual catheter procedure.  However, remote control of the catheter allows the physician the choice to be positioned outside of the fluoroscopy radiation field.|Right atrium|N|N
CV|CV|PLA|Esophageal Thermal Regulation And Gastric Suctioning Device|2||N|N||870.5910|1|The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage.|The device is a tube with three lumens made of standard medical-grade silicone. A connector allows the device to interface with an external controller, and another connector connects to wall suction.|The device is inserted into the esophagus, and is attached to an external controller that provides heated or cooled water, which flows in a closed loop through two lumens. A third central lumen connects to wall suction for gastric decompression/suctioning.|The device is inserted into the esophagus and the tip reaches the stomach. The entire body is affected by the temperature of the fluid flowing through the device.|N|N
CV|CV|PLB|Multivariate Vital Signs Index|2||N|N||870.2300|1|Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs.|software/firmware|Collects measured parameter inputs and automates the calculation of a summary index based on those parameters|Various|N|N
CV|GU|LYK|Angioscope|2||N|P||876.1500|1|||||N|N
CV|HO|OZW|Ingestible Event Marker|2||N|N||880.6305|1|To provide confirmation of an event co-ingested or coincident with the ingestible component of the device. The wearable component of the device incorporates wireless communication to display the event and other information on a general computing device|The system is composed of an ingestible microsensor, a data recorder in the form of a skin patch, and software|The grain-of-sand sized microsensor is designed to communicate the time-stamped confirmation of dosing as a unique identifier to the Proteus ingestion recorder worn on the skin. The ingestion signal is communicated via volume conduction communication also known as intra-body communication. The IEM is attached to an inert pharmaceutical excipient tablet for ease of handling and swallowability.|Digestive tract.|N|N
CV|SU|KPK|Marker, Ostia, Aorto-Saphenous Vein|2||N|N||878.4650|1|||||Y|N
CV|SU|MVR|Device,Anastomotic,Microvascular|2||N|N||878.4300|1|||||N|N
CV|SU|OCL|Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue|2||N|P||878.4400|1|Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue|The device tip delivers energy to provide cutting, coagulation, and/or ablation of the contacted tissue|The device energy source used to provide cutting, coagulation and/or ablation may be radio frequency (RF), cryogenic, laser or ultrasound|Cardiac tissue.|N|N
CV|SU|PAW|Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement|2||N|N||878.5035|1|To repair or replace chordae tendinae.|Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in repair or replacement of chordae tendinae. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).|provides tension between the papilary muscles and valve leaflets to prevent valve leaflet prolapse by restoring natural function of the chordae tendinae.|Mitral and Tricuspid valve apparatus.|Y|Y
CV||DSQ|Ventricular (Assisst) Bypass|3||N|N|||2|Approved pma:  P870072||||Y|N
CV||FZC|Prosthesis, Arterial Graft, Bovine Carotid Artery|3||N|N|||2|||||N|N
CV||LLK|Legging, Compression, Non-Inflatable|U|1|N|N|||1|||||N|N
CV||LOT|Pulse-Generator, Program Module|3||N|N|||2|||||N|N
CV||LOZ|Artificial Heart|3||N|N|||2|P030011||||Y|N
CV||LPA|System, Esophageal Pacing|3||N|N|||2|||||N|N
CV||LPB|Cardiac Ablation Percutaneous Catheter|3||N|N|||2|This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt).  This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae].||||N|N
CV||LPC|Device, Angioplasty, Laser, Coronary|3||N|N|||2|||||N|N
CV||LWO|Pulse-Generator, Single Chamber, Sensor Driven, Implantable|3||N|N|||2|||||Y|N
CV||LWP|Implantable Pulse Generator, Pacemaker (Non-Crt)|3||N|N|||2|These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.|These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.|These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.|These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.|Y|Y
CV||LWQ|Heart-Valve, Mechanical|3||N|N|||2|||||Y|Y
CV||LWR|Heart-Valve, Non-Allograft Tissue|3||N|N|||2|||||Y|N
CV||LWS|Implantable Cardioverter Defibrillator (Non-Crt)|3||N|N|||2|These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.|These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.|These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.|These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.|Y|Y
CV||LWT|Occluder, Balloon, Vena-Cava|3||N|N|||2|||||N|N
CV||LWW|Pulse-Generator, Single Chamber, Single|3||N|N|||2|||||N|N
CV||LWX|Device. Laser Peripheral Angioplasty|3||N|N|||2|||||N|N
CV||LWZ|Tissue Graft Of Less Than 6mm|3||N|N|||3|||||N|N
CV||LXA|Tissue Graft Of 6mm And Greater|3||N|N|||2|||||N|N
CV||MAD|Catheter, Percutaneous (Valvuloplasty)|3||N|N|||2|||||N|N
CV||MAE|Occluder, Patent Ductus, Arteriosus|3||N|N|||2|||||Y|N
CV||MAF|Stent, Coronary|3||N|N|||2|The formerly known device, Cardiovascular Stent, coded as "MAF" has been modified and is currently known and classified as a "Coronary Stent".  This device is a metal scaffold placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen.||||Y|N
CV||MCU|Cassette, Audio Tape|U|1|N|N|||1|||||N|N
CV||MCX|Catheter, Coronary, Atherectomy|3||N|N|||2|||||N|N
CV||MFA|Device, Removal, Pacemaker Electrode, Percutaneous|3||N|N|||2|||||N|N
CV||MFY|Kit, Cell Harvasting, Endothelial|2||N|N|||7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
CV||MGB|Device, Hemostasis, Vascular|3||N|N|||2|||||N|N
CV||MIE|Heart-Valve, Allograft|3||N|N|||3|||||Y|N
CV||MIH|System, Endovascular Graft, Aortic Aneurysm Treatment|3||N|N|||2|||||Y|N
CV||MIR|Shunt, Portosystemic, Endoprosthesis|3||N|N|||2|||||Y|N
CV||MLV|Transcatheter Septal Occluder|3||N|N|||2|Approved PMA:  P000039||||N|Y
CV||MNO|System, Laser, Transmyocardial Revascularization|3||N|N|||2|||||N|N
CV||MOM|System, Hemodynamic, Implantable|3||N|N|||2|||||Y|N
CV||MOU|Intravascular Radiation Delivery System|3||N|N|||2|||||N|N
CV||MOX|Batteries, Rechargeable, For Class 2 Devices|U|1|N|N|||1|||||N|N
CV||MOY|Batteries, Rechargeable, For Class 3 Devices|U|1|N|N|||1|||||N|N
CV||MRM|Defibrillator, Implantable, Dual-Chamber|3||N|N|||2|||||Y|Y
CV||MTE|System,Pacing,Temporary,Acute,Internal Atrial Defibrillation|3||N|N|||2|||||N|Y
CV||MUQ|Glue,Surgical,Arteries|3||N|N|||2|||||Y|Y
CV||MVK|Wearable Automated External Defibrillator|3||N|N|||2|The device is an automatic external defibrillator which monitors and treats a patient for ventricular defibrillation.  Device is intended to be worn in home or in hospital settings as prescribed and overseen by a physician.||||N|Y
CV||MWH|Pulmonic Valved Conduit|f||N|N|||6|||||Y|Y
CV||NAP|Cardiac Support Mesh Wrap|N|3|N|N|||3|The device is a passive mesh wrap that is placed around both ventricles of the heart; The intention is to inhibit further dilatation of the ventricles and thus to facilitate reverse remodeling of the myocardium.  The device is indicated for use in adult patients diagnosed with dilated cardiomyopathy who are symptomatic in spite of optimal medical therapy. The device can be used alone or in conjunction with mitral valve repair or replacement, if the later therapy is judged appropriate.|The device is a passive mesh wrap that is placed around both ventricles of the heart; the intention is to inhibit further dilatation of the ventricles and thus to facilitate reverse remodeling of the myocardium.  The device is indicated for use in adult patients diagnosed with dilated cardiomyopathy who are symptomatic in spite of optimal medical therapy. The device can be used alone or in conjunction with mitral valve repair or replacement, if the later therapy is judged appropriate.|The device is a passive mesh wrap that is placed around both ventricles of the heart; the intention is to inhibit further dilatation of the ventricles and thus to facilitate reverse remodeling of the myocardium.  The device is indicated for use in adult patients diagnosed with dilated cardiomyopathy who are symptomatic in spite of optimal medical therapy. The device can be used alone or in conjunction with mitral valve repair or replacement, if the later therapy is judged appropriate.|Heart|Y|N
CV||NAV|Graft,Bypass,Coronary Artery|f||N|N|||6|||||Y|Y
CV||NGV|System, Appendage Closure, Left Atrial|N|3|N|N|||2|||||Y|N
CV||NIK|Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)|3||N|N|||2|These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.|These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.|These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.|These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.|Y|Y
CV||NIM|Stent, Carotid|3||N|N|||2|Stent, Carotid -- a metal scaffold placed via a delivery catheter into the carotid artery to maintain the lumen||||Y|Y
CV||NIN|Stent, Renal|3||N|N|||2|Stent, Renal -- a metal scaffold placed via a delivery catheter into the renal artery to maintain the lumen||||Y|Y
CV||NIO|Stent, Iliac|3||N|N|||2|Stent, Iliac -- a metal scaffold placed via a delivery catheter into the iliac artery to maintain the lumen||||Y|Y
CV||NIP|Stent, Superficial Femoral Artery|3||N|N|||2|Stent, Superficial Femoral Artery -- a metal scaffold placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen||||Y|Y
CV||NIQ|Coronary Drug-Eluting Stent|3||N|N|||2|Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen.  The drug coating is intended to inhibit restenosis.||||Y|Y
CV||NIU|Stent, Superficial Femoral Artery, Drug-Eluting|3||N|N|||2|Stent, Superficial Femoral Artery, Drug-Eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen.  The drug coating is intended to inhibit restenosis.||||Y|Y
CV||NIV|Coronary Covered Stent|f||N|N|||6|Stent, coronary, covered -- a metal scaffold covered with material placed via a delivery catheter into the coronary artery artery or saphenous vein graft for the treatment of free perforations and/or to prevent dislodgement into the circulation of biological material from the vascular wall during or following placement of the device.||||Y|Y
CV||NKE|Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)|3||N|N|||2|These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure.|These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure.|These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure.|These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure.|Y|Y
CV||NKM|Mitral Valve Repair Devices|3||N|N|||2|To repair the mitral valve by coapting the valve leaflets to prevent mitral regurgitation.  These devices are different from the classified device (annuloplasty rings) in that a cardiotomy is not required to place them, some of them are placed percutaneously, and they definitely are not rings that are sewn on to the valve annulus.||||Y|N
CV||NMM|Catheter, Angioplasty, Peripheral, Transluminal, Reprocessed|U|1|N|N|||1|||||N|N
CV||NPT|Aortic Valve, Prosthesis, Percutaneously Delivered|3||N|N|||2|To replace a patient's aortic heart valve.  They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.||||Y|Y
CV||NPV|Pulmonary Valve Prosthesis Percutaneously Delivered|f||N|N|||2|These devices are intended to replace a patient's pulmonary heart valve.  They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.||||Y|Y
CV||NVN|Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes|3||N|N|||2|Drug eluting permanent RV or RA pacemaker electrodes are used with compatible  pacemakers or implantable cardioverter defibrillators (ICD) or cardiac rhythm therapy (CRT) devices to deliver pacing pulses to the heart.|The device is a flexible, insulated electrical conductor with one end designed to make a secure connection to a pacemaker or ICD or CRT and the other end applied to the myocardium.|Used as part of an implantable pacemaker system.|Makes contact with the heart (myocardial tissue).|Y|Y
CV||NVY|Permanent Defibrillator Electrodes|3||N|N|||2|Permanent defibrillator electrodes are used with compatible implantable cardioverter defibrillators (ICD) and cardiac rhythm therapy-defibrillators (CRT-D) to sense the cardiac rhythm and to deliver high energy therapy to the heart when tachycardia is detected.  Some transvenous models can also be used for pacing the right ventricle.|The device is a flexible, insulated electrical conductor with one end designed to make a secure connection to an ICD or CRT-D and the other end located in a position which directs defibrillation energy to the heart|Used as part of an implantable defibrillation system.|Makes contact with the heart (endocardial or myocardial tissue) or is located in a proximity and orientation that creates a vector for defibrillation energy to the heart.|Y|Y
CV||NVZ|Pulse Generator, Permanent, Implantable|3||N|N|||2|Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart.|A hermetically sealed outer can (usually metallic) houses electronic circuitry and allows for connection to pacing leads (electrodes).|Used as part of a pacing system that consists of a pulse generator and a lead, and which may also require an external pacemaker programmer.|Implanted in the chest or abdomen, and makes contact with cardiac tissue via pacing leads.|Y|Y
CV||NWX|Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring|3||N|N|||2|To reduce coronary artery stenosis by dilatation of the balloon and by apposition of the cutting/scoring surfaces to the stenotic material for the treatment of coronary artery stenosis to improve myocardial perfusion.|Cutting/scoring PTCA catheters are usually comprised of flexible polymers for the catheter body and a compliant polymer for the balloon.  The cutting/scoring elements are usually metal.|The device functions independently, but is typically placed using a guidewire and guiding catheter.  The balloon is inflated by the infusion of liquid through the body of the catheter.  Following treatment, the liquid is withdrawn, the balloon is deflated and then withdrawn from the body.|Coronary arteries.|N|N
CV||OAD|Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter|3||N|N|||2|For the treatment of atrial flutter.|The device is an ablation catheter that features electrodes through which thermal energy is delivered.|The ablation catheter delivers energy to the specific region of the heart in order to create lesions that will treat the patient of atrial flutter.|Heart|N|Y
CV||OAE|Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation|3||N|N|||2|For the treatment of atrial fibrillation.|The device is an ablation catheter that features electrodes through which thermal energy is delivered.|The ablation catheter delivers energy to the specific region of the heart in order to create lesions that will treat the patient of atrial fibrillation.|Heart|N|Y
CV||OBC|Occluder, Internal Vessel, Temporary|3||N|N|||2|For temporarily occluding vessels during anastomosis procedures.|liquid at room temperature and gel at body temperature|The material is thermosensitive such that it forms a gel when injected into the blood vessel, and remains gelled for the period it takes to make the anastomosis|blood vessels|N|N
CV||OBD|Barrier, Adhesion, Cardiovascular|3||N|N|||2|Indicated to reduce the incidence, severity or extent of adhesions/tissue attachment in cardiovascular surgery by providing a plane of dissection or mechanical barrier between opposing surfaces of tissue and/or devices.  Intended for use in cardiac surgery to prevent or reduce adhesions, and facilitate reoperation in patients who are anticipated to need staged cardiovascular surgeries or repeat procedures in the thoracic region.|a resorbable synthetic polymeric material that is either a sheet of material or a spray liquid|the barrier may be either placed in the area of concern, or sutured in place, or sprayed onto the area|thoracic region|Y|N
CV||OCM|Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation|3||N|N|||2|Surgical cardiac ablation for the treatment of atrial fibrillation.|x|x|Heart.|N|N
CV||ODT|Tissue Adhesive, Aortic Aneurysmorrhaphy|f||N|N|||6|For use as an adjunct in the surgical repair of thoracic aortic aneurysms.|a two-part liquid that is mixed just prior to use|the adhesive is introduced into the false lumen after collapsing the false lumen to minimize the amount of adhesive needing to be dispensed|false lumen of an aortic aneurysm|Y|N
CV||OHA|Heart Valve, More Than Minimally Manipulated Allograft|U|1|N|N|||1|For the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary heart valves.  They may also be used in the replacement of native pulmonary heart valves when the ross procedure is performed.  Pulmonary heart valve allografts are used to repair both congential and acquired valvular lesions.|The allograft heart valve has been more than minimally manipulated.|The allograft heart valve replaces the native or prosthetic pulmonary heart valve.|pulmonary heart valve|Y|N
CV||OJE|Right Ventricular Bypass (Assist) Device|f||N|N|||6|To provide circulatory support for patients in cardiogenic shock due to acute right ventricular failure.|The system is comprised of a blood pump, motor, drive console, flow sensor, and inlet and outlet cannulae.  The blood pump is single-use only but the other components can be reused.|The blood pump is driven by a motor and controller, to propel blood from the right ventricle or atrium to the pulmonary circulation.|right ventricle or atrium to pulmonary circulation|N|N
CV||OJX|Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode|3||N|N|||2|Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart.|The device is a flexible, insulated electrical conductor with one end designed to make a secure connection to a CRT device and the other end located in a left cardiac vein.|Used as part of an implantable crt system.|Makes contact with the lv via the left cardiac vein.|Y|Y
CV||ONU|Drug-Eluting Peripheral Transluminal Angioplasty Catheter|3||N|N|||2|A Drug-Eluting Peripheral Transluminal Angioplasty Catheter is a combination product intended for balloon dilatation of peripheral vasculature to establish or maintain patency.  A drug-eluting PTA catheter delivers a drug to the vessel as part of the angioplasty procedure and is intended to inhibit restenosis.  Intended to provide Percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, popliteal, infrapopliteal, femoral, and iliofemoral, as well as native or synthetic arteriovenous dialysis fistulae.|The balloon catheter is generally constructed of synthetic materials such as plastic and introduced into the body using a guidewire.  The balloon is generally manufactured in multiple diameters and lengths to allow for treatment of different lesion sizes.|The balloon catheter uses mechanical force across a lesion to establish patency.  The drug coating serves as an adjunct to the mechanical action of balloon angioplasty and assists in maintaining vessel patency post-procedure.|lesions in peripheral arteries including iliac, popliteal, infrapopliteal, femoral, and iliofemoral, as well as native or synthetic arteriovenous dialysis fistulae|N|N
CV||OSR|Pacemaker/Icd/Crt Non-Implanted Components|3||N|N|||2|Pacemaker/ICD/CRT non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider.|Pacemaker/ICD/CRT non-implanted components can be separate pieces or integrated and usually include housings, electronics, processors, software, connectors, and cables.|Pacemaker/ICD/CRT non-implanted components transmit data from the implanted device to the health care provider using telemetry download, and direct or remote transmission.|Pacemaker/ICD/CRT devices are intended to provide therapy to the heart.  The non-implanted components support the implanted devices.|Y|N
CV||OZD|Temporary Non-Roller Type Cardiac Support Blood Pump|3||N|N|||2|A blood pump that provides temporary full or partial cardiac/ventricular support as an adjunctive therapy for patients considered high risk for cardiac procedures|Rotor or axial type pump manufactured of various materials.  Single use, disposable.|pumps part or all of the patient's blood circulation either during an adjunctive procedure where the patient requires hemodynamic stability, or a temporary use of the device to unload the heart to give it time to recover from an acute condition.|Heart|N|Y
CV||OZG|Transcatheter Septal Occluder (Atrial)|3||N|N|||2|For the treatment of defects in the atrial septum and closure of atrial septal defects via transcatheter technique.|permanent implant placed in septum (usually constructed of a combination of metals/polymers that is placed via a venous catheter system)|percutaneous venous puncture and interventional technique|cardiac atrial septum|Y|N
CV||OZH|Transcatheter Septal Occluder (Ventricular)|3||N|N|||2|For the treatment of defect in the ventricular septum and closure of ventricular septal defects via transcatheter technique.|permanent implant placed in septum, usually constructed of a combination of metals/polymers that is placed via a catheter system|percutaneous puncture and interventional technique|cardiac ventricular septum|Y|N
CV||PAP|Aortic Heart Valve, More Than Minimally Manipulated Allograft|f||N|N|||6|Intended for use in the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic aortic valves in pediatric patients.|More than minimally manipulated aortic allograft heart valve|Surgical replacement|Aortic valve|Y|Y
CV||PCW|Implantable Pulse Generator, Programmer And Battery Charger|N|3|N|N|||7|intended for the treatment of moderate to severe heart failure.|resembles an implantable cardiac pacemaker, it differs in that it devlivers it electrical stimulation pulses during the absolute refractory period and therefore does not initiate a cardiac cycle, thus it does not regulate rhythmicity|electricallly stimulates the heart during the absolute refractory period to improve cardiac contractile properties|apllies electrical pulses to the heart|Y|N
CV||PCX|Artificial Chordae Tendinae Delivery System|N|3|N|N|||3|Deploys commercially available ePTFE suture, labeled for use as artificial chordae tendinae, while the heart is beating as an alternative to the conventional surgical approach for this type of mitral valve repair.|hand-held dispenser|manual dispenser|cardiovascular system|N|N
CV||PFV|System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment|3||N|N|||2|An endovascular graft for AV dialysis access is a stent graft intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access (treat stenotic lesions or thromboic occlusions) for hemodialysis.|The endovascular stent-graft is a metal scaffold covered with fabric material.  The stent-graft is placed via a delivery catheter into the arteriovenous dialysis access circuit to maintain or re-establish vessel patency for hemodialysis.  The endovascular stent-grafts are available in various diameters and lengths.|Generally, a Peripheral Transluminal Angioplasty (PTA) catheter is used initially to open up the occlusion and allow for passage of the endovascular graft delivery system to pass through.  The endovascular graft is then deployed at the site of the occlusion with the structural stent component propping open the vessel.  The covered stent assists in maintaining vessel patency post-procedure.|Stenotic lesions or thrombotic occlusions in the arteriovenous dialysis access circuit, including the venous anastomosis.|Y|N
CV||PIZ|Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve|3||N|N|||2|Intended for use as a CPR adjunct to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest.|The device system is comprised of two components:  A manual pump containing a suction cup so that active decompression can take place.  The valve is inserted in the respiratory circuit (e.g., facemask or advanced airway) during CPR.|Uses active compression and decompression of the victim's chest during manual CPR, as well as impeding the inflow of air during the decompression phase to reduce the intrathoracic pressure and increase blood flow.|The pump is placed on the victim's chest, and the valve is placed within the respiratory circuit.|N|Y
CV||PJQ|Agent, Occluding, Vascular, Permanent|3||N|N|||2|The device is a polymerizing agent intended for permanent occlusion of peripheral blood vessels.|The device consists of a polymerizing glue and delivery system for injection into the vasculature.|The material polymerizes in the vessel to permanently coapt or occlude the vessel.|Peripheral vasculature|Y|N
CV||PKK|Stent Delivery System|N|3|N|N|||7|for coarctation of the aorta|for coarctation of the aorta|for coarctation of the aorta|Aorta|Y|N
DE|DE|DYH|Adhesive, Bracket And Tooth Conditioner, Resin|2||N|P||872.3750|1|||||N|N
DE|DE|DYJ|Retainer, Screw Expansion, Orthodontic|1||N|N||872.5410|4|||||N|N
DE|DE|DYN|Mouthpiece, Saliva Ejector|1||N|Y|M|872.6640|4|||||N|N
DE|DE|DYO|Band, Material, Orthodontic|1||N|N||872.5410|4|||||N|N
DE|DE|DYT|Maintainer, Space Preformed, Orthodontic|1||N|N||872.5525|4|||||N|N
DE|DE|DYW|Bracket, Plastic, Orthodontic|2||N|P||872.5470|1|||||N|N
DE|DE|DYX|Lock, Wire, And Ligature, Intraoral|2||N|N||872.4600|1|||||Y|N
DE|DE|DZA|Drill, Dental, Intraoral|1||N|N||872.4130|4|||||N|N
DE|DE|DZB|Headgear, Extraoral, Orthodontic|2||N|P||872.5500|1|||||N|N
DE|DE|DZC|Wire, Orthodontic|1||N|N||872.5410|4|||||N|N
DE|DE|DZD|Tube, Orthodontic|1||N|N||872.5410|4|||||N|N
DE|DE|DZE|Implant, Endosseous, Root-Form|2||N|N||872.3640|1|||||Y|N
DE|DE|DZH|Saw, Bone, Ac-Powered|2||N|P||872.4120|1|||||N|N
DE|DE|DZI|Drill, Bone, Powered|2||N|P||872.4120|1|||||N|N
DE|DE|DZJ|Driver, Wire, And Bone Drill, Manual|2||N|P||872.4120|1|||||N|N
DE|DE|DZK|Wire, Fixation, Intraosseous|2||N|N||872.4880|1|||||Y|N
DE|DE|DZL|Screw, Fixation, Intraosseous|2||N|N||872.4880|1|||||Y|N
DE|DE|DZM|Needle, Dental|1||N|N||872.4730|4|||||N|N
DE|DE|DZN|Instruments, Dental Hand|1||N|N||872.4565|4|||||N|N
DE|DE|DZP|Instrument, Diamond, Dental|1||N|N||872.4535|4|||||N|N
DE|DE|DZS|Capsule, Dental, Amalgam|1||N|N||872.3110|4|||||N|N
DE|DE|EAQ|Detector, Ultraviolet|2||N|P||872.6350|1|||||N|N
DE|DE|EAS|Gel, Electrode, For Pulp Tester|1||N|N||872.1730|4|||||N|N
DE|DE|EAT|Tester, Pulp|2||N|P||872.1720|4|||||N|N
DE|DE|EAX|Mirror, Mouth|1||N|N||872.4565|4|||||N|N
DE|DE|EAY|Light, Fiber Optic, Dental|1||N|N||872.4620|4|||||N|N
DE|DE|EAZ|Light, Operating, Dental|1||N|N||872.4630|4|||||N|N
DE|DE|EBA|Light, Surgical Headlight|1||N|N||872.4630|4|||||N|N
DE|DE|EBC|Sealant, Pit And Fissure, And Conditioner|2||N|P||872.3765|1|||||N|N
DE|DE|EBD|Coating, Filling Material, Resin|2||N|P||872.3310|1|||||N|N
DE|DE|EBE|Coating, Denture Hydrophilic, Resin|2||N|P||872.3300|1|||||N|N
DE|DE|EBF|Material, Tooth Shade, Resin|2||N|Y|M|872.3690|1|||||N|N
DE|DE|EBG|Crown And Bridge, Temporary, Resin|2||N|P||872.3770|1|||||N|N
DE|DE|EBH|Material, Impression Tray, Resin|1||Y|N||872.3670|4|||||N|N
DE|DE|EBI|Resin, Denture, Relining, Repairing, Rebasing|2||N|P||872.3760|1|||||N|N
DE|DE|EBL|Pin, Retentive And Splinting, And Accessory Instruments|1||N|N||872.3740|4|||||N|N
DE|DE|EBO|Over The Counter Denture Repair Kit|2||N|P||872.3570|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
DE|DE|EBP|Reliner, Denture, Over The Counter|2||N|P||872.3560|4|||||N|N
DE|DE|EBR|Unit, Suction Operatory|1||N|Y|M|872.6640|4|||||N|N
DE|DE|EBW|Controller, Foot, Handpiece And Cord|1||N|Y|M|872.4200|1|||||N|N
DE|DE|EBZ|Activator, Ultraviolet, For Polymerization|2||N|P||872.6070|1|||||N|N
DE|DE|ECB|Unit, Syringe, Air And/Or Water|1||N|N||872.4565|4|||||N|N
DE|DE|ECC|Sterilizer, Glass Bead|3||N|N||872.6730|2|Call for PMAs on 4/21/97 per 62 FR 2902 on 1/27/97||||N|N
DE|DE|ECG|Sterilizer, Boiling Water|1||N|Y|M|872.6710|1|||||N|N
DE|DE|ECI|Band, Elastic, Orthodontic|1||N|N||872.5410|4|||||N|N
DE|DE|ECM|Band, Preformed, Orthodontic|1||N|N||872.5410|4|||||N|N
DE|DE|ECN|Clamp, Wire, Orthodontic|1||N|N||872.5410|4|||||N|N
DE|DE|ECO|Spring, Orthodontic|1||N|N||872.5410|4|||||N|N
DE|DE|ECP|Instrument, Ligature Tucking, Orthodontic|1||N|N||872.4565|4|||||N|N
DE|DE|ECQ|Aligner, Bracket, Orthodontic|1||N|N||872.4565|4|||||N|N
DE|DE|ECR|Setter, Band, Orthodontic|1||N|N||872.4565|4|||||N|N
DE|DE|ECS|Pusher, Band, Orthodontic|1||N|N||872.4565|4|||||N|N
DE|DE|ECT|Driver, Band, Orthodontic|1||N|N||872.4565|4|||||N|N
DE|DE|EEA|Plate, Base, Shellac|1||Y|N||872.6200|4|||||N|N
DE|DE|EEF|Clamp, Rubber Dam|1||Y|N||872.6300|4|||||N|N
DE|DE|EEG|Heat Source For Bleaching Teeth|1||N|N||872.6475|4|||||N|N
DE|DE|EEJ|Guard, Disk|1||Y|N||872.6010|4|||||N|N
DE|DE|EFA|Handpiece, Belt And/Or Gear Driven, Dental|1||N|Y|M|872.4200|1|||||N|N
DE|DE|EFB|Handpiece, Air-Powered, Dental|1||N|Y|M|872.4200|1|||||N|N
DE|DE|EFC|Warmer, Anesthetic Tube|1||N|N||872.6100|4|||||N|N
DE|DE|EFD|Amalgamator, Dental, Ac-Powered|1||N|N||872.3100|4|||||N|N
DE|DE|EFH|Paper, Articulation|1||Y|N||872.6140|4|||||N|N
DE|DE|EFK|Forceps, Articulation Paper|1||N|N||872.4565|4|||||N|N
DE|DE|EFL|Forceps, Dressing, Dental|1||N|N||872.4565|4|||||N|N
DE|DE|EFN|Cotton, Roll|1||Y|N||872.6050|4|||||N|N
DE|DE|EFS|Unit, Oral Irrigation|1||N|N||872.6510|4|||||N|N
DE|DE|EFT|Cleanser, Denture, Over The Counter|1||N|N||872.3520|4|||||N|N
DE|DE|EFW|Toothbrush, Manual|1||Y|N||872.6855|4|||||N|N
DE|DE|EFX|Protector, Silicate|1||Y|N||872.6670|4|||||N|N
DE|DE|EGD|Wax, Dental, Intraoral|1||Y|N||872.6890|4|||||N|N
DE|DE|EGG|Attachment, Precision, All|1||N|N||872.3165|4|||||N|N
DE|DE|EGI|Parallelometer|1||N|P||872.4565|4|||||N|N
DE|DE|EGM|Injector, Jet, Mechanical-Powered|2||N|P||872.4475|1|||||N|N
DE|DE|EGN|Scissors, Surgical Tissue, Dental|1||N|N||872.4565|4|||||N|N
DE|DE|EGQ|Injector, Jet, Gas-Powered|2||N|P||872.4465|1|||||N|N
DE|DE|EGS|Handpiece, Contra- And Right-Angle Attachment, Dental|1||N|Y|M|872.4200|1|||||N|N
DE|DE|EGZ|Holder, Film, X-Ray|1||Y|N||872.1905|4|||||N|N
DE|DE|EHA|Aligner, Beam, X-Ray|1||N|N||872.1820|4|||||N|N
DE|DE|EHE|Dispenser, Mercury And/Or Alloy|1||N|N||872.3080|4|||||N|N
DE|DE|EHJ|Disk, Abrasive|1||Y|N||872.6010|4|||||N|N
DE|DE|EHK|Cup, Prophylaxis|1||Y|N||872.6290|4|||||N|N
DE|DE|EHL|Point, Abrasive|1||Y|N||872.6010|4|||||N|N
DE|DE|EHM|Strip, Polishing Agent|1||Y|N||872.6010|4|||||N|N
DE|DE|EHO|Bar, Preformed|1||N|N||872.3165|4|||||N|N
DE|DE|EHP|Clasp, Preformed|1||N|N||872.3285|4|||||N|N
DE|DE|EHQ|Cusp, Preformed|1||N|N||872.3360|4|||||N|N
DE|DE|EHR|Pad, Denture, Over The Counter|2||N|P||872.3540|4|||||N|N
DE|DE|EHS|Cushion, Denture, Over The Counter|2||N|P||872.3540|4|||||N|N
DE|DE|EHY|Tray, Impression, Preformed|1||Y|N||872.6880|4|||||N|N
DE|DE|EHZ|Evacuator, Oral Cavity|1||N|Y|M|872.6640|4|||||N|N
DE|DE|EIA|Unit, Operative Dental|1||N|Y|M|872.6640|1|||||N|N
DE|DE|EIB|Syringe, Irrigating (Dental)|1||N|P||872.4565|4|||||N|N
DE|DE|EIC|Syringe, Periodontic, Endodontic, Irrigating|1||N|N||872.4565|4|||||N|N
DE|DE|EID|Syringe, Restorative And Impression Material|1||N|N||872.4565|4|||||N|N
DE|DE|EIE|Dam, Rubber|1||Y|N||872.6300|4|||||N|N
DE|DE|EIF|Accessories, Retractor, Dental|1||N|N||872.4565|4|||||N|N
DE|DE|EIG|Retractor, All Types|1||N|N||872.4565|4|||||N|N
DE|DE|EIH|Powder, Porcelain|2||N|P||872.6660|1|||||N|N
DE|DE|EIK|Carver, Wax, Dental|1||N|N||872.4565|4|||||N|N
DE|DE|EIL|Gauge, Depth, Instrument, Dental|1||N|N||872.4565|4|||||N|N
DE|DE|EIR|Scissors, Collar And Crown|1||N|N||872.4565|4|||||N|N
DE|DE|EIS|Remover, Crown|1||N|N||872.4565|4|||||N|N
DE|DE|EIT|Applicator, Rapid Wax, Dental|2||N|N||872.3060|4|||||N|N
DE|DE|EIX|Probe, Periodontic|1||N|N||872.4565|4|||||N|N
DE|DE|EIY|Instrument, Filling, Plastic, Dental|1||N|N||872.4565|4|||||N|N
DE|DE|EJB|Handle, Instrument, Dental|1||N|N||872.4565|4|||||N|N
DE|DE|EJE|Frame, Rubber Dam|1||Y|N||872.6300|4|||||N|N
DE|DE|EJF|Bracket, Metal, Orthodontic|1||N|N||872.5410|4|||||N|N
DE|DE|EJG|Forceps, Rubber Dam Clamp|1||Y|N||872.6300|4|||||N|N
DE|DE|EJH|Alloy, Metal, Base|2||N|Y|M|872.3710|4|||||N|N
DE|DE|EJI|Syringe, Cartridge|2||N|P||872.6770|1|||||N|N
DE|DE|EJJ|Alloy, Amalgam|2||N|P||872.3070|1|||||N|N
DE|DE|EJK|Liner, Cavity, Calcium Hydroxide|2||N|P||872.3250|1|||||N|N
DE|DE|EJL|Bur, Dental|1||N|N||872.3240|4|||||N|N
DE|DE|EJP|Articulators|1||Y|N||872.3150|4|||||N|N
DE|DE|EJQ|Wheel, Polishing Agent|1||Y|N||872.6010|4|||||N|N
DE|DE|EJR|Agent, Polishing, Abrasive, Oral Cavity|1||N|N||872.6030|4|||||N|N
DE|DE|EJS|Alloy, Other Noble Metal|2||N|Y|M|872.3060|4|||||N|N
DE|DE|EJT|Alloy, Gold-Based Noble Metal|2||N|Y|M|872.3060|4|||||N|N
DE|DE|EJW|Clasp, Wire|1||N|N||872.3285|4|||||N|N
DE|DE|EJX|Anchor, Preformed|1||N|N||872.3130|4|||||N|N
DE|DE|EJY|Pliers, Operative|1||N|N||872.4565|4|||||N|N
DE|DE|EJZ|Knife, Margin Finishing, Operative|1||N|N||872.4565|4|||||N|N
DE|DE|EKA|File, Margin Finishing, Operative|1||N|N||872.4565|4|||||N|N
DE|DE|EKB|Explorer, Operative|1||N|N||872.4565|4|||||N|N
DE|DE|EKC|Excavator, Dental, Operative|1||N|N||872.4565|4|||||N|N
DE|DE|EKD|Instrument, Cutting, Operative|1||N|N||872.4565|4|||||N|N
DE|DE|EKE|Curette, Operative|1||N|N||872.4565|4|||||N|N
DE|DE|EKF|Instrument, Contouring, Matrix, Operative|1||N|N||872.4565|4|||||N|N
DE|DE|EKG|Condenser, Amalgam And Foil, Operative|1||N|N||872.4565|4|||||N|N
DE|DE|EKH|Carver, Dental Amalgam, Operative|1||N|N||872.4565|4|||||N|N
DE|DE|EKI|Carrier, Amalgam, Operative|1||N|N||872.4565|4|||||N|N
DE|DE|EKJ|Burnisher, Operative|1||N|N||872.4565|4|||||N|N
DE|DE|EKK|Spreader, Pulp Canal Filling Material, Endodontic|1||N|N||872.4565|4|||||N|N
DE|DE|EKL|Point, Silver, Endodontic|1||N|N||872.3840|4|||||N|N
DE|DE|EKM|Gutta-Percha|1||N|N||872.3850|4|||||N|N
DE|DE|EKN|Point, Paper, Endodontic|1||N|N||872.3830|4|||||N|N
DE|DE|EKO|Denture Preformed (Partially Prefabricated Denture)|2||N|P||872.3600|4|||||N|N
DE|DE|EKP|Reamer, Pulp Canal, Endodontic|1||N|N||872.4565|4|||||N|N
DE|DE|EKQ|Preparer, Root Canal Endodontic|1||N|N||872.4565|4|||||N|N
DE|DE|EKR|Plugger, Root Canal, Endodontic|1||N|N||872.4565|4|||||N|N
DE|DE|EKS|File, Pulp Canal, Endodontic|1||N|N||872.4565|4|||||N|N
DE|DE|EKT|Curette, Endodontic|1||N|N||872.4565|4|||||N|N
DE|DE|EKW|Broach, Endodontic|1||N|N||872.4565|4|||||N|N
DE|DE|EKX|Handpiece, Direct Drive, Ac-Powered|1||N|Y|M|872.4200|1|||||N|N
DE|DE|EKY|Handpiece, Water-Powered|1||N|Y|M|872.4200|1|||||N|N
DE|DE|EKZ|Unit, Electrosurgical, And Accessories, Dental|2||N|P||872.4920|1|||||N|N
DE|DE|ELA|Instrument, Hand, Calculus Removal|1||N|N||872.4565|4|||||N|N
DE|DE|ELB|Scaler, Rotary|2||N|P||872.4840|1|||||N|N
DE|DE|ELC|Scaler, Ultrasonic|2||N|P||872.4850|1|||||N|N
DE|DE|ELE|Implant, Subperiosteal|2||N|N||872.3645|1|||||Y|N
DE|DE|ELJ|Teeth, Artificial, Posterior With Metal Insert|1||N|N||872.3900|4|||||N|N
DE|DE|ELK|Teeth, Artificial, Backing And Facing|1||N|N||872.3910|4|||||N|N
DE|DE|ELL|Teeth, Porcelain|2||N|P||872.3920|1|||||N|N
DE|DE|ELM|Denture, Plastic, Teeth|2||N|P||872.3590|4|||||N|N
DE|DE|ELN|Teeth, Preformed Gold Denture|1||N|N||872.3580|4|||||N|N
DE|DE|ELO|Cusp, Gold And Stainless Steel|1||N|N||872.3350|4|||||N|N
DE|DE|ELR|Post, Root Canal|1||N|N||872.3810|4|||||N|N
DE|DE|ELS|Splint, Endodontic Stabilizing|2||N|P||872.3890|4|||||N|N
DE|DE|ELW|Material, Impression|2||N|Y|M|872.3660|1|||||N|N
DE|DE|ELY|Mercury|2||N|Y||872.3070|1|||||N|N
DE|DE|ELZ|Crown, Preformed|1||N|N||872.3330|4|||||N|N
DE|DE|EMA|Cement, Dental|2||N|Y|M|872.3275|1|||||N|N
DE|DE|EMB|Zinc Oxide Eugenol|1||N|N||872.3275|4|||||N|N
DE|DE|EMD|Hemostat, Surgical|1||N|N||872.4565|4|||||N|N
DE|DE|EME|Punch, Biopsy, Surgical|1||N|N||872.4565|4|||||N|N
DE|DE|EMG|Forceps, Tooth Extractor, Surgical|1||N|N||872.4565|4|||||N|N
DE|DE|EMH|Forceps, Rongeur, Surgical|1||N|N||872.4565|4|||||N|N
DE|DE|EMI|File, Bone, Surgical|1||N|N||872.4565|4|||||N|N
DE|DE|EMJ|Elevator, Surgical, Dental|1||N|N||872.4565|4|||||N|N
DE|DE|EMK|Curette, Surgical, Dental|1||N|N||872.4565|4|||||N|N
DE|DE|EML|Chisel, Bone, Surgical|1||N|N||872.4565|4|||||N|N
DE|DE|EMM|Chisel, Osteotome, Surgical|1||N|N||872.4565|4|||||N|N
DE|DE|EMN|Scaler, Periodontic|1||N|N||872.4565|4|||||N|N
DE|DE|EMO|Knife, Periodontic|1||N|N||872.4565|4|||||N|N
DE|DE|EMP|Marker, Periodontic|1||N|N||872.4565|4|||||N|N
DE|DE|EMQ|Hoe, Periodontic|1||N|N||872.4565|4|||||N|N
DE|DE|EMR|File, Periodontic|1||N|N||872.4565|4|||||N|N
DE|DE|EMS|Curette, Periodontic|1||N|N||872.4565|4|||||N|N
DE|DE|JEO|Measurer, Gingival Fluid|1||N|N||872.1500|4|||||N|N
DE|DE|JEP|Retainer, Matrix|1||N|N||872.4565|4|||||N|N
DE|DE|JEQ|Toothbrush, Powered|1||N|N||872.6865|4|||||N|N
DE|DE|JER|Cleaner, Denture, Mechanical|1||N|N||872.3530|4|||||N|N
DE|DE|JES|Floss, Dental|1||N|N||872.6390|4|||||N|N
DE|DE|JET|Pick, Massaging|1||Y|N||872.6650|4|||||N|N
DE|DE|JEW|Tip, Rubber, Oral Hygiene|1||Y|N||872.6650|4|||||N|N
DE|DE|JEX|Plier, Orthodontic|1||N|N||872.4565|4|||||N|N
DE|DE|JEY|Plate, Bone|2||N|N||872.4760|1|||||Y|N
DE|DE|KCQ|Tube Impression And Matrix|1||Y|N||872.6570|4|||||N|N
DE|DE|KCR|Facebow|1||Y|N||872.3220|4|||||N|N
DE|DE|KCS|Pantograph|1||Y|N||872.3730|4|||||N|N
DE|DE|KHR|Absorber, Saliva, Paper|1||Y|N||872.6050|4|||||N|N
DE|DE|KIF|Resin, Root Canal Filling|2||N|P||872.3820|1|||||N|N
DE|DE|KKO|Ring, Teething, Fluid-Filled|2||N|P||872.5550|4|||||N|N
DE|DE|KLC|Chair, Dental, With Operative Unit|1||N|Y|M|872.6250|1|||||N|N
DE|DE|KLE|Agent, Tooth Bonding, Resin|2||N|Y|M|872.3200|1|||||N|N
DE|DE|KMT|Tray, Fluoride, Disposable|1||Y|N||872.6870|4|||||N|N
DE|DE|KMW|Handpiece, Rotary Bone Cutting|2||N|P||872.4120|1|||||N|N
DE|DE|KMY|Positioner, Tooth, Preformed|1||N|N||872.5525|4|||||N|N
DE|DE|KOJ|Airbrush|2||N|P||872.6080|1|||||N|N
DE|DE|KOK|Sterilizer, Endodontic Dry Heat|3||N|N||872.6730|2|Call for PMAs on 4/21/97 per 62 FR 2902 on 1/21/97||||N|N
DE|DE|KOL|Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer|1||N|N||872.3410|4|||||N|N
DE|DE|KOM|Adhesive, Denture, Acacia And Karaya With Sodium Borate|1||N|N||872.3400|4|||||N|N
DE|DE|KON|Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic)|3||N|N||872.3480|2|Call for PMAs 12/26/96 per 61 FR 50707 on 9/26/96||||N|N
DE|DE|KOO|Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt|1||N|N||872.3490|4|||||N|N
DE|DE|KOP|Adhesive, Denture, Karaya|1||N|N||872.3450|4|||||N|N
DE|DE|KOQ|Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)|1||N|N||872.3410|4|||||N|N
DE|DE|KOR|Adhesive, Denture, Karaya With Sodium Borate|3||N|N||872.3400|2|||||N|N
DE|DE|KOS|Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer|3||N|N||872.3420|2|||||N|N
DE|DE|KOT|Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium|1||N|N||872.3490|4|||||N|N
DE|DE|KXR|Applicator, Resin|1||Y|N||872.3140|4|||||N|N
DE|DE|KXW|Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer|1||N|N||872.3410|4|||||N|N
DE|DE|KXX|Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer|1||N|N||872.3450|4|||||N|N
DE|DE|KXY|Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce|3||N|N||872.3500|2|Call for PMAs 12/26/96 per 61 FR 50707 on 9/27/96||||N|N
DE|DE|KZN|Scanner, Color|2||N|N||872.3661|4|||||N|N
DE|DE|KZO|Ink, Arch Tracing|1||Y|N||872.3150|4|||||N|N
DE|DE|KZP|Solution, Cement Disolving|2||N|P||872.3750|1|||||N|N
DE|DE|LBH|Varnish, Cavity|2||N|P||872.3260|1|||||N|N
DE|DE|LCN|Scraper, Tongue|1||Y|N||872.6855|4|||||N|N
DE|DE|LFC|Device, Caries Detection|2||N|P||872.1740|1|||||N|N
DE|DE|LPK|Bone Grafting Material, For Dental Bone Repair|2||N|N||872.3930|1|Tricalcium phosphate bone grafting material||||Y|N
DE|DE|LQZ|Device, Jaw Repositioning|2||N|P||872.5570|1|||||N|N
DE|DE|LRK|Device, Anti-Snoring|2||N|Y||872.5570|1|||||N|N
DE|DE|LYC|Bone Grafting Material, Synthetic|2||N|N||872.3930|1|A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.||||Y|N
DE|DE|LZD|Joint, Temporomandibular, Implant|3||N|N||872.3940|2|Call for PMAs to be filed by 3/30/99 per 63 FR 71746 on 12/30/98 - Indicated for reconstruction of the temporomandibular joint.|The device is a ball and socket joint with one side mounted to the jaw and the other side mounted to the head right in front of the ear.|||Y|N
DE|DE|MAU|Eraser, Dental Stain|1||Y|N||872.6855|4|||||N|N
DE|DE|MCF|Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile|1||N|N||872.6855|4|||||N|N
DE|DE|MDL|Implant, Transmandibular|2||N|N||872.4760|1|||||Y|N
DE|DE|MEF|Ring, Teething, Non-Fluid Filled|1||N|N||872.5550|4|||||N|N
DE|DE|MMD|Toothbrush, Ionic, Battery-Powered|1||N|N||872.6865|4|||||N|N
DE|DE|MMT|Resin, Root Canal Filling Containing Chloroform|3||N|N||872.3820|2|||||N|N
DE|DE|MMU|Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight|3||N|N||872.3400|2|||||N|N
DE|DE|MPI|Glenoid Fossa Prosthesis|3||N|N||872.3950|2|||||N|N
DE|DE|MPJ|Interarticular Disc Prosthesis (Interpositional Implant)|3||N|N||872.3970|2|||||Y|N
DE|DE|MPL|Mandibular Condyle Prosthesis|3||N|N||872.3960|2|PMA to be filed by 3/30/99 (63 FR 71746 (12/30/98))||||N|N
DE|DE|MQN|External Mandibular Fixator And/Or Distractor|2||N|N||872.4760|1|||||Y|N
DE|DE|MVH|Device, Detection, Sulfide|2||N|Y||872.1870|1|||||N|N
DE|DE|MXF|System,Dental,Hydrokinetic,Carries Removal & Cavity Preparation|2||N|P||872.4120|1|||||N|N
DE|DE|MZW|Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief|2||N|Y||872.3275|1|||||N|N
DE|DE|NBL|Laser,Fluorescence Caries Detection|2||N|N||872.1745|1|||||N|N
DE|DE|NDP|Accessories, Implant, Dental, Endosseous|1||N|N||872.3980|4|||||N|N
DE|DE|NEI|Prosthesis, Condyle, Mandibular, Temporary|2||N|N||872.4770|1|||||Y|N
DE|DE|NFE|Materials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation|2||N|N||872.3680|1|||||N|N
DE|DE|NFP|Device, Dental Sonography, For Diagnosis Of Tmj/Mpd Disorders|2||N|N||872.2050|1|||||N|N
DE|DE|NFQ|Device, Dental Sonography, For Monitoring Jaw Sounds|1||N|N||872.2050|4|||||N|N
DE|DE|NFR|Device, Jaw Tracking, For Diagnosis Of Tmj/Mpd Disorders|2||N|N||872.2060|1|||||N|N
DE|DE|NFS|Device, Jaw Tracking, For Monitoring Jaw Positions|1||N|N||872.2060|4|||||N|N
DE|DE|NHA|Abutment, Implant, Dental, Endosseous|2||N|N||872.3630|1|To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.||||Y|N
DE|DE|NJM|Bracket, Ceramic, Orthodontic|2||N|P||872.5470|1|An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new postion.  (the current classification only specifies plastic brackets.  Confusion exists as to whether ceramic brackets are regulated.)||||N|N
DE|DE|NKJ|Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter|1||N|N||872.3540|4|OTC denture cushion or pad made of wax impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into the mouth. The Device is intended to be discarded following 1 day's use.||||N|N
DE|DE|NLC|Bracket, Plastic, Orthodontic, Reprocessed|2||N|N||872.5470|1|same as DYW except it is being reprocessed||||N|N
DE|DE|NLD|Instrument, Diamond, Dental, Reprocessed|1||N|N||872.4535|1|same as DZP except reprocessed||||N|N
DE|DE|NME|Bur, Diamond Coated, Reprocessed|1||N|N||872.3240|1|||||N|N
DE|DE|NMW|Needle, Dental, Reprocessed|1||N|N||872.4730|1|||||N|N
DE|DE|NOB|Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile|1||Y|N||872.6855|4|manual toothbrush; see product code MCF||||N|N
DE|DE|NOF|System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations|2||N|N||872.3661|4|An optical impression system for cad/cam of dental restorations is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer aided design and manufacturing of dental restorative prosthetic devices.  Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with software.||||N|N
DE|DE|NPK|Barrier, Synthetic, Intraoral|2||N|N||872.3930|1|A synthetic dental barrier is a synthetic material device, such as ptfe, intended to aid in guided tissue and/or bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials.||||Y|N
DE|DE|NPL|Barrier, Animal Source, Intraoral|2||N|N||872.3930|1|An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.||||Y|N
DE|DE|NPM|Bone Grafting Material, Animal Source|2||N|N||872.3930|1|A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.||||Y|N
DE|DE|NPZ|Bone Grafting Material, Dental, With Biologic Component|3||N|N||872.3930|2|Dental bone grafting material with growth factors is a combination product which consists of a bone grafting material which contains biologic or drug components, such as proteins, that are intended to stimulate and/or inhibit the growth of certain tissues of the oral and maxillofacial region.||||Y|N
DE|DE|NQA|Biologic Material, Dental|3||N|N||872.3930|2|Other dental material with growth factors is a material, used with or without other devices, which contains biologic or drug components, such as proteins, that are intended to stimulate and/or inhibit the growth of certain tissues of the oral and maxillofacial region.||||Y|N
DE|DE|NQS|Bracket, Metal, Orthodontic, Reprocessed|1||N|N||872.5410|1|Intended for use in orthodontic treatment.  The device is affixed to a tooth so that pressure can be exerted on the teeth.||||N|N
DE|DE|NRD|Unit, Operative Dental, Accessories|1||N|N||872.6640|4|Air compressor and vacuum unit that are connected to dental operative unit to provide compressed air and vacuum capability to power and drive other dental devices, which are attached to the dental operative unit.||||N|N
DE|DE|NRQ|Blade-Form Endosseous Dental Implant|2||N|N||872.3640|1|Device made of a material such as titanium or titanium alloy, that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.||||Y|N
DE|DE|NRU|Chair, Dental, Without Operative Unit|1||N|N||872.6250|4|A dental chair is a device, usually powered, that is intended to seat a patient in the proper position to perform a dental procedure.||||N|N
DE|DE|NTK|Caries Detector, Laser Light, Transmission|2||N|N||872.1745|1|||||N|N
DE|DE|NTO|Rinse, Oral, Antibacterial (By Physical Means)|2||N|N||872.5580|1|Antibacterial oral rinse that is used as an aid in the treatment of gingivitis, acting by physical rather than chemical means. The rinse works by coating tooth and tissue surfaces, providing a positive charge that reduces bacterial adhesion.||||N|N
DE|DE|NUN|Bone Grafting Material, Human Source|2||N|N||872.3930|1|INTENDED TO BE PACKED INTO BONY VOIDS OR GAPS TO FILL AND/OR AUGMENT DENTAL INTRAOSSEOUS, ORAL AND CRANIO-/MAXILLOFACIAL DEFECTS.  THESE DEFECTS MAY BE SURGICALLY CREATD OSSEOUS DEFECTS OR OSSEOUS DEFECTS CREATED FROM TRAUMATIC INJRY TO THE BONE, INLCUDING PERIODENTA/INFRABONY DEFECTS; ALVEOLAR RIDGE AUGMENTATION (SINUSOTOMY, OSTEOTOMY, CYSTECTOMY); DENTAL EXTRACTION SITES (RIDGE MAINTENANCE, IMPLANT PREPARATION/PLACEMENT); SINUS LIFTS; CYSTIC DEFECTS; CRANIOFACIAL AUGMENTATION.||||Y|N
DE|DE|NUX|Cleanser, Denture, Prescription|1||N|P||872.3520|4|Effervescent tablet for the removal of micro-organisms from removable dentures and retainers.||||N|N
DE|DE|NXC|Aligner, Sequential|2||N|P||872.5470|1|The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.|Device is composed of a thermoplastic resin.  It may also be accompanied by software and/or hardware for patient scanning.|Digital scans of patient's dentition are used to create a series of plastic appliances which are intented to progressively move teeth.|The teeth|N|N
DE|DE|NXV|Diagnostic Light, Soft Tissue Detector|2||N|N||872.6350|1|To be used as an aid in the detection or visualization of abnormalities of intraoral soft tissue.  An adjunct to traditional intraoral examination by incandescent light to enhance the visualization of oral mucosal abnormalities|The device consists of a light source with light guide cable or a handpiece based light emitting apparatus.  Added components may or may not block or filter out light inundesired frequencies.  The reflected light reveals tissue characteristics that are abnormal, or are suspected to be abnormal.|The device emits a light in a specific wavelength range causing intraoral tissues to fluoresce or return or reflect light in another wavelength range in a detectable manner.|Intraoral soft tissues.|N|N
DE|DE|NXZ|Dental Hygiene Kit|1||Y|N||872.6855|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
DE|DE|NYC|Dental Prophylaxis Kit |2||N|N||872.4850|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
DE|DE|NYD|Endodontic Kit|2||N|N||872.3820|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
DE|DE|NYE|Dental Fixture Mount Kit|1||N|N||872.3980|7|Fixture dental mount kit may contain hand instruments, drill bits, and screw drivers. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
DE|DE|NYG|Dental Lapping Tool Kit|1||N|N||872.4565|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
DE|DE|NYH|Plaque Disclosing Kit|2||N|N||872.1740|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
DE|DE|NYL|Handpiece, Air-Powered, Root Canal Irrigation|1||N|N||872.4200|1|To clean the root canal prior to filling and used for root canal irrigation.|It is composed or aluminum, stainless steel and plastic|It is attached to the coupling for the dental handpiece and is used to provide irrigation solution into the root canal|It is used to treat a tooth during a root canal procedure|N|N
DE|DE|OAT|Implant, Endosseous, Orthodontic|2||N|N||872.3640|1|It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.  It is used temporarily and is removed after orthodontic treatment has been completed.|Generally fabricated from titanium or titanium alloy in a screw form or screw and plate combination.|It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices.|Maxilla and mandibular jaw bone.|Y|N
DE|DE|OFW|Restorative Instrument And Component Tray (Kit)|2||N|N||872.3690|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
DE|DE|OFX|General Purpose Dental Tray (Kit)|1||N|N||872.6640|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
DE|DE|OFY|Dental Implant Surgical Tray (Kit)|1||N|N||872.3980|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
DE|DE|OHP|Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea|2||N|N||872.5570|1|Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea.|plastic with adhesive; valve that changes position with inspiration/expiration to provide decreased/increased resistance|intranasal device that creates expiratory resistance|inserted into nares of nose to maintain upper airway pressure.|N|N
DE|DE|OIV|Dental Amalgam|2||N|N||872.3070|1|Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth|Powder and liquid metals encapsulated and separated by a septum.  Forms a solid upon mixing.|Heterogeneous mixture of alloy and elemental mercury hardens to form a solid that is used as a direct filling material|Direct filling of teeth.|N|N
DE|DE|ORY|Prelude Tongue Suspension System|2||N|N||872.5570|1|Intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with a suture.  It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.|Bone screw and suture material|Physical advancement of the tongue.|Oral cavity|Y|N
DE|DE|OYH|Orthodontic Vibratory Accessory|2||N|N||872.5470|1|An orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.|The system consists of four components: The Activator, Mouthpiece, Charging Port, and Travel Shell.|The device functions by providing vibration to the teeth.  This is done for 20 minutes a day per the length of the entire treatment.|Patients with "separate canine retraction" and "en masse" retraction.|N|N
DE|DE|PFL|Intraoral, Dental Foam Protector|1||N|N||872.6890|4|Intended to provide a soft barrier between wired mouth hardware and oral mucosa.|Strip of polyethelene foam|Uses non-latex foam to cover wired mouth hardware. Foam is frictionally retained by a slit in its center.|intraoral between metal appliance on teeth and lip or cheek.|N|N
DE|DE|PHR|Diammine Silver Fluoride Dental Hypersensitivity Varnish|2||N|N||872.3260|1|Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity.|liquid, gel|precipitates upon application resulting in a physical blockage of dentinal tubules|tooth enamel|N|N
DE|DE|PIP|Prophy Powder, Airbrush Accessory|2||N|N||872.6080|1|An air polishing powder to be used with an airbrush for prophylaxis in the oral cavity.|Powder|The powder is dispensed via an electric airbrush and removes plaque via abrasion of the tooth surface by the powder granules.|Oral cavity|N|N
DE|DE|PLC|Sleep Appliances With Patient Monitoring|2||N|N||872.5570|1|For the treatment of night time snoring and mild to moderate  obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy.|Comprised of two customized splints (upper and lower) held together by a locking mechanism|advances the patient's mandible in a forward position to increase airway space and additionally monitors the patient compliance to oral appliance therapy|Patient's oral cavity|N|N
DE|DE|PLH|Orthodontic Led Accessory|2||N|N||872.5470|1|Intended for use during orthodontic treatment.  It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.|The system consists of a mouthpiece containing LEDs, software, and battery, and a separate storage/charging station.|The device functions by applying light energy to the tissue surrouding tooth roots for a photobiomodulation effect.|Alverolar ridge of maxillary and mandibular arches of patients currently being treated with orthodontic brackets/wires or aligners.|N|N
DE|DE|PLV|Dental Stereotaxic Instrument|2||N|N||872.4120|1|To facilitate dental implant placement in patients that are partially endentulous or edentulous.|A cart mounted system that physically attaches to the patient as well as the surgical instrument in order to detect the location of the device in physical space.|The device uses stereo cameras to detect tracking devices placed on both the surgical instrument as well as on the patient.  The tracked image is then placed on a screen with predetermined anatomical landmarks to assist the clinician with the surgical placement.|Intraoral surgical procedures in the mouth.|N|N
DE|HO|LFE|Solution, Cold Sterilizing|2||N|P||880.6885|1|||||N|N
DE|HO|ONK|Oral Lubricant|1||N|N||880.6375|1|An oral lubricant  to be used adjacent to hard and soft tissue and the lips to prevent adherence of dental cement; Placement of a rubber dam; And to prevent the lips from drying and cracking during dental procedures.|viscous liquid or gel|direct application|oral hard and soft tissue|N|N
DE|PM|KZM|Device, Muscle Monitoring|2||N|P||890.1375|1|||||N|N
DE|PM|LQX|Device, Finger-Sucking|1||N|N||890.3475|4|||||N|N
DE|PM|NUW|Stimulator, Muscle, Powered, Dental|2||N|P||890.5850|1|Relief of muscle spasms associated with tmj.  Muscle reeducation, increasing blood flow.||||N|N
DE|SU|NVK|Laser, Dental, Soft Tissue|2||N|N||878.4810|1|Intended for the incision,  excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and  dentistry.|Laser Unit & Delivery  System|Laser System|Teeth|N|N
DE|SU|OAJ|Catheter, Drainage, Intraoral/Extraoral|1||N|Y||878.4200|4|To allow continuous drainage of saliva and/or fluid irrigation of the salivary duct as well as assisting in maintaining duct patency during the healing process following removal of salivary gland stones for temporary insertion into the salivary gland, whether orally or through the cheek following endoscopic or surgical removal of salivary gland stones|It is a flexible, single lumen, disposable drainage cannula made of radio-opaque polyurethane material|The drainage cannula is inserted which allows the fluid to drain following endoscopic removal of salivary gland stones|Salivary gland|N|N
DE|SU|PEM|Dental Barriers And Sleeves|2||N|N||878.4370|1|Intended to serve as a disposable  barrier for dental instruments to reduce  the risk of cross contamination between dental patients.|Clear polymer film|Adhesively applied to patient contacting surfaces of reusable dental instruments/devices.|For devices to be used in dental surgery.|N|N
DE||KJJ|Cleanser, Root Canal|U|1|N|N|||1|||||N|N
DE||LFD|Saliva, Artificial|U|1|N|N|||1|||||N|N
DE||LMW|Solution, Removal, Carries|3||N|N|||2|||||N|N
DE||LPG|Material, Dressing, Surgical, Polylactic Acid|3||N|N|||2|||||N|N
DE||LQY|Locator, Root Apex|U|1|N|N|||1|||||N|N
DE||LTF|Stimulator, Salivary System|3||N|N|||2|||||N|N
DE||LTG|Paste, Injectable For Vocal Cord Augmentation|3||N|N|||2|||||N|N
DE||LWM|Device, Electrical Dental Anesthesia|U|1|N|N|||1|||||N|N
DE||LYB|Laser, Dental|U|1|N|N|||1|||||N|N
DE||MCL|Kit, Test, In Vitro Periodontal|3||N|N|||2|||||N|N
DE||MQC|Mouthguard, Prescription|U|1|N|N|||1|||||N|N
DE||MVL|Cord, Retraction|U|1|N|N|||1|||||N|N
DE||NSJ|Restoration, Noble Metal|N|6|N|N|||7|Foreign dental lab manufactured noble metal restorations are crowns, bridges, inlays, and onlays that are manufactured as finished products from noble metals.||||N|N
DE||NSK|Dentures, Partial|N|6|N|N|||7|Foreign dental lab manufactured partial dentures are manufactured as finished products from denture resins and other supporting materials.||||N|N
DE||NSL|Dentures, Full|N|6|N|N|||7|Foreign dental lab manufactured full dentures are manufactured as finished products from denture resins.||||N|N
DE||NSM|Restoration, Resin|N|6|N|N|||7|Foreign dental lab manufactured resin restorations are permanent restorations that are manufactured as finished products from resins.||||N|N
DE||NSN|Restoration, Resin, Crown And Bridge|N|6|N|N|||7|Foreign dental lab manufactured resin crown and bridge restorations are crown and bridge restorations that are manufactured as finished products from resins.||||N|N
DE||NSO|Restoration, Porcelain-Fused-To-Metal|N|6|N|N|||7|Foreign dental lab manufactured porecelain-fused-to-metal restorations are porcelain-fused-to-metal crown and bridge restorations that are manufactured as finished products from porcelain and noble or base metal alloys.||||N|N
DE||NSP|Restoration, Porcelain|N|6|N|N|||7|Foreign dental lab manufactured porcelain restorations are full porcelain crown and bridge restorations that are manufactured as finished products from porcelains.||||N|N
DE||NSQ|Restoration, Base Metal|N|6|N|N|||7|Foreign dental lab manufactured base metal restorations are crowns, bridges, inlays, and onlays that are manufactured as finished products from base metals.||||N|N
DE||NSR|Prosthesis, Orthodontic|N|6|N|N|||7|Foreign dental lab manufactured orthodontic prosthesis are finished custom-fit orthodontic prosthesis.||||N|N
DE||NXJ|Denture, Cosmetic Only|N|6|N|N|||7|Intended to improve an individual's appearance only.  Not intended to assist in chewing food.|denture rebasing resin, methylmethacrylate|Functions independently|oral cavity|N|N
DE||NYF|Gingival Retraction Kit|N|6|N|N|||7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
DE||OBR|Mouthguard, Over-The-Counter|U|1|N|N|||1|To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.|It is a material similar to a hard methylmethacrylate or a softer thermoplastic resin.|The dental mouthguard is a removable appliance that is fitted to the teeth by taking an immpression of the teeth or using a thermoplastic resin|Oral Cavity|N|N
DE||OCO|Mouthguard, Migraine/Tension Headache|U|1|N|N|||1|A device to be used in the prophylactic treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches, by reducing their signs and symptoms through reduction of trigeminally innervated muscular activity, and; For the prevention of bruxism and tmj syndrome through reduction of trigeminally innervated muscular activity.|Plastic mouthguard fitted to the teeth|Mouthguard repositions the jaw to reduce muscle tension|Oral cavity|N|N
DE||OLR|Oral Wound Dressing|U|1|N|N|||1|Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.  Unclassified status per SE to MGQ.|A viscous liquid or gel|Supplied as an oral rinse or as a gel, liquid or patch to be directly applied to an oral wound|Oral mucosal tissue|N|N
DE||OLS|Oral Wound Dressing W/Drug And/Or Biologic|U|1|N|N|||1|Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.  Unclassified status per se to mgq.|A viscous liquid or gel|Supplied as an oral rinse or as a gel, liquid or patch to be directly applied to an oral wound.|Oral mucosal tissue|N|N
DE||PKJ|Crown & Bridge Material, Resin Based|N|3|N|N|||7|Used for dental crown restorations by single crown, bridge, etc, or for indirect repair of dental crown fabrications.|Used for dental crown restorations by single crown, bridge, etc, or for indirect repair of dental crown fabrications|Used for dental crown restorations by single crown, bridge, etc, or for indirect repair of dental crown fabrications|tooth|N|N
EN|AN|OGP|Cricothyrotomy Kit|2||N|N||868.5800|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
EN|AN|OGV|Tracheostomy Cleaning Tray|2||N|N||868.5800|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
EN|AN|OGW|Tracheostomy Kit|2||N|N||868.5800|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
EN|DE|MYB|Pillow,Cervical(For Mild Sleep Apnea)|2||N|N||872.5570|1|||||N|N
EN|DE|NEA|Cement, Ear, Nose And Throat|2||N|N||872.3275|1|||||Y|N
EN|DE|OGT|Oral Irrigation Kit|1||N|N||872.6510|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
EN|EN|BST|Currette, Biopsy, Bronchoscope (Non-Rigid)|2||N|P||874.4680|1|||||N|N
EN|EN|BTG|Brush, Biopsy, Bronchoscope (Non-Rigid)|2||N|P||874.4680|1|||||N|N
EN|EN|BWH|Forceps, Biopsy, Bronchoscope (Non-Rigid)|2||N|P||874.4680|1|||||N|N
EN|EN|EMX|Balloon, Epistaxis|1||N|N||874.4100|4|||||N|N
EN|EN|ENW|Catheter, Nasopharyngeal|1||N|N||874.4175|4|||||N|N
EN|EN|ENZ|Telescope, Laryngeal-Bronchial|2||N|P||874.4680|1|||||N|N
EN|EN|EOB|Nasopharyngoscope (Flexible Or Rigid)|2||N|P||874.4760|1|||||N|N
EN|EN|EOQ|Bronchoscope (Flexible Or Rigid)|2||N|P||874.4680|1|||||N|N
EN|EN|EOX|Esophagoscope (Flexible Or Rigid)|2||N|P||874.4710|1|||||N|N
EN|EN|EPF|Hearing Aid, Group And Auditory Trainer|2||N|P||874.3320|4|||||N|N
EN|EN|EPN|Pump, Nebulizer, Manual|1||Y|N||874.5220|4|||||N|N
EN|EN|EPP|Splint, Nasal|1||N|N||874.5800|4|||||N|N
EN|EN|EQH|Source, Carrier, Fiberoptic Light|1||N|N||874.4350|4|||||N|N
EN|EN|EQJ|Bur, Ear, Nose And Throat|1||N|N||874.4140|4|||||N|N
EN|EN|EQL|Laryngostroboscope|1||N|N||874.4750|4|||||N|N
EN|EN|EQN|Laryngoscope, Nasopharyngoscope|2||N|P||874.4760|1|||||N|N
EN|EN|ERA|Otoscope|1||N|N||874.4770|4|||||N|N
EN|EN|ERL|Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece|2||N|P||874.4250|1|||||N|N
EN|EN|ESD|Hearing Aid, Air Conduction|1||N|N||874.3300|4|||||N|N
EN|EN|ESE|Larynx, Artificial (Battery-Powered)|1||N|N||874.3375|4|||||N|N
EN|EN|ESH|Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane|2||N|N||874.3620|1|||||Y|N
EN|EN|ESX|Tack, Sacculotomy (Cody Tack)|2||N|N||874.3760|1|||||Y|N
EN|EN|ESZ|Tube, Shunt, Endolymphatic|2||N|N||874.3820|1|||||Y|N
EN|EN|ETA|Replacement, Ossicular Prosthesis, Total|2||N|N||874.3495|1|||||Y|N
EN|EN|ETB|Prosthesis, Partial Ossicular Replacement|2||N|N||874.3450|1|||||Y|N
EN|EN|ETC|Mold, Middle-Ear|2||N|N||874.3430|4|||||Y|N
EN|EN|ETD|Tube, Tympanostomy|2||N|N||874.3880|1|||||Y|N
EN|EN|ETF|Unit, Examining/Treatment, Ent|1||N|N||874.5300|4|||||N|N
EN|EN|ETK|Tube, Toynbee Diagnostic|1||N|N||874.1925|4|||||N|N
EN|EN|ETM|Gustometer, Sterile|1||N|N||874.1500|4|||||N|N
EN|EN|ETN|Stimulator, Nerve|2||N|P||874.1820|1|||||N|N
EN|EN|ETP|Stimulator, Caloric-Water|1||N|N||874.1800|4|||||N|N
EN|EN|ETR|Adaptor, Short Increment Sensitivity Index (Sisi)|1||N|N||874.1070|4|||||N|N
EN|EN|ETS|Generator, Electronic Noise (For Audiometric Testing)|2||N|P||874.1120|1|||||N|N
EN|EN|ETT|Cushion, Earphone (For Audiometric Testing)|1||N|N||874.1100|4|||||N|N
EN|EN|ETW|Calibrator, Hearing Aid / Earphone And Analysis Systems|2||N|P||874.3310|4|||||N|N
EN|EN|ETY|Tester, Auditory Impedance|2||N|P||874.1090|1|||||N|N
EN|EN|EWA|Set, Audiometer Calibration|1||N|N||874.1080|4|||||N|N
EN|EN|EWC|Chamber, Acoustic (For Audiometric Testing)|1||N|N||874.1060|4|||||N|N
EN|EN|EWG|Laser, Ent Microsurgical Carbon-Dioxide|2||N|Y||874.4500|1|||||N|N
EN|EN|EWL|Prosthesis, Laryngeal (Taub)|2||N|P||874.3730|1|||||N|N
EN|EN|EWO|Audiometer|2||N|N||874.1050|4|||||N|N
EN|EN|EWQ|Saw, Surgical, Ent (Electric Or Pneumatic)|1||N|N||874.4420|4|||||N|N
EN|EN|EWT|Device, Antichoke, Suction|3||N|N||874.5350|2|Call for PMAs on 7/13/99 per 64 FR 18329 on 4/14/99||||N|N
EN|EN|EWW|Device, Antichoke, Tongs|3||N|N||874.5370|2|||||N|N
EN|EN|EWY|Mediastinoscope, Surgical|2||N|P||874.4720|1|||||N|N
EN|EN|JAZ|Prosthesis, Facial, Mandibular Implant|2||N|N||874.3695|1|||||Y|N
EN|EN|JEI|Claw, Foreign Body, Bronchoscope (Non-Rigid)|2||N|P||874.4680|1|||||N|N
EN|EN|JEJ|Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)|2||N|P||874.4680|1|||||N|N
EN|EN|JEK|Forceps, Biopsy, Bronchoscope (Rigid)|2||N|P||874.4680|1|||||N|N
EN|EN|JEL|Curette, Biopsy, Bronchoscope (Rigid)|2||N|P||874.4680|1|||||N|N
EN|EN|JOF|Polymer, Ent Synthetic, Porous Polyethylene|2||N|N||874.3620|1|||||Y|N
EN|EN|JPW|Pump, Nebulizer, Electrically Powered|1||Y|N||874.5220|4|||||N|N
EN|EN|JXS|Block, Cutting, Ent, Sterile|1||N|N||874.3540|4|||||N|N
EN|EN|JXT|Crimper, Wire, Ent, Sterile|1||N|N||874.3540|4|||||N|N
EN|EN|JXW|Die, Wire Bending, Ent, Sterile|1||N|N||874.3540|4|||||N|N
EN|EN|JXX|Forceps, Wire Closure, Ent, Sterile|1||N|N||874.3540|4|||||N|N
EN|EN|JXY|Jig, Piston Cutting, Ent, Sterile|1||N|N||874.3540|4|||||N|N
EN|EN|JXZ|Punch, Gelfoam, Sterile|1||N|N||874.3540|4|||||N|N
EN|EN|JYA|Scissors, Wire Cutting, Ent, Sterile|1||N|N||874.3540|4|||||N|N
EN|EN|JYB|Vise, Ossicular Finger, Sterile|1||N|N||874.3540|4|||||N|N
EN|EN|JYE|Chisel, Middle-Ear|1||N|N||874.4420|4|||||N|N
EN|EN|JYF|Clamp, Ossicle Holding|1||N|N||874.4420|4|||||N|N
EN|EN|JYG|Curette, Ear|1||N|N||874.4420|4|||||N|N
EN|EN|JYH|Excavator, Ear|1||N|N||874.4420|4|||||N|N
EN|EN|JYI|Gauge, Mastoid|1||N|N||874.4420|4|||||N|N
EN|EN|JYJ|Gauge, Measuring|1||N|N||874.4420|4|||||N|N
EN|EN|JYL|Hook, Microsurgical Ear|1||N|N||874.4420|4|||||N|N
EN|EN|JYM|Inserter, Myringotomy Tube|1||N|N||874.4420|4|||||N|N
EN|EN|JYN|Inserter, Sacculotomy Tack|1||N|N||874.4420|4|||||N|N
EN|EN|JYO|Knife, Ear|1||N|N||874.4420|4|||||N|N
EN|EN|JYP|Knife, Myringotomy|1||N|N||874.4420|4|||||N|N
EN|EN|JYQ|Loop, Wire|1||N|N||874.4420|4|||||N|N
EN|EN|JYR|Nipper, Malleus|1||N|N||874.4420|4|||||N|N
EN|EN|JYS|Perforator, Ear-Lobe|1||N|N||874.4420|4|||||N|N
EN|EN|JYT|Pick, Microsurgical Ear|1||N|N||874.4420|4|||||N|N
EN|EN|JYW|Press, Vein|1||N|N||874.4420|4|||||N|N
EN|EN|JYX|Punch, Attic|1||N|N||874.4420|4|||||N|N
EN|EN|JYY|Rasp, Ear|1||N|N||874.4420|4|||||N|N
EN|EN|JYZ|Rod, Measuring Ear|1||N|N||874.4420|4|||||N|N
EN|EN|JZA|Rongeur, Mastoid|1||N|N||874.4420|4|||||N|N
EN|EN|JZB|Scissors, Ear|1||N|N||874.4420|4|||||N|N
EN|EN|JZC|Searcher, Mastoid|1||N|N||874.4420|4|||||N|N
EN|EN|JZD|Snare, Ear|1||N|N||874.4420|4|||||N|N
EN|EN|JZE|Spoon, Ear|1||N|N||874.4420|4|||||N|N
EN|EN|JZF|Tube, Ear Suction|1||N|N||874.4420|4|||||N|N
EN|EN|JZY|Knife, Laryngeal|1||N|N||874.4420|4|||||N|N
EN|EN|JZZ|Saw, Laryngeal|1||N|N||874.4420|4|||||N|N
EN|EN|KAA|Set, Laryngeal Injection|1||N|N||874.4420|4|||||N|N
EN|EN|KAB|Trocar, Laryngeal|1||N|N||874.4420|4|||||N|N
EN|EN|KAC|Tube, Laryngectomy|1||N|N||874.4420|4|||||N|N
EN|EN|KAD|Elevator, Ent|1||N|N||874.4420|4|||||N|N
EN|EN|KAE|Forceps, Ent|1||N|N||874.4420|4|||||N|N
EN|EN|KAH|Microrule, Ent|1||N|N||874.4420|4|||||N|N
EN|EN|KAI|Mirror, Ent|1||N|N||874.4420|4|||||N|N
EN|EN|KAJ|Mobilizer, Ent|1||N|N||874.4420|4|||||N|N
EN|EN|KAK|Probe, Ent|1||N|N||874.4420|4|||||N|N
EN|EN|KAL|Retractor, Ent|1||N|N||874.4420|4|||||N|N
EN|EN|KAO|Curette, Ethmoid|1||N|N||874.4420|4|||||N|N
EN|EN|KAP|Curette, Nasal|1||N|N||874.4420|4|||||N|N
EN|EN|KAQ|Gouge, Nasal, Ent|1||N|N||874.4420|4|||||N|N
EN|EN|KAR|Irrigator, Sinus|1||N|N||874.4420|4|||||N|N
EN|EN|KAS|Knife, Nasal|1||N|N||874.4420|4|||||N|N
EN|EN|KAT|Perforator, Antrum|1||N|N||874.4420|4|||||N|N
EN|EN|KAW|Punch, Antrum|1||N|N||874.4420|4|||||N|N
EN|EN|KAX|Punch, Ethmoid|1||N|N||874.4420|4|||||N|N
EN|EN|KAY|Punch, Nasal|1||N|N||874.4420|4|||||N|N
EN|EN|KAZ|Rasp, Frontal-Sinus|1||N|N||874.4420|4|||||N|N
EN|EN|KBA|Rasp, Nasal|1||N|N||874.4420|4|||||N|N
EN|EN|KBB|Rongeur, Nasal|1||N|N||874.4420|4|||||N|N
EN|EN|KBC|Saw, Nasal|1||N|N||874.4420|4|||||N|N
EN|EN|KBD|Scissors, Nasal|1||N|N||874.4420|4|||||N|N
EN|EN|KBE|Snare, Nasal|1||N|N||874.4420|4|||||N|N
EN|EN|KBF|Trephine, Sinus|1||N|N||874.4420|4|||||N|N
EN|EN|KBG|Trocar, Sinus|1||N|N||874.4420|4|||||N|N
EN|EN|KBH|Adenotome|1||N|N||874.4420|4|||||N|N
EN|EN|KBI|Bougie, Eustachian|1||N|N||874.4175|4|||||N|N
EN|EN|KBJ|Curette, Adenoid|1||N|N||874.4420|4|||||N|N
EN|EN|KBK|Curette, Salpingeal|1||N|N||874.4420|4|||||N|N
EN|EN|KBL|Depressor, Metal Tongue, Surgical|1||N|N||874.4420|4|||||N|N
EN|EN|KBM|Dissector, Tonsil|1||N|N||874.4420|4|||||N|N
EN|EN|KBN|Gag, Mouth|1||N|N||874.4420|4|||||N|N
EN|EN|KBO|Guillotine, Tonsil|1||N|N||874.4420|4|||||N|N
EN|EN|KBP|Hook, Tonsil Suturing|1||N|N||874.4420|4|||||N|N
EN|EN|KBQ|Knife, Tonsil|1||N|N||874.4420|4|||||N|N
EN|EN|KBR|Needle, Tonsil Suturing|1||N|N||874.4420|4|||||N|N
EN|EN|KBS|Punch, Adenoid|1||N|N||874.4420|4|||||N|N
EN|EN|KBT|Punch, Tonsil|1||N|N||874.4420|4|||||N|N
EN|EN|KBW|Screw, Oral|1||N|N||874.4420|4|||||N|N
EN|EN|KBX|Screw, Tonsil|1||N|N||874.4420|4|||||N|N
EN|EN|KBY|Set, Filliform, Eustachian|1||N|N||874.4175|4|||||N|N
EN|EN|KBZ|Snare, Tonsil|1||N|N||874.4420|4|||||N|N
EN|EN|KCA|Tonsillectome|1||N|N||874.4420|4|||||N|N
EN|EN|KCB|Tube, Tonsil Suction|1||N|N||874.4420|4|||||N|N
EN|EN|KCC|Bistoury, Tracheal|1||N|N||874.4420|4|||||N|N
EN|EN|KCD|Bougie, Esophageal, Ent|1||N|N||874.4420|4|||||N|N
EN|EN|KCF|Dilator, Esophageal, Ent|1||N|N||874.4420|4|||||N|N
EN|EN|KCG|Dilator, Tracheal|1||N|N||874.4420|4|||||N|N
EN|EN|KCH|Hook, Tracheal|1||N|N||874.4420|4|||||N|N
EN|EN|KCI|Trocar, Tracheal|1||N|N||874.4420|4|||||N|N
EN|EN|KCJ|Applicator, Ent|1||Y|N||874.5220|4|||||N|N
EN|EN|KCL|Blower, Powder, Ent|1||Y|N||874.5220|4|||||N|N
EN|EN|KCM|Dropper, Ent|1||Y|N||874.5220|4|||||N|N
EN|EN|KCN|Ear Wick|1||Y|N||874.5220|4|||||N|N
EN|EN|KCO|Inhaler, Nasal|1||Y|N||874.5220|4|||||N|N
EN|EN|KCP|Syringe, Ent|1||Y|N||874.5220|4|||||N|N
EN|EN|KHH|Stimulator, Caloric-Air|1||N|N||874.1800|4|||||N|N
EN|EN|KHJ|Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)|2||N|N||874.3620|1|||||Y|N
EN|EN|KHL|Hearing Aid, Master|2||N|P||874.3330|4|||||N|N
EN|EN|KLW|Masker, Tinnitus|2||N|Y||874.3400|1|||||N|N
EN|EN|KLX|Electroglottograph|2||N|P||874.1325|4|||||N|N
EN|EN|KLZ|Tube, Shunt, Endolymphatic With Valve|2||N|N||874.3850|1|||||Y|N
EN|EN|KMA|Irrigator, Powered Nasal|1||N|N||874.5550|4|||||N|N
EN|EN|KQL|Tube, Tympanostomy With Semi-Permeable Membrane|2||N|N||874.3930|1|||||Y|N
EN|EN|KTE|Trocar, Ent|1||N|N||874.4420|4|||||N|N
EN|EN|KTF|Punch, Ent|1||N|N||874.4420|4|||||N|N
EN|EN|KTG|Knife, Ent|1||N|N||874.4420|4|||||N|N
EN|EN|KTH|Device, Anti-Stammering|1||N|N||874.5840|4|||||N|N
EN|EN|KTI|Bronchoscope Accessory|2||N|Y||874.4680|1|||||N|N
EN|EN|KTR|Tube, Aspirating, Bronchoscope, Rigid|2||N|P||874.4680|1|||||N|N
EN|EN|LBL|Tube, Tympanostomy, Porous Polyethylene|2||N|N||874.3880|1|||||Y|N
EN|EN|LBM|Porous Polyethylene Ossicular Replacement|2||N|N||874.3450|1|||||Y|N
EN|EN|LBN|Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene|2||N|N||874.3495|1|||||Y|N
EN|EN|LBP|Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material|2||N|N||874.3450|1|||||Y|N
EN|EN|LDG|Kit, Earmold, Impression|1||N|N||874.3300|4|||||N|N
EN|EN|LJW|Tracheotome|1||N|N||874.4420|4|||||N|N
EN|EN|LMS|Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolarngology|2||N|Y||874.4490|1|||||N|N
EN|EN|LRB|Face Plate Hearing Aid|1||N|N||874.3300|4|||||N|N
EN|EN|LRC|Instrument, Ent Manual Surgical|1||N|N||874.4420|4|||||N|N
EN|EN|LRD|Applicator, Ent Drug|1||Y|N||874.5220|4|||||N|N
EN|EN|LRE|Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile|1||N|N||874.3540|4|||||N|N
EN|EN|LWF|Dilator, Nasal|1||N|N||874.3900|4|||||N|N
EN|EN|LXB|Hearing Aid, Bone Conduction|2||N|P||874.3300|1|||||N|N
EN|EN|LXR|Laser, Microsurgical Argon, For Use In Otology|2||N|Y||874.4490|1|||||N|N
EN|EN|LYA|Splint, Intranasal Septal|1||N|N||874.4780|4|||||N|N
EN|EN|LYN|Apparatus, Visual Reinforcement Audiometric|2||N|N||874.1050|4|||||N|N
EN|EN|LZI|Device, Assistive Listening|2||N|N||874.3320|4|||||N|N
EN|EN|MAH|Hearing Aid, Bone Conduction, Implanted|2||N|N||874.3300|1|||||Y|N
EN|EN|MCK|Device, Voice Amplification|2||N|P||874.3730|1|||||N|N
EN|EN|MIX|System, Vocal Cord Medialization|2||N|N||874.3620|1|||||Y|N
EN|EN|MMO|Tray, Surgical, Ent|1||N|N||874.4420|4|||||N|N
EN|EN|MQW|Transilluminator, Fiber Optic|1||N|N||874.4350|4|||||N|N
EN|EN|MXP|Bone Particle Collector|1||N|N||874.4800|4|||||N|N
EN|EN|NAS|Tympanometer|2||N|P||874.1090|1|||||N|N
EN|EN|NHB|Polymer, Ear, Nose And Throat, Synthetic, Absorbable|2||N|N||874.3620|1|Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the surgeon to conform to the patient's needs.  This generic type of device is made of absorbable synthetic polymer materials.||||N|N
EN|EN|NIX|Hearing Aid, Air Conduction, Transcutaneous System|2||N|N||874.3950|1|The transcutaneous air conduction hearing aid system is a wearable sound-amplifying device that is intended to compensate for impaired hearing.  It consists of an air conduction hearing aid attached to a surgically fitted tube system.  The tube creates an air channel through the soft tissue between outer ear canal and the post-auricular region of the pinna (ear).  The air conduction hearing aid attaches to the post-auricular opening of the tube, thereby transmiting amplified sound to the ear canal without occluding the canal.||||Y|N
EN|EN|NLB|Trocar, Tracheal, Laryngeal, Sinus, Reprocessed|1||N|N||874.4420|1|Same as KBG, KAB, and KCI but need one code for reprocessing||||N|N
EN|EN|NLE|Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed|2||N|N||874.4680|1|Same as BWH except it is reprocessed||||N|N
EN|EN|NLY|Microdebrider, Ent, High Speed, Single Use, Reprocessed|1||N|N||874.4140|1|ENT microdebrider is an accessory to an ENT drill system.  It is intended to remove soft and hard tissue during ear, nost and throat surgery.  These devices operate at high speed for precise tissue resection. (this is for reprocessed sing use ENT microdebrider.)||||N|N
EN|EN|NLZ|Bur, Ent, Diamond Coated, Single Use, Reprocessed|1||N|N||874.4140|1|ENT diamond bur is an accessory to an ENT drill system.  It is intended to remove soft and hard tissue during ear, nose and throat surgery. These devices operate at high speed for precise tissue resection.||||N|N
EN|EN|NNJ|Gustometer, Non-Sterile|1||Y|N||874.1500|4|||||N|N
EN|EN|NNN|Crimper, Wire, Ent, Non-Sterile|1||Y|N||874.3540|4|Prosthesis modification instrument for ossicular replacement surgery; see product code JXT.||||N|N
EN|EN|NNO|Jig, Piston Cutting, Ent, Non-Sterile|1||Y|N||874.3540|4|Prosthesis modification instrument for ossicular replacement surgery; see product code JXY.||||N|N
EN|EN|NNP|Die, Wire Bending, Ent, Non-Sterile|1||Y|N||874.3540|4|Prosthesis modification instrument for ossicular replacement surgery; see product code JXW.||||N|N
EN|EN|NNQ|Forceps, Wire Closure, Ent, Non-Sterile|1||Y|N||874.3540|4|Prosthesis modification instrument for ossicular replacement surgery; see product code JXX.||||N|N
EN|EN|NNR|Block, Cutting, Ent, Non-Sterile|1||Y|N||874.3540|4|Prosthesis modification instrument for ossicular replacement surgery; see product code JXS.||||N|N
EN|EN|NNS|Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile|1||Y|N||874.3540|4|Prosthesis modification instrument for ossicular replacement surgery; see product code LRE.||||N|N
EN|EN|NNT|Punch,Gelfoam, Non-Sterile|1||Y|N||874.3540|4|Prosthesis modification instrument for ossicular replacement surgery; see product code JXZ||||N|N
EN|EN|NNU|Scissors, Wire Cutting, Ent, Non-Sterile|1||Y|N||874.3540|4|Prosthesis modification instrument for ossicular replacement surgery; see product code JYA.||||N|N
EN|EN|NNV|Vise, Ossicular Finger, Non-Sterile|1||Y|N||874.3540|4|Prosthesis modification instrument for ossicular replacement surgery; see product code JYB.||||N|N
EN|EN|NRK|Kit, Test, Olfactory|2||N|N||874.1600|4|The home test for loss of the sense of smell is packaged in a small carton which contains (1) an instruction book, (2) a booklet containing twelve micorencapsulated smell strips, each on a separate page, with instructions for scoring the test and an answer key, and (3) a physician information card.  The device is intended for screening neurological disorder.||||N|N
EN|EN|OGR|Ear, Nose, And Throat Surgical Tray (Kit)|1||N|N||874.4420|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
EN|EN|OGS|Myringotomy Procedure Kit|2||N|N||874.3880|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
EN|EN|OSM|Hearing Aid, Air Conduction With Wireless Technology|2||N|N||874.3305|4|Wireless hearing aids are intended as acoustic amplification devices for hearing impaired users.|The device is worn behind-the-ear or in-the-canal with audio output into the ear supported by an ear canal mold.|A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing, that incorporates wireless technology in its programming or use.|The outer ear and the ear canal.|N|N
EN|EN|PKA|External Upper Esophageal Sphincter (Ues) Compression Device|2||N|N||874.5900|1|The external UES compression device is intended to reduce the symptoms of laryngopharyngeal reflux (LPR) disease by reducing the regurgitation of stomach contents from passing through the upper esophageal sphincter.|The external UES compression device consists of an externally worn band. The band typically consists of a cushion, a comfort band, a frame, comfort dial and clasp.|The external UES compression device is worn by the patient and is designed to provide a set pressure on the cricoid cartilage, which increases the luminal pressure within the upper esophageal sphincter (UES).|An upper esophageal sphincter (UES) compression device, which applies external pressure on the cricoid cartilage right below the Adam's apple.|N|N
EN|EN|PLK|Tympanic Membrane Direct Contact Hearing Aid|2||N|N||874.3315|1|A tympanic membrane contact hearing aid is intended to compensate for impaired hearing by transmitting amplified sound by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane.|A tympanic membrane contact hearing aid consists of an externally worn audio processor, and a custom fitted tympanic membrane receiver/transducer.|A tympanic membrane contact hearing aid is a device worn by the patient that uses an external audio processor to transmit amplified sound by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane|A tympanic membrane contact hearing aid provides direct, mechanical vibration of the lateral side of the tympanic membrane.|Y|N
EN|HO|NUP|Cream, Nasal, Topical, Mechanical Allergen Particle Barrier|2||N|N||880.5045|1|THE DEVICE IS INTENDED TO PROMOTE ALLEVIATION OF MILD ALLERGIC SYMPTOMS TRIGGERED BY THE INHALATION OF VARIOUS ALLERGENS.||||N|N
EN|HO|OGQ|Ear Irrigation Kit|1||N|N||880.6960|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
EN|NE|ORR|Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri|2||N|N||882.4560|1|To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite.|Software:  aquire MR images, trajectory planning, guidance regarding alignment of targeting frame with planned trajectory, confirmation of final tool position (MR compatible tools only).  Hardware:  stereotaxic frame and accessories (e.g. various diameter guide tubes, MRI-visible marking grid to facilitate identifying burr hole location on skull).|Device software receives real-time, intraoperative MR images of the brain target and the trajectory of the targeting frame attached to the patient's skull.  Software and MRIs are used to plan trajectory, guide alignment of frame with planned trajectory, and confirm final position of surgical tool (MR compatible tools only).|skull and brain|N|N
EN|NE|PGW|Ear, Nose, And Throat Stereotaxic Instrument|2||N|N||882.4560|1|Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.|Navigation computing platform with navigation software, providing interfaces for screen and input devices including a navigation sensor, a navigation instrument and a patient reference localizer.|The device measures the position of the surgical instrument and the position of the patient using a position measurement sensor.|Ear, nose and throat|N|N
EN|SU|OLL|Septal Stapler/Absorbable Staples|2||N|N||878.4750|1|To approximate soft tissues by means of absorbable staples delivered via a pre-loaded stapler delivery system for use during nasal septal surgery, with or without cartilage reinserted.  To connect internal nasal tissues to aid healing during nasal septum reconstruction.|Resorbable polymer (e.g., poly(L-lactide-co-glycolide) with a size of approximately 5 mm X 2.5 mm X 0.5 mm thick.|Resorbable fixation devices are delivered via a pre-loaded manual surgical stapler delivery system.|Nasal septum.|Y|N
EN||EPG|Stimulator, Transdermal|3||N|N|||2|||||N|N
EN||ESI|Polymer, Natural-Absorbable Gelatin Material|3||N|N|||2|||||N|N
EN||EWD|Protector, Hearing (Insert)|U|1|N|N|||4|||||N|N
EN||EWE|Protector, Hearing (Circumaural)|U|1|N|N|||4|||||N|N
EN||FWN|Prosthesis, Larynx (Stents And Keels)|U|1|N|N|||1|||||N|N
EN||LEZ|Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)|U|1|N|N|||4|||||N|N
EN||LFA|Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)|U|1|N|N|||4|||||N|N
EN||LFB|Button, Nasal Septal|U|1|N|N|||1|||||Y|N
EN||LRA|Hearing Aid, Tactile|U|1|N|N|||1|||||N|N
EN||LWI|Ultrasound, Sinus|U|1|N|N|||1|||||N|N
EN||LXV|Apparatus, Vestibular Analysis|U|1|N|N|||1|||||N|N
EN||MCM|Implant, Cochlear|3||N|N|||2|||||Y|N
EN||MHE|Implant, Auditory Brainstem|3||N|N|||2|||||Y|N
EN||MJV|Device, Inflation, Middle Ear|U|1|N|N|||1|||||N|N
EN||MPV|Implant, Hearing, Active, Middle Ear, Partially Implanted|3||N|N|||2|||||Y|N
EN||MRK|System, Imaging, Fluorescence|3||N|N|||2|||||N|N
EN||OAA|Aid, Visual, For Nausea|N|6|N|N|||7|To relieve the symptoms associated with motion sickness.|camera, monitor, transparency|A camera and monitor or transparency are configured in such a manner so that the motion in the image as perceived by the passenger when the vehicle moves matches the motion felt by that passenger.|auditory vestibule|N|N
EN||OAF|Implant, Hearing, Active, Middle Ear, Totally Implanted|3||N|N|||2|Intended to provide useful hearing to persons with sensorineural hearing loss. Indicated for adults with mild to severe sensorineural hearing loss who have a speech discrimination score greater than or equal to 60%.|All components: microphone, sensor, electronics, audio processor, battery and driver are hermetically sealed inside the housing and implanted.  Programming accessories are separate.|surgically implanted|Mastoid bone|Y|N
EN||OAQ|Electronic Media, Hyperacusis|N|6|N|N|||7|To improve sound tolerances.|compact disc|Compact disc containing broadband pink noise.|brain|N|N
EN||OGU|Pierced Ear/Entry Cleaning Tray|N|6|N|N|||7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|Contents typically includes:  Ear piercing instrument, alcohol prep pads (pro code: LKB - unclassified), ear piercing studs.  This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|Contents typically includes:  Ear piercing instrument, alcohol prep pads (pro code: LKB - unclassified), ear piercing studs.  This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|Contents typically includes:  Ear piercing instrument, alcohol prep pads (pro code: LKB - unclassified), ear piercing studs.  This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
EN||OWO|Drug-Eluting Sinus Stent|3||N|N|||2|Mechanically maintain patency following ethmoid sinus surgery. By also eluting drugs, reduce the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.|Resorbable polymer coated in drug|Delivered through the nostril.|Sinus|Y|N
EN||PGQ|Hybrid Cochlear Implant|3||N|N|||2|Intended to provide electric stimulation to the mid to high frequency region of the cochlea and acoustic amplification to the low frequency regions, for patients with residual low frequency hearing sensitivity.|external sound processor, implant  (w/ receiver/stimulator and electrode array), programming software, accessories|provide electric stimulation to the mid- to high frequency region of the cochlea via implant and acoustic amplification to the low frequency regions via an external component|Head: Ear and Cochlea|Y|N
GU|CV|OAC|Plethysmograph, Air Displacement For Body Composition Analysis|2||N|Y||870.2770|1|To measure the total body volume and weight for calculating the estimated body composition (total body fat and total body lean mass).|An air-tight, dual compartment fiberglass and plexiglas chamber that the subject enters|Uses Boyle's law in conjunction with the two precisely-sized compartments to determine the volume occupied by the subject's body.  Average total body density is calculated from the weight and volume determined by the device. Empirical equations, as a function of density of known tissue types, are then used to estimate body composition parameters.|whole body|N|N
GU|CV|OBH|Monitor, Extracellular Fluid, Lymphedema, Extremity|2||N|Y||870.2770|1|Measure impedances in affected and unaffected but opposite extremity to periodically monitor the level of extracellular fluid or the differences in bioimpedance between opposing extremities for patients who have been previously diagnosed with unilateral lymphedema (that is, in one affected extremity)|Electronic black box/monitor with keypad or other interface and display having the ability to connect to four electrodes and computer|Applies a small alternating current of one or more frequencies through electrodes attached to particular locations on the skin surface of the subject's body and then measures/calculates level of bioimpedance indicated by living tissue over the area assessed|The arms and/or legs of the subject|N|N
GU|CV|OMV|Ultrasonic Body Composition Analyzer|2||N|N||870.2770|1|Intended to measure thickness of a distinctive tissue layer.  Indicated to Calculate the local thickness of a type of tissue [fat, muscle, bone, etc.] at a single location, or at various locations  on the body and via algorithms, estimate the amount of local tissue or total body tissue, respectively.|Hand-held cylindrical (or other shaped) electro/mechanical software-controlled device made of plastic and/or metal components and crystalline transducers.|Sends ultrasonic radiation produced by a piezoelectric crystal transmitter/transducer through body tissue at the site chosen and measures the speed of reflection at a piezoelectric receiver/transducer.|Any external location on the skin or designated locations on the arm, leg, abdomen, chest, etc. that are required to validate the body composition algorithm used.|N|N
GU|GU|BSS|Tube, Nasogastric|2||N|P||876.5980|1|||||N|N
GU|GU|EXA|Selector, Size, Ostomy|1||N|N||876.5900|4|||||N|N
GU|GU|EXB|Collector, Ostomy|1||N|N||876.5900|4|||||N|N
GU|GU|EXD|Irrigator, Ostomy|2||N|P||876.5895|4|||||N|N
GU|GU|EXE|Protector, Ostomy|1||N|N||876.5900|4|||||N|N
GU|GU|EXF|Bag, Bile Collecting|2||N|P||876.5010|1|||||N|N
GU|GU|EXG|Bag, Urine Collecting, Ureterostomy|1||N|N||876.5900|4|||||N|N
GU|GU|EXH|Bag, Urinary, Ileostomy|1||N|N||876.5900|4|||||N|N
GU|GU|EXI|Device, Paste-On For Incontinence, Sterile|1||N|N||876.5250|4|||||N|N
GU|GU|EXJ|Device, Incontinence, Urosheath Type, Sterile|1||N|N||876.5250|4|||||N|N
GU|GU|EXM|Truss, Umbilical|1||Y|N||876.5970|4|||||N|N
GU|GU|EXN|Support, Hernia|1||Y|N||876.5970|4|||||N|N
GU|GU|EXQ|Cystometer, Electrical Recording|2||N|N||876.1620|4|||||N|N
GU|GU|EXR|Urinometer, Mechanical|2||N|N||876.1800|4|||||N|N
GU|GU|EXS|Urinometer, Electrical|2||N|N||876.1800|4|||||N|N
GU|GU|EXX|Probe, Rectal, Non-Powered|1||N|N||876.4730|4|||||N|N
GU|GU|EXY|Uroflowmeter|2||N|N||876.1800|4|||||N|N
GU|GU|EXZ|Equipment, Photographic, For Physiologic Function Monitor|1||N|N||876.1500|4|||||N|N
GU|GU|EYA|Stylet, Ureteral|1||N|N||876.5130|4|||||N|N
GU|GU|EYB|Catheter, Ureteral, Gastro-Urology|2||N|Y||876.5130|1|||||N|N
GU|GU|EYC|Catheter, Upper Urinary Tract|2||N|Y||876.5130|1|||||N|N
GU|GU|EYD|Stirrups|1||N|N||876.4890|4|||||N|N
GU|GU|EYH|Table, Cysto, Non-Electrical|1||N|N||876.4890|4|||||N|N
GU|GU|EYI|Adaptor, Ureteral Catheter|1||N|N||876.5130|4|||||N|N
GU|GU|EYJ|Holder, Ureteral Catheter|1||N|N||876.5130|4|||||N|N
GU|GU|EYK|Connector, Ureteral Catheter|1||N|N||876.5130|4|||||N|N
GU|GU|EYN|Tray, Irrigation, Sterile|2||N|P||876.5980|1|||||N|N
GU|GU|EYQ|Garment, Protective, For Incontinence|1||Y|N||876.5920|4|||||N|N
GU|GU|EYS|Ribdam|1||N|N||876.4560|4|||||N|N
GU|GU|EYT|Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile|1||N|N||876.5250|4|||||N|N
GU|GU|EYZ|System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile|1||N|N||876.5250|4|||||N|N
GU|GU|EZB|Stylet For Catheter, Gastro-Urology|1||N|N||876.5130|4|||||N|N
GU|GU|EZC|Catheter, Coude|2||N|Y||876.5130|1|||||N|N
GU|GU|EZD|Catheter, Straight|2||N|Y||876.5130|1|||||N|N
GU|GU|EZK|Catheter, Retention Type|2||N|P||876.5980|1|||||N|N
GU|GU|EZL|Catheter, Retention Type, Balloon|2||N|Y||876.5130|1|||||N|N
GU|GU|EZM|Dilator, Esophageal (Metal Olive) Gastro-Urology|2||N|P||876.5365|4|||||N|N
GU|GU|EZN|Dilator, Catheter, Ureteral|2||N|P||876.5470|1|||||N|N
GU|GU|EZO|Urethrotome|2||N|P||876.4770|4|||||N|N
GU|GU|EZP|Rod, Colostomy|2||N|P||876.4270|4|||||N|N
GU|GU|EZQ|Pouch, Colostomy|1||N|N||876.5900|4|||||N|N
GU|GU|EZR|Cement, Stomal Appliance, Ostomy|1||N|N||876.5900|4|||||N|N
GU|GU|EZS|Appliance, Colostomy, Disposable|1||N|N||876.5900|4|||||N|N
GU|GU|EZT|Pacemaker, Bladder|3||N|N||876.5270|2|Call for PMAs 12/26/96 (61 FR 50707 (9/27/96))||||Y|N
GU|GU|EZW|Stimulator, Electrical, Implantable, For Incontinence|3||N|N||876.5270|2|PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96))||||Y|N
GU|GU|EZY|Device, Incontinence, Mechanical/Hydraulic|3||N|N||876.5280|2|PMA to be filed by 12/26/00 (65 FR 57731 (9/26/00))||||Y|N
GU|GU|FAD|Stent, Ureteral|2||N|Y||876.4620|1|||||Y|N
GU|GU|FAE|Prosthesis, Penile|2||N|N||876.3630|1|||||Y|N
GU|GU|FAF|Prosthesis, Testicular|3||N|N||876.3750|2|Call for PMAs on 7/5/95 per 60 FR 17216 on 4/5/95||||Y|N
GU|GU|FAH|Dilator, Urethral, Mechanical|2||N|P||876.5520|1|||||N|N
GU|GU|FAJ|Cystoscope And Accessories, Flexible/Rigid|2||N|Y|M|876.1500|1|To examine and perform procedures within the urinary tract.|endoscope, accessories associated with cystoscope|Intrument guided through urethra for visualization and to perform various procedures.|bladder, urethra, kidneys|N|N
GU|GU|FAK|Panendoscope (Gastroduodenoscope)|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FAL|Panendoscope (Urethroscope)|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FAM|Sigmoidoscope And Accessories, Flexible/Rigid|2||N|Y|M|876.1500|1|to examine and perform procedures within the sigmoid (descending) colon|endoscope, accessories associated with sigmoidoscope|instrument guided through rectum into the large intestine|sigmoid (descending) colon|N|N
GU|GU|FAN|Sigmoidoscope, Rigid, Electrical|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FAP|Cystometric Gas (Carbon-Dioxide) On Hydraulic Device|2||N|N||876.1620|4|||||N|N
GU|GU|FAQ|Bag, Urine Collection, Leg, For External Use, Sterile|1||N|N||876.5250|4|||||N|N
GU|GU|FAR|Unit, Electrosurgical|2||N|Y||876.4300|1|||||N|N
GU|GU|FAS|Electrode, Electrosurgical, Active, Urological|2||N|Y||876.4300|1|||||N|N
GU|GU|FAT|Bougie, Esophageal, And Gastrointestinal, Gastro-Urology|2||N|P||876.5365|4|||||N|N
GU|GU|FAX|Bougie, Urological|1||N|N||876.5520|4|||||N|N
GU|GU|FBI|Rongeur, Cystoscopic|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FBJ|Cord, Electric For Transurethral Surgical Instrument|2||N|Y||876.4300|1|||||N|N
GU|GU|FBK|Endoscopic Injection Needle, Gastroenterology-Urology|2||N|Y|M|876.1500|1|inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.|needle and accessories to needle. does not include pneumoperitoneum needles|instrument guided through endoscope to puncture desired tissue|gi and gu tissues|N|N
GU|GU|FBM|Cannula And Trocar, Suprapubic, Non-Disposable|1||N|N||876.5090|4|||||N|N
GU|GU|FBN|Choledochoscope And Accessories, Flexible/Rigid|2||N|Y|M|876.1500|1|to examine and perform procedures within the bile ducts.|endoscope, accessories associated with choledochoscope|instrument guided laparoscopically or through the esophagus into the biliary tree|bile ducts|N|N
GU|GU|FBO|Cystourethroscope|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FBP|Telescope, Rigid, Endoscopic|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FBQ|Trocar, Gastro-Urology|2||N|N||876.5090|4|||||N|N
GU|GU|FBR|Urethrometer|1||N|N||876.5520|4|||||N|N
GU|GU|FBS|Sound, Metal, Interconnected|1||N|N||876.4590|4|||||N|N
GU|GU|FBW|Filiform And Filiform Follower|1||N|N||876.5520|4|||||N|N
GU|GU|FBX|Sound, Urethral, Metal Or Plastic|1||N|N||876.5520|4|||||N|N
GU|GU|FCB|Bag, Hemostatic|2||N|P||876.5980|1|||||N|N
GU|GU|FCC|Endscopic Magnetic Retriever|2||N|Y|M|876.1500|1|to endoscopically retrieve magnetic foreign objects|magnetic retriever|place through endoscope to attract, capture, and remove magnet foreign bodies|magnetic foreign bodies in gi and gu tract|N|N
GU|GU|FCE|Enema Kit, (For Cleaning Purpose)|1||Y|N||876.5210|4|||||N|N
GU|GU|FCF|Instrument, Biopsy, Mechanical, Gastrointestinal|2||N|Y|M|876.1075|1|||||N|N
GU|GU|FCG|Biopsy Needle Kit|2||N|Y|M|876.1075|1|||||N|N
GU|GU|FCH|Tray, Biopsy, Without Biopsy Instruments|1||N|N||876.4730|4|||||N|N
GU|GU|FCI|Punch, Biopsy|2||N|Y|M|876.1075|1|||||N|N
GU|GU|FCK|Instrument, Biopsy, Suction|2||N|Y|M|876.1075|1|||||N|N
GU|GU|FCL|Forceps, Biopsy, Non-Electric|1||N|N||876.1075|4|||||N|N
GU|GU|FCM|Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)|2||N|Y||876.5130|1|||||N|N
GU|GU|FCN|Urinary Drainage Collection Kit, For Indwelling Catheter|2||N|N||876.5250|4|||||N|N
GU|GU|FCO|Box, Battery, Rechargeable|1||N|N||876.1500|4|||||N|N
GU|GU|FCP|Box, Battery, Pocket|1||N|N||876.1500|4|||||N|N
GU|GU|FCQ|Light Source, Incandescent, Diagnostic|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FCR|Light Source, Photographic, Fiberoptic|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FCS|Light, Catheter, Fiberoptic, Glass, Ureteral|2||N|P||876.4020|4|||||N|N
GU|GU|FCW|Light Source, Fiberoptic, Routine|2||N|Y|M|876.1500|4|||||N|N
GU|GU|FCX|Insufflator, Automatic Carbon-Dioxide For Endoscope|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FCY|Bulb, Inflation, For Endoscope|1||N|N||876.1500|4|||||N|N
GU|GU|FCZ|Tube, Smoke Removal, Endoscopic|1||N|N||876.1500|4|||||N|N
GU|GU|FDA|Enteroscope And Accessories|2||N|Y|M|876.1500|1|To provide visualization and perform various procedures within the small intestine.|enteroscope and related accessories, may include balloon, mini-scope|inserted through mouth or laparoscopically|small intestine|N|N
GU|GU|FDB|Plate, Patient|2||N|Y||876.4300|1|||||N|N
GU|GU|FDC|Resectoscope, Working Element|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FDE|Laparoscopy Kit|2||N|Y|M|876.1500|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
GU|GU|FDF|Colonoscope And Accessories, Flexible/Rigid|2||N|Y|M|876.1500|1|To examine or perform procedures in the colon or rectum|endoscope, accessories associated with colonoscope|Inserted into anus|colon or rectum|N|N
GU|GU|FDG|Retractor, Fiberoptic|1||N|N||876.4530|4|||||N|N
GU|GU|FDI|Snare, Flexible|2||N|Y||876.4300|1|||||N|N
GU|GU|FDJ|Snare, Rigid Self-Opening|2||N|Y||876.4300|1|||||N|N
GU|GU|FDL|Wristlet, Patient Return|2||N|Y||876.4300|1|||||N|N
GU|GU|FDP|Apparatus, Pneumoperitoneum, Automatic|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FDR|Sphyncteroscope|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FDS|Gastroscope And Accessories, Flexible/Rigid|2||N|Y|M|876.1500|1|To examine or perform procedures in the stomach.|endoscope, accessories associated with gastroscope|Inserted orally into the stomach|stomach|N|N
GU|GU|FDT|Duodenoscope And Accessories, Flexible/Rigid|2||N|Y|M|876.1500|1|To examine the duodenum and to perform various procedures within the duodenum.|endoscope, accessories associated with duodenoscope|Inserted orally into duodenum|duodenum, esophagus|N|N
GU|GU|FDW|Esophagoscope, Rigid, Gastro-Urology|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FDX|Endoscopic Cytology Brush|2||N|Y|M|876.1500|1|To collect cells for cytological evaluation.|brush and shaft|Brush goes through endoscope to desired location and rotates to remove and collect cells.|various tissues in gi and gu tract|N|N
GU|GU|FDY|Device, Measuring, For Panendoscope|1||N|N||876.1500|4|||||N|N
GU|GU|FDZ|Attachment, Eyepiece, For Insertion Of Prescription Lens|1||N|N||876.1500|4|||||N|N
GU|GU|FEA|Attachment, Teaching, For Endoscope|1||N|N||876.1500|4|||||N|N
GU|GU|FEB|Accessories, Cleaning, For Endoscope|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FEC|Obturator, For Endoscope|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FED|Endoscopic Access Overtube, Gastroenterology-Urology|2||N|Y|M|876.1500|1|To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.|overtube|Endoscope inserted and advanced through center of device|various openings in gi and gu tract|N|N
GU|GU|FEF|Tube, Single Lumen, W Mercury Wt Balloon For Intes. Intub. &/Or Decompression|2||N|P||876.5980|1|||||N|N
GU|GU|FEG|Tube, Double Lumen For Intestinal Decompression And/Or Intubation|2||N|P||876.5980|1|||||N|N
GU|GU|FEH|Electrode, Flexible Suction Coagulator|2||N|Y||876.4300|1|||||N|N
GU|GU|FEI|Instrument, Special Lens, For Endoscope|1||N|N||876.1500|4|||||N|N
GU|GU|FEJ|Attachment, Binocular, For Endoscope|1||N|N||876.1500|4|||||N|N
GU|GU|FEM|Accessories, Photographic, For Endoscope (Exclude Light Sources)|1||N|N||876.1500|4|||||N|N
GU|GU|FEN|Device, Cystometric, Hydraulic|2||N|N||876.1620|4|||||N|N
GU|GU|FEO|Lithotriptor, Ultrasonic|2||N|N||876.4480|1|||||N|N
GU|GU|FEQ|Pump, Air, Non-Manual, For Endoscope|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FER|Anoscope And Accessories|2||N|Y|M|876.1500|1|To examine and perform procedures within the anus and rectum.|endoscope, accessories associated with anoscope such as mini-scope|Instrument inserted through anus into rectum|anus and rectum|N|N
GU|GU|FES|Recorder, External, Pressure, Amplifier & Transducer|2||N|P||876.1725|1|||||N|N
GU|GU|FET|Endoscopic Video Imaging System/Component, Gastroenterology-Urology|2||N|Y|M|876.1500|1|To allow for visualization of body cavities through an endoscope by projecting images to a monitor.|May include:  ccd camera, monitor, other software or hardware associated with video equiptment, and components from other regulations, such as a pump.|Inserted through endoscope.|various body cavities, hollow organs, and canals in gi and gu tract.|N|N
GU|GU|FEW|Catheter, Malecot|2||N|P||876.5090|1|||||N|N
GU|GU|FEX|Instrument, Catheter, Punch|1||N|N||876.5090|4|||||N|N
GU|GU|FEZ|Catheter And Tube, Suprapubic|2||N|N||876.5090|1|||||Y|N
GU|GU|FFA|Tube, Drainage, Suprapubic|2||N|P||876.5090|1|||||N|N
GU|GU|FFD|Evacuator, Bladder, Manually Operated|1||N|N||876.4370|4|||||N|N
GU|GU|FFE|System, Water Jet Catheter, Renal|2||N|N||876.4650|4|||||N|N
GU|GU|FFF|Cover, Biopsy Forceps|1||N|N||876.1075|4|||||N|N
GU|GU|FFG|Device, Urine Flow Rate Measuring, Non-Electrical, Disposable|2||N|N||876.1800|4|||||N|N
GU|GU|FFH|Collector, Urine, Pediatric, For Indwelling Catheter|2||N|N||876.5250|4|||||N|N
GU|GU|FFI|System, Alarm, Electrosurgical|2||N|Y||876.4300|1|||||N|N
GU|GU|FFK|Lithotriptor, Electro-Hydraulic|2||N|Y||876.4480|1|||||N|N
GU|GU|FFL|Dislodger, Stone, Basket, Ureteral, Metal|2||N|N||876.4680|4|||||N|N
GU|GU|FFN|Clamp, Non-Electrical|1||N|N||876.4730|4|||||N|N
GU|GU|FFO|Retractor, Self-Retaining|1||N|N||876.4730|4|||||N|N
GU|GU|FFP|Dilator, Rectal|1||N|N||876.5450|4|||||N|N
GU|GU|FFQ|Speculum, Rectal|1||N|N||876.4730|4|||||N|N
GU|GU|FFR|Device, Locking, For Intestinal Clamp|1||N|N||876.4730|4|||||N|N
GU|GU|FFS|Image, Illumination, Fiberoptic, For Endoscope |2||N|Y|M|876.1500|1|||||N|N
GU|GU|FFT|Electrode, Ph, Stomach|1||N|N||876.1400|4|||||N|N
GU|GU|FFW|String And Tubes, Gastrointestinal, To Locate Internal Bleeding|2||N|P||876.5980|1|||||N|N
GU|GU|FFX|System, Gastrointestinal Motility (Electrical)|2||N|P||876.1725|1|||||N|N
GU|GU|FFY|Adaptor, Bulbs, Miscellaneous, For Endoscope|1||N|Y||876.1500|4|||||N|N
GU|GU|FFZ|Cord, Electric, For Endoscope|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FGA|Kit, Nephroscope|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FGB|Ureteroscope And Accessories, Flexible/Rigid|2||N|Y|M|876.1500|1|To perform various diagnostic and therapeutic procedures within the urinary tract.|endoscope, associated accessories|Inserted into blood urinary tract through urethra|urinary tract|N|N
GU|GU|FGC|Urethroscope|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FGD|Catheter, Retention, Barium Enema With Bag|2||N|N||876.5980|4|||||N|N
GU|GU|FGE|Catheter, Biliary, Diagnostic|2||N|N||876.5010|1|||||Y|Y
GU|GU|FGF|Catheter, Ureteral Disposable (X-Ray)|2||N|Y||876.5130|1|||||N|N
GU|GU|FGH|Catheter, Double Lumen Female Urethrographic|2||N|Y||876.5130|1|||||N|N
GU|GU|FGI|Catheter, Urethrographic, Male|2||N|Y||876.5130|1|||||N|N
GU|GU|FGK|Tripsor, Stone, Bladder|2||N|Y|M|876.4500|1|||||N|N
GU|GU|FGM|Probe And Director, Gastro-Urology|1||N|N||876.4730|4|||||N|N
GU|GU|FGN|Retractor, Non-Self-Retaining|1||N|N||876.4730|4|||||N|N
GU|GU|FGO|Dislodger, Stone, Flexible|2||N|N||876.4680|4|||||N|N
GU|GU|FGS|Carrier, Sponge, Endoscopic|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FGW|Clamp, Electrical|2||N|Y||876.4300|1|||||N|N
GU|GU|FGX|Snare, Non-Electrical|1||N|N||876.4730|4|||||N|N
GU|GU|FHA|Clamp, Penile|1||N|Y|M|876.5160|4|||||N|N
GU|GU|FHB|Hook, Gastro-Urology|1||N|N||876.4730|4|||||N|N
GU|GU|FHC|Adaptor To The Cord, For Transurethral Surgical Instrument|2||N|Y||876.4300|1|||||N|N
GU|GU|FHF|System, Evacuator, Fluid|2||N|N||876.4370|4|||||N|N
GU|GU|FHH|Crusher, Spur, Colostomy|1||N|N||876.4730|4|||||N|N
GU|GU|FHI|Ring, Laparotomy|1||N|N||876.4730|4|||||N|N
GU|GU|FHK|Spreader, Bladder Neck|1||N|N||876.4730|4|||||N|N
GU|GU|FHL|Scoop|1||N|N||876.4730|4|||||N|N
GU|GU|FHN|Ligator, Hemorrhoidal|2||N|P||876.4400|4|||||N|N
GU|GU|FHO|Pneumoperitoneum Needle|2||N|Y|M|876.1500|1|For establishment of a pneumoperitoneum in abdomen.|May include:  needle, stylet, housing handle.|Instrument inserted into abdomen and gasses or fluids are passed into needle to inflate the abdominal cavity.|abdominal cavity|N|N
GU|GU|FHP|Needle, Pneumoperitoneum, Simple|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FHQ|Holder, Needle, Gastroenterologic|1||N|N||876.4730|4|||||N|N
GU|GU|FHS|Dialyzer, Single Coil|2||N|N||876.5820|1|||||N|Y
GU|GU|FHT|Set, Gavage, Infant, Sterile|2||N|P||876.5980|1|||||N|N
GU|GU|FHW|Device, Impotence, Mechanical/Hydraulic|3||N|N||876.3350|2|PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))||||Y|N
GU|GU|FHX|Jelly, Lubricating, For Transurethral Surgical Instrument|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FHY|Jelly, Contact, For Transurethral Surgical Instrument|2||N|Y||876.4300|1|||||N|N
GU|GU|FHZ|Desiccator, Transurethral|2||N|Y||876.4300|1|||||N|N
GU|GU|FIA|Chair, Dialysis, Unpowered, Without Scales|1||N|N||876.5820|4|||||N|N
GU|GU|FIB|Protector, Transducer, Dialysis|2||N|N||876.5820|1|||||N|Y
GU|GU|FID|Tubing, Dialysate|2||N|N||876.5820|1|||||N|Y
GU|GU|FIE|Needle, Fistula|2||N|N||876.5540|1|||||N|N
GU|GU|FIF|Set, Dialysis, Single Needle With Uni-Directional Pump|2||N|N||876.5820|1|||||N|Y
GU|GU|FIG|Clamp, Tubing, Blood, Automatic|2||N|N||876.5820|1|||||N|Y
GU|GU|FIH|Pump, Infusion Or Syringe, Extra-Luminal|2||N|N||876.5820|1|||||N|Y
GU|GU|FII|System, Dialysate Delivery, Sealed|2||N|N||876.5860|1|||||N|Y
GU|GU|FIJ|System, Dialysate Delivery, Recirculating, Single Pass|2||N|N||876.5820|1|||||N|Y
GU|GU|FIK|System, Dialysate Delivery, Recirculating|2||N|N||876.5820|1|||||N|Y
GU|GU|FIL|System, Dialysate Delivery, Single Pass|2||N|N||876.5820|1|||||N|Y
GU|GU|FIN|Tank, Holding, Dialysis|2||N|P||876.5820|1|||||N|N
GU|GU|FIP|Subsystem, Water Purification|2||N|Y|M|876.5665|1|||||N|N
GU|GU|FIQ|Cannula, A-V Shunt|3||N|N||876.5540|1|||||Y|N
GU|GU|FIR|Pump, Blood, Extra-Luminal|2||N|N||876.5820|1|||||N|Y
GU|GU|FIS|Flowmeter, Dialysate|2||N|N||876.5820|1|||||N|Y
GU|GU|FIW|Alarm, Pillow Pressure|2||N|N||876.5820|1|||||N|Y
GU|GU|FIZ|Meter, Conductivity, Non-Remote|2||N|N||876.5820|1|||||N|Y
GU|GU|FJA|Manometer, Water|2||N|P||876.5820|1|||||N|N
GU|GU|FJB|Detector, Dialysate Level|2||N|N||876.5820|1|||||N|Y
GU|GU|FJC|Detector, Blood Level|2||N|N||876.5820|1|||||N|Y
GU|GU|FJD|Detector, Leak, Blood|2||N|N||876.5820|1|||||N|Y
GU|GU|FJF|Detector, Air Bubble|2||N|N||876.5820|1|||||N|Y
GU|GU|FJG|Dialyzer, Parallel Flow|2||N|N||876.5820|1|||||N|Y
GU|GU|FJH|Dialyzer, Disposable|2||N|N||876.5830|1|||||N|Y
GU|GU|FJI|Dialyzer, Capillary, Hollow Fiber|2||N|N||876.5820|1|||||N|Y
GU|GU|FJJ|Dialyzer, Twin Coil|2||N|N||876.5820|1|||||N|Y
GU|GU|FJK|Set, Tubing, Blood, With And Without Anti-Regurgitation Valve|2||N|N||876.5820|1|||||N|Y
GU|GU|FJL|Resectoscope|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FJM|Guard, Shunt|2||N|N||876.5540|1|||||N|N
GU|GU|FJN|Stabilizer, Shunt|2||N|N||876.5540|1|||||N|N
GU|GU|FJO|Plier, Tube|1||N|N||876.5540|1|||||N|N
GU|GU|FJP|Adaptor, Y|2||N|P||876.5820|1|||||N|N
GU|GU|FJQ|Connector, Shunt|1||N|N||876.5540|1|||||N|N
GU|GU|FJR|Forceps, Disconnect|1||N|N||876.5540|4|||||N|N
GU|GU|FJS|Catheter, Peritoneal, Long-Term Indwelling|2||N|N||876.5630|1|||||Y|N
GU|GU|FJT|Intracatheter, Dialysis|2||N|N||876.5820|1|||||N|Y
GU|GU|FJW|Ring, Joint|1||N|N||876.5540|4|||||N|N
GU|GU|FJX|Ring, Crimp|1||N|N||876.5540|4|||||N|N
GU|GU|FJY|Plier, Crimp|1||N|N||876.5540|4|||||N|N
GU|GU|FJZ|Declotting Tray, Kit (Including Contents)|2||N|P||876.5820|1|||||N|N
GU|GU|FKA|Dilator, Vessel|2||N|P||876.5540|1|||||N|N
GU|GU|FKB|Connector, Blood Tubing, Infusion T|2||N|N||876.5820|1|||||N|Y
GU|GU|FKC|Clamp, Cannula|1||N|N||876.5540|4|||||Y|N
GU|GU|FKD|Canister, Coil|2||N|N||876.5820|1|||||N|Y
GU|GU|FKE|Tie, Dialysis|1||N|N||876.5820|4|||||N|N
GU|GU|FKF|Gun, Tie, Dialysis|1||N|N||876.5820|4|||||N|N
GU|GU|FKG|Tray, Start/Stop (Including Contents), Dialysis|1||N|N||876.5820|4|||||N|N
GU|GU|FKH|Solution-Test Standard-Conductivity, Dialysis|2||N|P||876.5820|1|||||N|N
GU|GU|FKI|Set, Dialyzer Holder|2||N|P||876.5820|1|||||N|N
GU|GU|FKJ|Filter, Blood, Dialysis|2||N|N||876.5820|1|||||N|Y
GU|GU|FKK|Clamp, Line|1||N|N||876.4730|4|||||N|N
GU|GU|FKL|Insert, Pump, Blood|2||N|N||876.5820|1|||||N|Y
GU|GU|FKM|Adaptor, Fistula|2||N|P||876.5820|1|||||N|N
GU|GU|FKN|Adaptor, Shunt|2||N|N||876.5540|1|||||Y|N
GU|GU|FKO|Catheter, Peritoneal Dialysis, Single Use|2||N|N||876.5630|1|||||N|Y
GU|GU|FKP|System, Dialysate Delivery, Single Patient|2||N|N||876.5820|1|||||N|Y
GU|GU|FKQ|System, Dialysate Delivery, Central Multiple Patient|2||N|N||876.5820|1|||||N|Y
GU|GU|FKR|Subsystem, Proportioning|2||N|N||876.5820|1|||||N|Y
GU|GU|FKS|Chair, Dialysis, Powered, Without Scales|2||N|P||876.5820|1|||||N|N
GU|GU|FKT|System, Dialysate Delivery, Sorbent Regenerated|2||N|N||876.5600|1|||||N|Y
GU|GU|FKW|Tip, Vessel|3||N|N||876.5540|1|||||Y|N
GU|GU|FKX|System, Peritoneal, Automatic Delivery|2||N|N||876.5630|1|||||N|Y
GU|GU|FKY|Connector, Tubing, Dialysate|2||N|N||876.5820|1|||||N|Y
GU|GU|FLA|Monitor, Temperature, Dialysis|2||N|N||876.5820|1|||||N|Y
GU|GU|FLB|Meter, Conductivity, Induction, Remote Type|2||N|P||876.5820|1|||||N|N
GU|GU|FLC|Station, Dialysis Control, Negative Pressure Type|2||N|N||876.5820|1|||||N|Y
GU|GU|FLD|Apparatus, Hemoperfusion, Sorbent|2||N|N||876.5870|1|||||N|N
GU|GU|FOC|Bag, Urine Collection, Newborn|2||N|N||876.5250|4|||||N|N
GU|GU|FON|Bag, Drainage, With Adhesive, Ostomy|1||N|N||876.5900|4|||||N|N
GU|GU|FPD|Tube, Feeding|2||N|P||876.5980|1|||||N|N
GU|GU|FRQ|Tube, Levine|2||N|P||876.5980|1|||||N|N
GU|GU|FTI|Lamp, Endoscope, Incandescent|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FTJ|Colonoscope, General & Plastic Surgery|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FTK|Pancreatoscope, Biliary|2||N|Y|M|876.1500|1|||||N|N
GU|GU|FTO|Prosthesis, Testicle|3||N|N||876.3750|2|Call for PMAs on 7/5/95 per 60 FR 17216 on 4/5/95||||Y|N
GU|GU|FTQ|Prosthesis, Penis, Rigid Rod|2||N|N||876.3630|1|||||Y|N
GU|GU|GBL|Catheter, Ureteral, General & Plastic Surgery|2||N|Y||876.5130|1|||||N|N
GU|GU|GBM|Catheter, Urethral|2||N|Y||876.5130|1|||||N|N
GU|GU|GBT|Catheter, Rectal|2||N|P||876.5980|1|||||N|N
GU|GU|GCA|Catheter, Biliary, Surgical|2||N|P||876.5010|1|||||N|N
GU|GU|GCF|Proctoscope|2||N|Y|M|876.1500|1|||||N|N
GU|GU|GCG|Peritoneoscope|2||N|Y|M|876.1500|1|||||N|N
GU|GU|GCH|Mediastinoscope, Diagnostic|2||N|Y|M|876.1500|1|||||N|N
GU|GU|GCI|Laryngoscope, Endoscope|2||N|Y|M|876.1500|1|||||N|N
GU|GU|GCK|Gastroscope, General & Plastic Surgery|2||N|Y|M|876.1500|1|||||N|N
GU|GU|GCL|Esophagoscope, General & Plastic Surgery|2||N|Y|M|876.1500|1|||||N|N
GU|GU|GCM|Endoscope, Rigid|2||N|Y|M|876.1500|1|||||N|N
GU|GU|GCN|Endoscope, Prism|2||N|Y|M|876.1500|1|||||N|N
GU|GU|GCO|Endoscope, Mirror|2||N|Y|M|876.1500|1|||||N|N
GU|GU|GCP|Endoscope, Ac-Powered And Accessories|2||N|Y|M|876.1500|1|||||N|N
GU|GU|GCQ|Endoscope, Flexible|2||N|Y|M|876.1500|1|||||N|N
GU|GU|GCS|Endoscope, Battery-Powered And Accessories|2||N|Y|M|876.1500|1|||||N|N
GU|GU|GCT|Light Source, Endoscope, Xenon Arc|2||N|Y|M|876.1500|4|||||N|N
GU|GU|GCW|Transformer, Endoscope|2||N|Y|M|876.1500|1|||||N|N
GU|GU|GDB|Endoscope, Fiber Optic|2||N|Y|M|876.1500|1|||||N|N
GU|GU|GDS|Bag, Stomal|1||N|N||876.5900|4|||||N|N
GU|GU|JCW|Prosthesis, Penis, Inflatable|3||N|N||876.3350|2|PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))||||Y|N
GU|GU|KDH|Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration|2||N|P||876.5980|1|||||N|N
GU|GU|KDI|Dialyzer, High Permeability With Or Without Sealed Dialysate System|2||N|N||876.5860|1|||||N|Y
GU|GU|KDJ|Set, Administration, For Peritoneal Dialysis, Disposable|2||N|N||876.5630|1|||||N|Y
GU|GU|KDK|Container, Transport, Kidney|2||N|P||876.5880|1|||||N|N
GU|GU|KDL|Set, Perfusion, Kidney, Disposable|2||N|N||876.5880|1|||||N|N
GU|GU|KDM|Sigmoidoscope, Rigid, Non-Electrical|2||N|Y|M|876.1500|1|||||N|N
GU|GU|KDN|System, Perfusion, Kidney|2||N|P||876.5880|1|||||N|N
GU|GU|KDO|Rongeur, Cystoscopic, Hot|2||N|Y|M|876.1500|1|||||N|N
GU|GU|KGC|Tube, Gastro-Enterostomy|2||N|P||876.5980|1|||||N|N
GU|GU|KGD|Scissors For Cystoscope|2||N|Y|M|876.1500|1|||||N|N
GU|GU|KGE|Forceps, Biopsy, Electric|2||N|Y||876.4300|1|||||N|N
GU|GU|KLA|Monitor, Esophageal Motility, And Tube|2||N|P||876.1725|1|||||N|N
GU|GU|KNQ|Dilator, Esophageal|2||N|P||876.5365|4|||||N|N
GU|GU|KNR|Adapter, A-V Shunt Or Fistula|2||N|N||876.5540|1|||||Y|N
GU|GU|KNS|Unit, Electrosurgical, Endoscopic (With Or Without Accessories)|2||N|Y||876.4300|1|||||N|N
GU|GU|KNT|Tubes, Gastrointestinal (And Accessories)|2||N|P||876.5980|1|||||N|N
GU|GU|KNW|Instrument, Biopsy|2||N|Y|M|876.1075|1|||||N|N
GU|GU|KNX|Collector, Urine, (And Accessories) For Indwelling Catheter|2||N|N||876.5250|4|||||N|N
GU|GU|KNY|Accessories, Catheter, G-U|2||N|Y||876.5130|1|||||N|N
GU|GU|KNZ|Accessories, A-V Shunt|2||N|N||876.5540|1|||||Y|N
GU|GU|KOA|Surgical Instruments, G-U, Manual (And Accessories)|1||N|N||876.4730|4|||||N|N
GU|GU|KOB|Catheter, Suprapubic (And Accessories)|2||N|N||876.5090|1|||||Y|N
GU|GU|KOC|Accessories, Blood Circuit, Hemodialysis|2||N|N||876.5820|1|||||N|Y
GU|GU|KOD|Catheter, Urological|2||N|Y||876.5130|1|||||N|N
GU|GU|KOE|Dilator, Urethral|2||N|P||876.5520|1|||||N|N
GU|GU|KPF|System, Dialysate Delivery, Semi-Automatic, Peritoneal|2||N|N||876.5630|1|||||N|Y
GU|GU|KPH|Catheter, Rectal For Continent Ileostomy|1||N|N||876.5030|4|||||N|N
GU|GU|KPI|Stimulator, Electrical, Non-Implantable, For Incontinence|2||N|Y|M|876.5320|1|||||N|N
GU|GU|KPL|Colonic Irrigation System|2||N|N||876.5220|1|||||N|N
GU|GU|KPM|Shunt, Peritoneal|2||N|N||876.5955|1|||||Y|N
GU|GU|KPN|Alarm, Conditioned Response Enuresis|2||N|N||876.2040|4|||||N|N
GU|GU|KPO|Dialysate Concentrate For Hemodialysis (Liquid Or Powder)|2||N|N||876.5820|1|||||N|Y
GU|GU|KPP|Peritoneal Dialysate Filter|2||N|N||876.5630|1|||||N|Y
GU|GU|KQQ|Tubing, Dialysate (And Connector)|2||N|N||876.5820|1|||||N|Y
GU|GU|KQR|Detector, Air Or Foam|2||N|N||876.5820|1|||||N|Y
GU|GU|KQS|Table, Cystometric, Non-Electric And Accessories|1||N|N||876.4890|4|||||N|N
GU|GU|KQT|Evacuator, Gastro-Urology|2||N|N||876.4370|4|||||N|N
GU|GU|KXM|System Accessories, Extracorporeal|2||N|N||876.5820|1|||||N|Y
GU|GU|LBW|Set, Dialysis, Single Needle (Co-Axial Flow)|3||N|N||876.5540|1|||||Y|N
GU|GU|LCG|Intestinal Splinting Tubes|2||N|P||876.5980|1|||||N|N
GU|GU|LFJ|Catheter, Subclavian|3||N|N||876.5540|1|||||Y|N
GU|GU|LFK|Catheter, Femoral|2||N|N||876.5540|1|||||Y|Y
GU|GU|LJH|System, Irrigation, Urological|2||N|N||876.5130|1|||||N|N
GU|GU|LKY|Device, External Penile Rigidity|2||N|N||876.5020|4|Intended to create or maintain sufficient penile rigidity for sexual intercourse.  These include vacuum pumps, constriction rings, and penile splints, which are mechanical, powered or pneumatic devices.||||N|N
GU|GU|LLB|System, Blood, Extracorporeal And Accessories|2||N|N||876.5820|1|||||N|Y
GU|GU|LNS|Lithotriptor, Extracorporeal Shock-Wave,Urological|2||N|N||876.5990|1|||||N|N
GU|GU|LQC|Lithotriptor, Biliary Mechanical|2||N|Y|M|876.4500|4|||||N|N
GU|GU|LQR|Dislodger, Stone, Biliary|2||N|Y|M|876.5010|1|||||N|N
GU|GU|LRI|Ph Meter For Dialysis Hydrogen Ion Concentration|2||N|N||876.5820|1|||||N|Y
GU|GU|MJC|Catheter, Urological (Antimicrobial) And Accessories|2||N|Y||876.5130|1|||||N|N
GU|GU|MLW|Warmer, Peritoneal Dialysate|2||N|N||876.5630|1|||||N|Y
GU|GU|MMZ|Table, Cystometric, Electric|2||N|N||876.4890|4|||||N|N
GU|GU|MND|Ligator, Esophageal|2||N|P||876.4400|4|||||N|N
GU|GU|MNG|External Urethral Occluder, Urinary Incontinence-Control, Female|1||N|N||876.5160|4|Intended to prevent or decrease episodes of urine leakage in women with stress incontinence.  Occluder is applied to urinary meatus through suction or tape, which creates a barrier for urine leakage.  Occluding device such as a cap, suction cup, or foam pad. May include adhesive gel or ointment.|Occluding device such as a cap, suction cup, or foam pad. May include adhesive gel or ointment.|Occluder is applied to urinary meatus through suction or tape, which creates a barrier for urine leakage.|female urinary meatus|N|N
GU|GU|MNK|Endoscopic Bite Block|1||N|N||876.1500|4|To prevent patient from biting down in order to protect fragile endoscope equipment, patient's teeth and gums, and endscopist's fingers when inserting endoscope orally.|Bite block|Placed into mouth over teeth.|Mouth|N|N
GU|GU|MNL|Accessories, Cleaning Brushes, For Endoscope|1||N|N||876.1500|4|||||N|N
GU|GU|MNV|Strip, Dialysate Ph Indicator|2||N|P||876.5820|1|||||N|N
GU|GU|MON|System, Hemodialysis, Remote Accessories|1||N|N||876.5820|4|||||N|N
GU|GU|MPB|Catheter, Hemodialysis, Non-Implanted|2||N|N||876.5540|1|||||N|Y
GU|GU|MQS|System, Hemodialysis, Access Recirculation Monitoring|2||N|N||876.5820|1|||||N|Y
GU|GU|MSB|System And Accessories, Isolated Heart, Transport And Preservation|2||N|N||876.5880|1|||||N|N
GU|GU|MSD|Catheter, Hemodialysis, Implanted|2||N|N||876.5540|1|||||Y|Y
GU|GU|MSE|Hemodialyzer, Re-Use, Low Flux|2||N|N||876.5820|1|||||N|Y
GU|GU|MSF|Hemodialyzer, Re-Use, High Flux|2||N|N||876.5860|1|||||N|Y
GU|GU|MSY|Strip, Test, Reagent, Residuals For Dialysate, Disinfectant|2||N|N||876.5665|1|||||N|N
GU|GU|MSZ|Strip, Test, Reagent, Residuals For Dialysate|2||N|N||876.5665|1|||||N|N
GU|GU|MYE|System,Electrogastrography(Egg)|2||N|N||876.1735|1|||||N|N
GU|GU|NAM|Stimulator,Peripheral Nerve,Non-Implanted,For Pelvic Floor Dysfunction|2||N|N||876.5310|1|||||N|N
GU|GU|NDS|Media, Culture, Ex Vivo, Tissue And Cell|2||N|N||876.5885|1|||||N|N
GU|GU|NEZ|System, Imaging, Gastrointestinal, Wireless, Capsule|2||N|N||876.1300|1|||||N|N
GU|GU|NFK|Kit, Repair, Catheter, Hemodialysis|2||N|N||876.5540|1|Hemodialysis Tray|Hemodialysis Tray|Hemodialysis Tray|Hemodialysis Tray|N|Y
GU|GU|NHV|System, Water Purification, General Medical Use|2||N|N||876.5665|1|The device is a portable water treatment system which features components and technology similar to water treatment systems previously cleared for hemodialysis.  The difference lies with the intended use, as the proposed device is not intended for use in hemodialysis applications, for which a product code currently exists.  Instead, the proposed device is intended for use to purify water for general purposes, including washing of surgeons hands, surgical instruments, and wound cleansing.||||N|N
GU|GU|NIE|Catheter, Hemodialysis, Triple Lumen, Non-Implanted|2||N|N||876.5540|1|Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.||||N|Y
GU|GU|NIF|Catheter, Hemodialysis, Triple Lumen, Implanted|3||N|N||876.5540|1|Long-term (> 30 days) central venous access for hemodialysis, and apheresis, with a third lumen for infusion.||||Y|Y
GU|GU|NLM|Laparoscope, General & Plastic Surgery, Reprocessed|2||N|N||876.1500|1|The "Endoscope and accessories, reprocessed" is intended to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.  This device is indicated for reuse/reprocessing.||||N|N
GU|GU|NLR|Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed|2||N|N||876.4300|1|This device is intended to be used endoscopically to remove tissue and control bleeding by use of high frequency electrical current.  This device is indicated for reuse/reprocessing.||||N|N
GU|GU|NLS|Instrument, Biopsy, Reprocessed|2||N|N||876.1075|1|Intended to obtain samples of tissue by cutting and/or other mechanical means.  This device is indicated for reuse/reprocessing.||||N|N
GU|GU|NLT|Snare, Flexible, Reprocessed|2||N|N||876.4300|1|Intended to be used endoscopically to snare tissue in preparation for application of electrosurgical current.  This device is indicated for reuse/reprocessing.||||N|N
GU|GU|NLU|Forceps, Biopsy, Electric, Reprocessed|2||N|N||876.4300|1|The "forceps, biopsy, electric, reprocessed" are intended to be used endoscopically and use electric current to (1) obtain tissue samples for histopathological examination, (2) allow for coagulation so as to prevent bleeding, and (3) destroy the residuum of the lesion being biopsied.  This device is indicated for reuse/reprocessing.||||N|N
GU|GU|NLV|Electrode, Flexible Suction Coagulator, Reprocessed|2||N|N||876.4300|1|The "electorde, flexible suction coagulator, reprocessed" is intended to be used endoscopically to provide simultaneous suction of fluids and coagulation of tissue.  This device is indicated for reuse/reprocessing.||||N|N
GU|GU|NLW|Electrode, Electrosurgical, Active, Urological, Reprocessed|2||N|N||876.4300|1|The "electrode, electrosurgical, active, urological, reprocessed" is intended to be used endoscopically to contact urologic tissue so as to allow cutting, coagulation, electrodesiccation, or cautery dessication by means of electric current.  This device is indicated for reuse/reprocessing.||||N|N
GU|GU|NLX|Needle, Pneumoperitoneum, Spring Loaded, Reprocessed|2||N|N||876.1500|1|The "needle, penum...." is intended to insufflate the peritoneal cavity with gas during endoscopic procedures.  This device is indiated for reuse/reprocessing.||||N|N
GU|GU|NML|Catheter, Biliary, Reprocessed|2||N|N||876.5010|1|same as "FGE" except being reprocessed.||||N|N
GU|GU|NMX|Needle And Needle Set, Gastro-Urology, Reprocessed|2||N|N||876.1075|1|||||N|N
GU|GU|NMY|Needle, Endoscopic, Reprocessed|2||N|N||876.1500|1|||||N|N
GU|GU|NNE|Needle, Fistula, Reprocessed|2||N|N||876.5540|1|||||N|N
GU|GU|NNG|Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed|2||N|N||876.5820|1|||||N|N
GU|GU|NNW|Bag, Urine Collection, Leg, For External Use, Non-Sterile|1||Y|N||876.5250|4|Urine collector and accessories; see product code FAQ.||||N|N
GU|GU|NNX|Device, Incontinence, Urosheath Type, Non-Sterile|1||Y|N||876.5250|4|Urine collector and accessories; see product code EXJ||||N|N
GU|GU|NNY|Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile|1||Y|N||876.5250|4|Urine collector and accessories; see product code EYT.||||N|N
GU|GU|NNZ|System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile|1||Y|N||876.5250|4|Urine collector and accessories; see product code EYZ.||||N|N
GU|GU|NOA|Device, Paste-On For Incontinence, Non-Sterile|1||Y|N||876.5250|4|Urine collector and accessories; see product code EXI.||||N|N
GU|GU|NON|Forceps, Biopsy, Non-Electric, Reprocessed|1||N|N||876.1075|1|same as procode FCL except this product is for the reprocessed device.||||N|N
GU|GU|NOO|Clamp, Dialysis Arm|1||N|N||876.5540|4|The device is a clamp used to close off needle holes in the arm of a Dialysis patient.  The clamp applies uniform pressure to the sites of needle holes in the patient's arm until the holes close.  The clamp pressure is designed to stop bleeding without causing blood clots.  This is a different type of device than those listed in the classification regulation.||||N|N
GU|GU|NQJ|Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use|2||N|N||876.5540|1|Dual lumen, non-implanted, peripheral access catheters are inserted in the peripheral arm vein and are indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.||||N|Y
GU|GU|NQT|Dislodger, Stone, Flexible, Ureteral, Reprocessed|2||N|N||876.4680|1|A ureteral stone dislodger is a device that consists of a bougie or a catheter with a special flexible tip.  It is inserted through a cystoscope and used to entrap and remove stones from the ureter.||||N|N
GU|GU|NQU|Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed|2||N|N||876.4680|1|A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip.  It is inserted through a cystoscope and used to entrap and remove stones from the ureter.||||N|N
GU|GU|NSI|System, Imaging, Esophageal, Wireless, Capsule|2||N|N||876.1300|1|THE CAPSULE IS A DISPOSABLE, INGESTIBLE CAPSULE DESIGNED TO ACQUIRE VIDEO IMAGES OF THE ESOPHAGUS.  THE CAPSULE TRANSMITS THE ACQUIRED IMAGES VIA RF COMMUNICATION CHANNEL TO A DATA RECORDER LOCATED OUTSIDE THE BODY.  THE DIAGNOSTIC IMAGING SYSTEM IS INTENDED FOR VISUALIZATION OF THE ESOPHAGUS RATHER THAN THE SMALL BOWEL.||||N|N
GU|GU|NTN|Led Light Source|2||N|Y||876.1500|4|Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals||||N|N
GU|GU|NTZ|Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator|2||N|N||876.5820|1|DEVICE PROVIDES SEMIQUANTITATIVE INDICATIONS OF PH, BICARBONATE IONS, AND GLUCOSE IN THE FINAL BICARBONATE DIALYSATE.||||N|N
GU|GU|NUB|Colonic Irrigation System, General Well Being|3||N|N||876.5220|2|Call for PMAs on 12/26/96 per 61 FR 50707 on 9/27/96 - Colon cleansing for routine general well being||||N|N
GU|GU|NVE|Washer, Cleaner, Automated, Endoscope|2||N|N||876.1500|1|THIS AUTOMATED DEVICE IS INTENDED TO BE USED TO CLEAN ENDOSCOPES.  ENDOSCOPES THAT  ARE INTENDED TO BE CLEANED BY THE AUTOMATED CLEANER SYSTEM SHOULD HAVE BEEN  PRE-CLEANED AND TESTED FOR LEAKS AND LUMEN OBSTRUCTIONS ACCORDING TO THE INSTRUMENT  MANUFACTURER'S INSTRUCTIONS AND CURRENT PROFESSIONAL PRACTICES PRIOR TO PROCESSING IN  THE SYSTEM.  THE SYSTEM INCLUDES A CHEMICAL DISPENSING SYSTEM THAT METERS OUT A  PREDETERMINED VOLUME OF DETERGENT DURING THE APPROPRIATE CLEANING CYCLE.    THE INSTRUMENT IS PLACED IN A TRAY WITH EACH LUMEN END POSITIONED IN OPPOSITE SIDES  OF THE TRAY TO ALLOW ENOUGH DETERGENT AND RINSING WATER PASS THROUGH THE LUMENS OF  THE ENDOSCOPES.||||N|N
GU|GU|NWB|Endoscope, Accessories, Narrow Band Spectrum|2||N|N||876.1500|1|Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract.|The system consists of flexible and/or ridgid scope(s), light source(s), video processor and display|Enhances visualization of specific structures and reduces obscuring effects by using narrow bands of the visible spectrum for illumination. Narrow band illumination is accomplished through the modification of broadband light sources with optical filters or using light sources with inherently limited spectra such as lasers|Limited to endoscopic systems for observation of the gastro-urological tract|N|N
GU|GU|NWI|Electrosurgical, Electrode Kit|2||N|N||876.4300|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
GU|GU|NWO|Kit, Catheter, Urinary (Exludes Hiv Testing)|2||N|N||876.5130|1|Urinary Catheterization Kit (Excludes HIV Testing)|Urinary Catheterization Kit (Excludes HIV Testing)|Urinary Catheterization Kit (Excludes HIV Testing)|Urinary Catheterization Kit (Excludes HIV Testing)|N|N
GU|GU|NWP|Kit, Catheter, Cystostomy, Suprapubic|2||N|N||876.5090|1|Suprapubic Cystostomy Catheter Kit|Suprapubic Cystostomy Catheter Kit|Suprapubic Cystostomy Catheter Kit|Suprapubic Cystostomy Catheter Kit|N|N
GU|GU|NWQ|Kit, Catheter, External, Male (Excludes Hiv Testing)|2||N|N||876.5130|1|Male External Catheterization Kit (Excludes HIV Testing)|Male External Catheterization Kit (Excludes HIV Testing)|Male External Catheterization Kit (Excludes HIV Testing)|Male External Catheterization Kit (Excludes HIV Testing)|N|N
GU|GU|NWR|Kit, Catheter, Foley (Excludes Hiv Testing)|2||N|N||876.5130|1|Foley Catheter Kit (Excludes HIV Testing)|Foley Catheter Kit (Excludes HIV Testing)|Foley Catheter Kit (Excludes HIV Testing)|Foley Catheter Kit (Excludes HIV Testing)|N|N
GU|GU|NWS|Kit, Choledochoscope, Flexible And Rigid|2||N|N||876.1500|1|Flexible and Rigid Choledochoscope Kit|Flexible and Rigid Choledochoscope Kit|Flexible and Rigid Choledochoscope Kit|Flexible and Rigid Choledochoscope Kit|N|N
GU|GU|NWT|Kit, Cholangiogram, Endoscopic|2||N|N||876.1500|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
GU|GU|NWU|Kit, Introducer, Endoscope|2||N|N||876.1500|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
GU|GU|NYU|Catheter, Hemodialysis, Implanted, Coated|3||N|N||876.5540|1|Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.|Tube of plastic|Circulates blood from the vascular system to a hemodialysis machine.  The coatings on the catheter reduce infection or thrombosis by local affects on the blood|Central venous system|Y|Y
GU|GU|NZA|Accessories, Germicide, Cleaning, For Endoscopes|2||N|N||876.1500|1|High level disinfection of reusable, heat-sensitive devices|High level disinfection of reusable, heat-sensitive devices|High level disinfection of reusable, heat-sensitive devices|High level disinfection of reusable, heat-sensitive devices|N|N
GU|GU|NZU|Collector, Urine, Powered, Non Indwelling Catheter|1||Y|N||876.5250|4|For the non-invasive, non-sterile collection of urine and for patients unable to void on their own or have control of voiding.  Often patient confined to the bed or a wheelchair.|The device consists of a female designed cup, male cup, collection tubing, urine bag, pump, rechargeable batter, circuitry to control the operaton of the pump, software, and carrying case to be attached to a wheel chair or beside.|Urine is collected in a collection cup and with the assistance of a battery powered pump the urine is drawn through tubing into a urine bag for storage.|The collection cup is place under the external meatus of the urethra|N|N
GU|GU|OCS|Endoscopic Video Imaging System/Component, Gastroenterology-Urology|2||N|N||876.1500|1|To allow for visualization of body cavities through an endoscope by projecting images to a monitor.|May include: ccd camera, monitor, other software or hardware associated with video equipment, and components from other regulations, such as a pump.|Inserted through endoscope|various body cavities, hollow organs, and canals in GI and GU tract|N|N
GU|GU|OCT|Anti Fog Solution And Accessories, Endoscopy|2||N|Y||876.1500|1|To prevent, reduce or eliminate condensation (fog) on endoscopic lens.|anti fog solution; applicator- typically a foam pad or sponge, spray can, bottle, or cloth; container to hold solution|Apply solution to lens, typically by spraying or wiping.|endoscopic lens|N|N
GU|GU|OCU|Endoscopic Storage Cover|2||N|Y||876.1500|1|To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization.|cover or sheath|Placed over endoscope or parts of the endoscope.|delicate parts of endoscope|N|N
GU|GU|OCV|Endoscope Holder|2||N|P||876.1500|1|To hold endoscope in a desired position during procedures.|holder|endoscope placed or mounted onto holder|endoscope|N|N
GU|GU|OCW|Endoscopic Tissue Approximation Device|2||N|Y||876.1500|1|To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.|may include: delivery instrument, applier, holder, connector, threading tool, needle-loading tool, ring implant, pin implant, knot pusher, sutures, staples, clips, tackers, fasteners|Many methods to perform intended use. Insert instrument through endoscope at desired area of delivery.|Various tissues located within body cavities, hollow organs, and canals in GI and GU tract.|N|N
GU|GU|OCX|Endoscopic Irrigation/Suction System|2||N|Y||876.1500|1|To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.|may include: pump, motor, tubing, controller, air switch, power supply, transducer, digital display, suction attachment, bottle cap|Connects to tubing from pump and goes down working channel of endoscope|endoscope|N|N
GU|GU|OCY|Endoscopic Guidewire, Gastroenterology-Urology|2||N|Y||876.1500|1|To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.|metal guidewire with or without polymer coating, and associated guidewire accessories|placed through working channel of endoscope|various in GI and GU tract|N|N
GU|GU|OCZ|Endoscopic Grasping/Cutting Instrument, Non-Powered|2||N|Y||876.1500|1|To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.|Non-electric and non-magnetic devices. May include: grasping or retrieval forceps, biopsy forceps or other sampling tools, scissors, stone basket, stone dislodger|Place through an endoscope to reach desired area.|various tissues, stones or other foreign bodies within GI and GU tract.|N|N
GU|GU|ODA|Endoscopic Central Control Unit|2||N|N||876.1500|1|To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.|may include: monitor, remote (or other wireless device), microphone, card adaptor, cables, other hardware and software|Connect operating systems into central control unit|endoscopic and other ancillary surgical equipment|N|N
GU|GU|ODB|Endoscopic Contamination Prevention Sheath|2||N|N||876.1500|1|To protect an endoscope from contamination by providing a barrier between the body and the endoscope.|sheath|Placed over endoscope before insertion into the body|endoscope|N|N
GU|GU|ODC|Endoscope Channel Accessory|2||N|Y||876.1500|1|To give the endoscope channel additional or improved functionality.|may include: biopsy cover, biopsy cap, external accessory channel, anti splatter device, locking device,|attach to endoscope channel|endoscope channel|N|N
GU|GU|ODD|Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula|2||N|N||876.1500|1|To identify stones, tumors, or narrowing in the biliary tree.|catheter. may include radiopaque markings|Passed through an endoscope (duodenoscope) into the biliary duct to inject x-ray contract media into the biliary tree.|biliary tree|N|N
GU|GU|ODE|Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)|2||N|N||876.1500|1|To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant.|may include: capsule assembly, needle assembly, guidewire, suture cutter, tubing, clip delivery device, clips or other implant, plication instrument, overtube, retractor|Place sutures in soft tissue of stomach and esophagus, or deliver implant in stomach near gastroesophageal junction|gastroesophageal junction GEJ|Y|N
GU|GU|ODF|Mini Endoscope, Gastroenterology-Urology|2||N|N||876.1500|1|To examine and perform procedures in body cavities of the GI and GU tract.|May include: handle, scope, fiberoptic attachment. Usually modular in nature. May be custom built|Can be placed through working channel of a full sized endoscope. May also be used as a stand alone device|various body cavities in the GI and GU tract|N|N
GU|GU|ODG|Endoscopic Ultrasound System, Gastroenterology-Urology|2||N|N||876.1500|1|To provide ultrasonic visualization of body cavities that can be accessed by endoscope.|ultrasound system and system accessories, endoscope|Uses ultrasound to visualize body cavities through endoscope|various body cavities, hollow organs, and canals in GI and GU tract|N|N
GU|GU|ODX|Autonomous Extracorporeal Blood Leak Detector/Alarm|2||N|N||876.5820|1|To detect the presence of blood leaking from an extracorporeal connection or needle site in hemodialysis patients and alert the user or attending staff.  The device detects colormetric, chemical, or light modulation caused by exposure to leaking blood.|Small electronic, microprocessor assisted "black box" with a strap that is attached to the patient's arm.  The device has visual indicators with accompanying audible alarm|An optical fiber is connected to an infrared source at one end and an infrared receiver at the other end.  In the middle of the fiber is a sharp bend that is covered with an absorbent pad.  Blood absorbed into the pad will cause the intensity of infrared source to decrease at the receiver end and activate an alarm.|Usually the forearm but could be placed anywhere a blood line and needle are attached to the body.|N|N
GU|GU|OHR|Catheter Care Tray (Kit)|2||N|N||876.5130|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
GU|GU|OLH|Orchidometer|1||N|N||876.4730|4|To measure testicular volume to diagnose abnormalities, or to determine the size of testicular prosthesis to implant.|The orchidometer consists of a set of oval beads of various known volumes.|To the patients testes to oval beads of known volume.|The orchidometer is held next to the patient's scrotum.|N|N
GU|GU|ONJ|Dissolvable Gel For Preventing Ureteral Stone Migration|2||N|N||876.4680|4|For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures.|The device is an injectable gel that is capable of being dissolved using endoscopic irrigation.|The gel temporarily obstructs the ureter to limit the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures.  After the lithotripsy procedure, the gel is dissolved using irrigation.|The target area is the ureter.|N|N
GU|GU|ONW|Hemodialysis System For Home Use|2||N|N||876.5860|1|To treat and provide hemodialysis therapy at home for chronic renal failure patients.|Complex machine consisting of pumps, monitors, and tubing.|A machine that dialyzes the patient's blood.|Connects to the patient's blood stream|N|N
GU|GU|OOW|Applicator For Rectal Suppository|1||N|Y||876.4730|4|Intended for use in the insertion of suppositories into the rectum|plastic, non-sterile, single use plunger movably coupled with a barrel.|plastic, non-sterile, single use plunger movably coupled with a barrel.|rectal insertion|N|N
GU|GU|OQT|Prostate Lesion, Documentation, System|2||N|N||876.2050|1|Produces an elasticity image of the prostate to document prostate abnormalities that were previously identified by digital rectal examination.|Cart-based system consisting of a hand-held rectal probe attached to a computer with proprietary image reconstruction software.|Uses an array of pressure sensors and image reconstruction software to create a 3-D map showing areas of relative tissue hardness or softness within the prostate.|Prostate, rectum.|N|N
GU|GU|PBP|Rectal Insert|2||N|N||876.5980|1|Acts as a barrier to the passage of fecal matter through the rectum.|Comprised of a silicone Insert and a plastic fingertip applicator.  The Insert has a barbell shape, the end which sits inside of the rectum ranges in size from 22 mm to 28 mm in width.  The Insert is 35 mm long and the external flare is 24 mm.|Designed for self-insertion to seal and prevent the involuntary leakage of stool from the rectum.|To be placed across the anal sphincter.|N|N
GU|GU|PCU|Pancreatic Stent, Covered, Metallic, Removable|2||N|N||876.5015|1|To facilitate transmural endoscopic drainage of pancreatic pseudocysts|stent and delivery system, endoscope|Facilitates and secures the apposition of tissue for transmural placement of stent|pancreatic pseudocysts adherent to bowel wall|Y|N
GU|GU|PCV|Endoscopic Leak Tester|2||N|N||876.1500|1|To be used to perform and record leakage testing on flexible endoscopes.|The test results are displayed on an LCD monitor. In the MLT mode, the operator determines whether the endoscope has a pinhole by monitoring air bubbles from the endoscope soaked in water. It also uses RFID for recognizing endoscopes and operators and has a recording function to store test results for printing as needed. It has a guiding function and self-check function.|The tester uses two testing modes: (1) automated leak test mode (ALT mode), (2) manual leak test mode (MLT mode). The device detects leaks from the differences in air pressure.|flexible endoscopes.|N|N
GU|GU|PEA|Endoscope, Accessories, Image Post-Processing For Color Enhancement|2||N|N||876.1500|1|Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.|The system consists of flexible and/or rigid scope(s), light source(s), video processor and display.|Image enhancement using image post-processing algorithms of the received white light image with the goal of enhancing visualization of suspicious images seen on white light.|Limited to endoscopic systems for observation of the gastro-urological tract.|N|N
GU|GU|PEH|Hemodialysis Catheter Luer End Cap|2||N|N||876.5540|1|For use in hemodialysis catheters to reduce hub infection.|Plastic end cap with rod attached|Antimicrobial agent adhered to rod and lock ring of end cap. End cap has a rod which extends into the hub of the hemodialysis catheter to aid in delivering antimicrobial agent|Implanted blood access device|N|N
GU|GU|PEV|Dialysis Administration Kits (Convenience Kit)|2||N|N||876.5820|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
GU|GU|PEW|Implantable Transprostatic Tissue Retractor System|2||N|N||876.5530|1|The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.|Comprises two main components, the delivery device and implant. Each delivery device comes pre-loaded with one I\implant. The delivery device is inserted into a 20F cystoscopy sheath which has been placed in the male urethra with the sheath tip located within the bladder. After insertion into the sheath, the tip of the device is positioned in the prostatic urethra and used to retract an obstructing prostatic lobe. An implant is then deployed transversely through the urethra into the prostatic tissue. The implant is secured to maintain the retracted position of the lobe. Implants are deployed thereby maintaining an expanded urethral lumen.|Delivered transurethrally using a rigid delivery device which is used to displace the urethra towards the prostatic capsule. The implants then maintain the approximated position of the inner (urethral) tissue and the outer (capsular) tissue of the prostate thereby reducing fluid obstruction and improving LUTS.  The displaced urethra then provides increased urethral opening.  The biological mechanism of action is localized transient tissue compression leading to lobular atrophy. Once lobular atrophy has been obtained, the static implant imparts no further mechanical stimulation on the tissue, and tissue remodeling is complete.|Prostate|Y|N
GU|GU|PFH|Venous Window Needle Guide|2||N|N||876.5540|1|For use as an access device accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site or buttonhole method of needle insertion.|It is comprised of a port or septum that permits passage of a needle.|Implanted and attached to a vessel, permitting guide for insertion of a needle into the vessel.|Blood vessel|Y|Y
GU|GU|PGD|Colon Capsule Imaging System|2||N|N||876.1330|1|visualization of the colon for the detection of polyps|capsule|The device is a single-use ingestible capsule designed to acquire video images during natural propulsion through the digestive system. It is specifically designed to visualize the complex anatomy of the colon|colon|N|N
GU|GU|PGU|Spatial Imaging For Display Of Endoscope Position|2||N|N||876.1500|1|To detect and display the shape of an inserted endoscope.|A control unit that communicates with an endoscope/accessory probe, a receiver dish, and display monitor.|Measures electromagnetic fields from the endoscope or an accessory within an endoscope to determine the shape of an inserted endoscope, and displays it on a monitor.|Gastrointestinal system|N|N
GU|GU|PHT|Basin For Endoscope Reprocessing|1||N|N||876.1500|4|To allow endoscopes to soak in reprocessing solutions.|The device is comprised of a basin that may be molded to more closely meet the contours of a coiled endoscope. The device may include a heater and temperature monitor.|The basin may be contoured to minimize the volume of reprocessing solution used. The basin may also have a temperature control. The basin does not include flushing technology.|Flexible gastrointestinal endoscopes|N|N
GU|GU|PIA|Vibrator For Climax Control Of Premature Ejaculation|2||N|N||876.5025|1|Vibrator for climax control training for the treatment of premature ejaculation.|The device consists of a vibrator connected to a battery pack.|Battery-operated vibrator and lubricant for climax control of premature ejaculation for men|Male genitals|N|N
GU|GU|PID|Esophageal Dilator Balloon With Or Without Electrode Sensors|2||N|N||876.5980|1|To dilate the lower esophageal sphincter of patients with Achalasia.|Tube and Balloon with or without electrode sensors and software.|Tube and Balloon with or without electrode sensors.|lower esophageal sphincter|N|N
GU|GU|PIE|Esophageal Dilator With Balloon And Electrode Sensors|2||N|N||876.5980|1|To dilate esophageal strictures with a dilating balloon and electrode sensors.|balloon with electrode sensors and software|balloon with electrode sensors|esophagus|N|N
GU|GU|PIF|Gastrointestinal Tubes With Enteral Specific Connectors|2||N|N||876.5980|1|To facilitate enteral specific connections.|plastic connector|The connector is attached to an enteral tube and is intended to facilitate the administration of hydration, medication, and feed to a patient.|the gastrointestinal tract|N|N
GU|GU|PIH|Urethral Insert With Pump For Bladder Drainage|2||N|N||876.5140|1|The device is intended to empty urine from the bladder under patient control.|A catheter-like device with internal pump mechanism that is placed in the urethra.|Under patient control, the internal pump inside the urethral insert draws urine out of the bladder when voiding is desired, and blocks urine flow when continence is desired.|The device is placed in the urethra.|Y|N
GU|GU|PIN|Kidney Perfusion Kit|2||N|N||876.5880|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
GU|GU|PIO|Enteral Specific Transition Connectors|2||N|N||876.5980|1|Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.|plastic connector|A plastic connector that allows for AAMI/CN3(PS):2014 compliant connectors to connect to non ISO 80369-1 compliant legacy enteral connectors.|GI|N|N
GU|GU|PJH|Dynamic Rectal Control System|2||N|N||876.5930|1|Intended to treat fecal incontinence by controlling the size of the rectal lumen.|The device includes a balloon like device placed in the vagina and an external regulator and inflation pump to control the state of expansion.|The device is inserted in the vagina and includes a portion that expands to reduce the rectal lumen to prevent stool leakage and retracts to allow normal passage of stool.|Vaginal placement for compression of rectum|N|N
GU|GU|PKI|Fully Subcutaneous Implanted Hemodialyis Catheter|2||N|N||876.5540|1|Provides access to the blood for hemodialysis or other chronic uses.|fully subcutaneous implanted hemodialysis catheter|Provides fully subcutaneous access to the blood for hemodialysis or other cronic uses.|internal jugular or femoral veins via the skin and subcutanous tissue|Y|Y
GU|GU|PKL|Hemostatic Metal Clip For The Gi Tract|2||N|N||876.4400|1|Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations.|Metal clips applied by a delivery system|Applies pressure to tissue|Gastrointestinal tract|Y|Y
GU|GU|PLI|Gastrostomy Tube Holder|2||N|N||876.5980|1|Intended to support, secure, and hold gastrostomy tubes|Cloth material held together by fasteners|Holds gastrostomy tube in place using strap|Abdomen|N|N
GU|GU|PLL|Submucosal Injection Agent|2||N|N||876.1500|1|Intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.|Gel|submucosal injection via endoscopy|Gi tract|N|N
GU|GU|PLP|High Intensity Ultrasound System For Prostate Tissue Ablation|2||N|N||876.4340|1|Prostate tissue ablation|The system consists of a console, a probe with therapy transducer(s), and single use accessories.|Uses high intensity ultrasound to heat target tissue within the prostate gland, causing coagulation necrosis of that tissue.|The prostate gland|N|N
GU|OB|OCQ|Laparoscopic Bladder-Neck Suspension Instrument, Stress Urinary Incontinence|2||N|N||884.1720|1|For female urinary stress incontinence due to hypermobility|may include: template assembly, suture retriever, suture cutter, suture placement system|Bladder neck suspension using sutures|bladder neck|N|N
GU|PM|OAG|Garment, Storage, Peritoneal Dialysis Catheter|1||Y|N||890.5050|4|To store the external peritoneal catheter portion between treatment sessions and to support, stabilize, and improve the care and cleanliness of the peritoneal catheter and reduce the need to use tape on the skin.|Cloth belt|Holds the catheter tube in a cloth sleeve wrapped around the patient's abdomen.|External to the body around the abdomen.|N|N
GU|SU|ESW|Prosthesis, Esophageal|2||N|N||878.3610|1|||||Y|N
GU|SU|LNK|Laser For Gastro-Urology Use|2||N|N||878.4810|1|||||N|N
GU|SU|MQR|Stent, Colonic, Metalic, Expandable|2||N|N||878.3610|1|||||Y|N
GU|SU|MUK|Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue|2||N|N||878.4400|1|For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence|radiofrequency generator, applicator, software|A generator supplies radiofrequency energy through a connected applicator with an electrode tip|pelvic tissue|N|N
GU|SU|MUM|Stent,Metallic,Expandable,Duodenal|2||N|N||878.3610|1|||||Y|N
GU|SU|NEJ|System, Cryosurgical, Liquid Nitrogen, For Gastroenterology|2||N|N||878.4350|1|||||N|N
GU|SU|OTM|Mesh, Surgical, For Stress Urinary Incontinence, Male|2||N|N||878.3300|1|surgical treatment of male stress urinary incontinence post-prostatectomy|biologic (e.g., collagen) and/or synthetic (e.g, metallic or polymeric) woven fabric of varying design and material properties|permanently implantable sling placed under the urethra; during instances of increased abdominal pressure (e.g., coughing, laughing, sneezing, etc.), device applies pressure to the urethra to prevent urine leakage|bladder, urethra|Y|N
GU||EXW|Pill, Radio|U|1|N|N|||1|||||N|N
GU||EZZ|Prosthesis, Vas Deferans|3||N|N|||2|||||Y|N
GU||FAA|Replacer, Urethral|3||N|N|||2|||||Y|N
GU||FAB|Replacer, Ureteral|3||N|N|||2|||||Y|N
GU||FAC|Valve, Ureterovesicle|3||N|N|||2|||||Y|N
GU||FAG|Prosthesis, Urethral Sphincter|3||N|N|||2|||||Y|N
GU||FAO|Device, Cystometric, Air|3||N|N|||2|||||N|N
GU||FBY|Cooler, Esophageal And Gastric|3||N|N|||2|||||N|N
GU||FBZ|Cooler, Prostatic|3||N|N|||2|||||N|N
GU||FSH|Tray, Surgical, Needle|U|1|N|N|||1|||||N|N
GU||LEI|Implant, Anti-Gastroesophageal Reflux|3||N|N|||2|||||Y|N
GU||LIF|Dialyzer Reprocessing System|U|1|N|N|||1|||||N|N
GU||LIL|Monitor, Penile Tumescence|U|1|N|N|||1|||||N|N
GU||LJE|Catheter, Nephrostomy|U|1|N|N|||1|||||N|N
GU||LKN|Separator, Automated, Blood Cell And Plasma, Therapeutic|U|1|N|N|||1|||||N|N
GU||LKX|Device, Thermal, Hemorrhoids|U|1|N|N|||1|||||N|N
GU||LNL|Stimulator, Electrical For Sperm Collection|U|1|N|N|||1|||||N|N
GU||LNM|Agent, Bulking, Injectable For Gastro-Urology Use|3||N|N|||2|||||N|N
GU||LNQ|Intestinal Stimulator|f||N|N|||6|||||N|N
GU||LNR|System, Photopheresis, Extracorporeal|3||N|N|||2|||||N|N
GU||LOA|Device, Testicular Hypothermia|3||N|N|||2|||||N|N
GU||LQQ|Columns, Immunoadsorption In Extracorporeal Systems|3||N|N|||2|||||N|N
GU||LQS|Spermatocele, Alloplastic|U|1|N|N|||1|||||Y|N
GU||LRL|Cushion, Hemorrhoid|U|1|N|N|||4|||||N|N
GU||LST|Device, Erectile Dysfunction|U|1|N|N|||1|||||N|N
GU||LTI|Implant, Intragastric For Morbid Obesity|3||N|N|||2|||||Y|N
GU||LXW|Column, Adsorption, Low Density, Lipoprotein|3||N|N|||3|||||N|N
GU||MCI|Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite|3||N|N|||2|||||N|N
GU||MDP|Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma|3||N|N|||2|||||N|N
GU||MEQ|System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy|3||N|N|||2|||||N|N
GU||MER|Stent, Urethral, Prostatic, Permanent Or Semi-Permanent|3||N|N|||2|||||N|N
GU||MES|Stent, Urethral, Bulbous, Permanent Or Semi-Permanent|3||N|N|||2|||||N|N
GU||MIK|Device, Ultrasonic, Thermal Ablation|3||N|N|||2|||||N|N
GU||MIP|Implanted Fecal Incontinence Device|3||N|N|||2|PMA Approved:  P010020||||Y|N
GU||MMY|Lipoprotein, Low Density, Removal|3||N|N|||2|||||N|N
GU||MOA|Analyzer, Diagnostic, Fiber Optic (Colon)|3||N|N|||2|||||N|N
GU||MRE|Solution, Sodium Hyaluronate|3||N|N|||3|||||N|N
GU||MXQ|Stent,Urethral,External Sphincter,Permanent|3||N|N|||2|||||Y|N
GU||NAZ|Stimulator,Bladder|f||N|N|||6|||||N|N
GU||NBG|Marker,Colon|U|1|N|N|||1|||||N|N
GU||NCV|Lithotripter, Shockwave (For Treating Gallbladder Stones)|3||N|N|||2|||||N|N
GU||NKL|Molecular Adsorbent Recirculating System (Mars)|U|1|N|N|||1|The molecular adsorbent recirculating system (mars) is an albumin dialysis blood detoxification system designed for the combined removal of water-soluble low molecular weight substances and albumin-bound molecules in the treatment of acute hepatic encephalopathy due to decompensation of chronic liver disease or fulminant hepatic failure.  The mars system is also indicated for the treatment of drug overdose and poisonings.  The only requirement is that the drug or chemical be dialyzable and bound by albumin.  The mars system is not indicated for the treatment of chronic liver disease or a bridge to liver transplant.||||N|Y
GU||NYV|Gastrointestinal Motility System, Capsule|U|1|N|N|||1|Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.|Small ingestible capsule transmits motility data to a wireless receiver worn by the subject.  Data from the receiver is dowloaded into a personal computer (PC) and analyzed with custom software.|Ingestible telemetric capsule that transmits GI motility data to a wireless receiver worn by the patient.|Device is swallowed, and passes through the GI tract|N|N
GU||NZC|Stent, Urethral, Prostatic, Semi-Permanent|3||N|N|||2|Approximately 3 cm tube placed in the prostatic urethra for short term use to drain urine.  The device includes a retention mechanism that anchors in the bladder neck to hold it in place and a release mechanism that exits the penis.  For short term use in men with partial of full prostatic urethral obstruction or the prevention of prostatic urethral obstruction post surgery or other prostatic treatment.|Approximately 3 centimeter tube (i.e. length of prostatic urethra) that is inserted into the prostatic urethra and includes a proximal retention component that anchors the device in the bladder neck and a suture-type material on the distal end that exits the urethra.|The urethral stent crosses a partially or fully obstructed prostatic urethra to allow passage of urine.|Prostatic urethra.|N|N
GU||OAY|Light Source System, Diagnostic Endoscopic|3||N|N|||2|A fluorescence system intended for use as an adjunct to white light cystoscopy when used in combination with a photosensitizer for the detection of bladder cancer.  Patients with known or suspected bladder cancer and/or recurrence of bladder cancer, in patients undergoing diagnostic testing for bladder cancer by cystoscopy or positive urine cytology or who present with hematuria and/or a positive urine cytology test.|System includes a PPD light source, specific PDD telescopes for cystoscopy), camera system (PDD camera control unit, and PDD camera heads) fluid light cable, and PC based software communication program|1.	excitation and emission filters in the PDD telescopes and PDD camera heads  limit light to the blue portion of the visible spectrum The combination of these 2 filters in conjunction with the photo- fluorescent drug Hexvix? enables visualization  of carcinoma in situ (CIS) as a red fluorescent image against normal tissue that appears blue.|Urinary Bladder|N|N
GU||OCK|Transurethral Occlusion Insert, Urinary Incontinence-Control, Female|3||N|N|||2|Transurethral insert for urinary occlusion/control in women with urinary incontinence|balloon tipped catheter, insertion device|A balloon tipped catheter is inserted into the urethra. Deflation or removal of the device results in fluid movement|urethra|N|N
GU||ODH|Implantable Bladder-Evacuation Electrical Stimulation System|f||N|N|||6|To provide urination on demand and to reduce post-void residual volumes of urine in patients who have clinically complete spinal cord lesions (asia classification) with intact parasympathetic innervations of the bladder and are skeletally mature and neurologically stable.|May include: electrodes, implantable pulse gnerator, battery charger, programmer or transmitter, surgical components|electrical sacral nerve stimulation|sacral anterior root|Y|N
GU||ODN|Ultrafiltration-Controlled Nocturnal Dialysate Delivery System|3||N|N|||1|Hemodialysis performed with a high permeability hemodialyzer and an ultrafiltration-controlled system.  Nocturnal hemodialysis for patients with end-stage renal disease (chronic dialysis) or acute renal failure (acute dialysis) performed with a high permeability hemodialyzer and an ultrafiltration-controlled system.|Device is an electronic, software-controlled system with a user interface.  Device can include extracorporeal tubing sets, but not necessarily.|Device consists of a system of pumps, valves, sensors, monitors and other components that direct blood through a dialyzer so that hemodialysis may be performed.|Device is an extracorporeal device treating patients' blood.|N|Y
GU||OKN|Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy|3||N|N|||2|To heat the bladder wall concomitant with intravesical instillation of a chemotherapy drug.  For the prophylactic treatment of bladder cancer recurrence following standard resection of tumors.|A hyperthermia control unit, a transurethral treatment catheter, and connecting tubing/cables.|Uses RF/microwave energy to heat the bladder wall and the intravesical chemotherapy solution.|The urinary bladder.|N|N
GU||ONY|Oral Removable Retainer For Weight Loss|N|3|N|N|||3|A removable oral device used during meals to limit food intake|A removable oral device used during meals to limit food intake|A removable oral device used during meals to limit food intake|A removable oral device used during meals to limit food intake|N|N
GU||OVL|Hemodialyzer, High Cut-Off|f||N|N|||6|Removal of free light chains for the treatment of dialysis dependent acute renal failure secondary to cast nephropathy in patients with multiple myeloma.|The high cut-off technology hemodialyzer is characterized by larger membrane pore sizes resulting in a nominal cut off-point of 100 kilo Daltons (kDa) allowing removal of circulating substances with molecular weights up to a value of approximately 45 kDa.  The membrane material used in this device is polyarylethersulfone (PAES) with an effective membrane surface area of 2.1 m².|The high cut-off technology hemodialyzer is used on a conventional hemodialysis system with controlled ultrafiltration for the removal of free light chains.   During therapy, anticoagulated blood taken from the patient flows via a tubing system through the high cut-off technology hemodialyzer and back into the patient's vascular system.  Conventional dialysate solution is circulated in a counter-current direction through the dialysate compartment of the high cut-off hemodialyzer.  To compensate for the removed fluid volume, a physiologic and isotonic replacement fluid is infused into the patient at a flow rate equal to or less than the filtrate flow rate.|External communicating device in contact with circulating blood.|N|N
GU||PAT|Bladder System|f||N|N|||6|for the treatment of patients who have complete spinal cord lesions (ASIA Classification) with intact parasympathetic innervation of the bladder and are skeletally mature and neurologically stable, to provide urination on demand and to reduce post-void residual volumes of urine.|Implantable Receiver-Stimulator, and Extradural Electrodes; External controller (battery powered), External Transmitter, Battery Charger, Power Corc, External Cable and Transmitter Tester; Surgical component -Surgical stimulator, Extradural Surgical Probe, Intradural Surgical Probe, Electrode test Cable and Silicone adhesive.|Sacral anterior root stimulator intended to provide bladder evacuation by delivering electrical stimulation to the patient's intact spinal nerve root in order to elicit functional contraction of the muscles innervated by them. It consists of implantable, external, and surgical components.|Electrical stimulation of the urinary bladder in the Gu Tract to provide urination on demand and to reduce post-void residual volumes of urine.|Y|N
GU||PAZ|Electrical Stimulation  Bladder System|f||N|N|||6|for the treatment of patients who have complete spinal cord lesions (ASIA Classification) with intact parasympathetic innervation of the bowel and are skeletally mature and neurologically stable, to provide bowel evacuation.|Implantable Receiver-Stimulator, and Extradural Electrodes; External controller (battery powered), External Transmitter, Battery Charger, Power Cord, External Cable and Transmitter Tester; Surgical component -Surgical stimulator, Extradural Surgical Probe, Intradural Surgical Probe, Electrode test Cable and Silicone adhesive.|Sacral anterior root stimulator intended to provide bladder evacuation by delivering electrical stimulation to the patient's intact spinal nerve root in order to elicit functional contraction of the muscles innervated by them. It consists of implantable, external, and surgical components.|Electrical stimulation of the lower bowel in the GI Tract to provide fecal evacuation on demand.|Y|N
GU||PBN|Apheresis For Focal Glomerulosclerosis In Pediatric Patients|f||N|N|||6|Teatment of pediatric patients with primary focal segmental glomerulosclerosis in which standard treatment options are unsuccessful or not well tolerated or treatment of post renal transplantation pediatric patients with recurring primary focal segmental glomerulosclerosis|Composed of four components: a pair of paheresis columns (dextran sulfate cellulose adsorption column soaked in sodium citrate solution); two other disposabel components (a hollow fiber, ethylene vinyl alcohol copolymer-coated polyethylene plasma spearator and a polyvinyl chloride tubing system); and a reusable electronic control unit.|Blood is pumped from patients arm into the device which then separates blood into cellular components and plasma.  Plasma is then sent thru dextran sulfate cellulose column to remove specific plasma components.  Depleted plasma is then recombined with cellular blood elements and is then pumped back to patient.|Plasma components are removed to aid the patients kidneys|N|N
GU||PDI|Beta 2-Microglobulin Apheresis Column|f||N|N|||6|Relief of symptoms of clinically diagnosed dialysis-related amyloidosis (DRA).|The Beta 2-microglobulin Apheresis Column is an adsorbent column containing porous, spherical cellulose beads with covalently linked hexadecyl groups as ligands.  The size of the pores on the beads is about 460 um.  The device comes in multiple models with capacity ranging from 150 ml to 350 ml and extracorporeal volume ranging from 65 ml to 177 ml.|The device adsorbs Beta 2-microglobulin by the combined use of hydrophobic interaction and the appropriate pore size on cellulose beads.  The pore size limits the size of proteins and peptides adsorbed by the column to be between 4 and 20 kDa.|External communicating device in contact with circulating blood.|N|N
GU||PFE|Gastrointestinal Liner System|N|3|N|N|||3|for the treatment of type 2 diabetes. The gastrointestinal liner is indicated for a maximum of 12 months.|Grasper and Retrieval Hood|It is provided sterile and consists of a gastrointestinal liner (anchor and liner), preloaded in a catheter that delivers the liner to the proximal intestine.|GI|Y|N
GU||PHN|Protective Coating, Mucoadhesive Application, For The Rectal Mucosa|U|1|N|N|||1|Mucoadhesive application for the protective coating of the rectal mucosa.|viscous liquid|applied via enema bottle applicator, the mucoadhesive formulation results in the formation of a protective coating over the rectal mucosa.|rectum|N|N
GU||PHO|Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs|3||N|N|||6|Preservation of donor lungs for transplantation.|Device consists of a system made up of several components, such as the oxygenator, ventilator, thermal control unit, flow pumps, as well as the dedicated disposable sets, cannulation accessories, organ chamber and STEEN preservation solution.|Device actively perfuses the donor lung with a preservation solution, while also ventilating and oxygenating it, and while maintaining it in near-physiologic temperatures, so that it may be preserved and assessed for transplantation.|Donor lungs|N|Y
GU||PIK|Metabolic Neuromodulation System|N|3|N|N|||7|The device treats type 2 diabetes through hepatic nerve denervation. The metabolic neuromodulation system consists of a monopolar single electrode ablation catheter and radio frequency generator and is intended to ablate the sympathetic nerves surrounding the common hepatic artery.|The device treats type 2 diabetes through hepatic nerve denervation. The metabolic neuromodulation system consists of a monopolar single electrode ablation catheter and radio frequency generator and is intended to ablate the sympathetic nerves surrounding the common hepatic artery.|The device treats type 2 diabetes through hepatic nerve denervation. The metabolic neuromodulation system consists of a monopolar single electrode ablation catheter and radio frequency generator and is intended to ablate the sympathetic nerves surrounding the common hepatic artery.|hepatic artery.|N|N
GU||PIM|Neuromodulator For Obesity|3||N|N|||2|Weight reduction by peripheral neuromodulation.|Pulse generator with leads|Neural modulation with implantable electrical pulse generators.|Enteric nervous system|Y|N
HE|AN|PHY|Sparse Sample Pk Profile And Dosing Software|2||N|N||868.1890|1|To estimate PK profile and dosing calculation.|Solid|Software driven|Blood|N|N
HE|HE|BSA|Warmer, Blood, Electromagnetic Radiation|3||N|N||864.9205|2|||||N|N
HE|HE|BSB|Warmer, Blood, Non-Electromagnetic Radiation|2||N|N||864.9205|1|||||N|N
HE|HE|DAP|Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control|2||N|P||864.7320|1|||||N|N
HE|HE|DAR|Fibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control|2||N|N||864.7340|1|||||N|N
HE|HE|DAT|Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control|2||N|N||864.7340|1|||||N|N
HE|HE|DAX|Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control|2||N|N||864.7340|1|||||N|N
HE|HE|DAZ|Fibrinogen And Split Products, Antigen, Antiserum, Control|2||N|N||864.7340|1|||||N|N
HE|HE|DDQ|Antigen, Antiserum, Control, Antithrombin Iii|2||N|N||864.7060|1|||||N|N
HE|HE|GFK|Fibrinogen Determination Standards And Controls|2||N|P||864.7340|1|||||N|N
HE|HE|GFO|Activated Partial Thromboplastin|2||N|N||864.7925|1|||||N|N
HE|HE|GFS|Standards And Controls, Hemoglobin, Normal And Abnormal|2||N|Y||864.8625|1|||||N|N
HE|HE|GFT|Protamine Sulphate|2||N|N||864.7525|1|||||N|N
HE|HE|GFX|Fibrinogen Standard|2||N|Y||864.7340|1|||||N|N
HE|HE|GGC|Control, Plasma, Abnormal|2||N|N||864.5425|1|||||N|N
HE|HE|GGF|Acid Hematin|2||N|P||864.7500|1|||||N|N
HE|HE|GGG|Guaiac Reagent|2||N|Y||864.6550|1|||||N|N
HE|HE|GGJ|Fluid, Diluting, White-Cell|1||N|N||864.8200|4|||||N|N
HE|HE|GGK|Products, Red-Cell Lysing Products|1||N|N||864.8540|4|||||N|N
HE|HE|GGL|Control, White-Cell|2||N|Y||864.8625|1|||||N|N
HE|HE|GGM|Control, Hemoglobin|2||N|Y||864.8625|1|||||N|N
HE|HE|GGN|Plasma, Coagulation Control|2||N|N||864.5425|1|||||N|N
HE|HE|GGO|Reagent, Thromboplastin And Control|2||N|N||864.7925|1|||||N|N
HE|HE|GGP|Test, Qualitative And Quantitative Factor Deficiency|2||N|N||864.7290|1|||||N|N
HE|HE|GGQ|Test, Prothrombin Consumption|2||N|N||864.7720|7|||||N|N
HE|HE|GGT|Assay, Erythropoietin|2||N|Y||864.7250|1|||||N|N
HE|HE|GGW|Test, Time, Partial Thromboplastin|2||N|N||864.7925|1|||||N|N
HE|HE|GGX|Pipette, Sahli|1||N|N||864.6160|4|||||N|N
HE|HE|GGY|Pipette, Diluting|1||N|N||864.6160|4|||||N|N
HE|HE|GGZ|Oxyhemoglobin|2||N|P||864.7500|1|||||N|N
HE|HE|GHA|Hemoglobin, Alkali Resistant|2||N|P||864.7455|1|||||N|N
HE|HE|GHC|Tube, Sedimentation Rate|1||N|N||864.6700|4|||||N|N
HE|HE|GHD|Test, Leukocyte Alkaline Phosphatase|1||N|N||864.7660|4|||||N|N
HE|HE|GHH|Fibrin Split Products|2||N|P||864.7320|1|||||N|N
HE|HE|GHK|Centrifuge, Microsedimentation|1||N|N||864.5350|4|||||N|N
HE|HE|GHM|Test, Sickle Cell|2||N|P||864.7825|1|||||N|N
HE|HE|GHO|Hemocytometer|1||N|N||864.6160|4|||||N|N
HE|HE|GHQ|Stain, Fetal Hemoglobin|2||N|P||864.7455|1|||||N|N
HE|HE|GHR|Reagent, Platelet Aggregation|2||N|N||864.5700|1|||||N|N
HE|HE|GHS|Assay, Carboxyhemoglobin|2||N|P||864.7425|1|||||N|N
HE|HE|GHY|Hematocrit, Tube, Rack, Sealer, Holder|2||N|N||864.6400|4|||||N|N
HE|HE|GIA|Test, Leukocyte Peroxidase|1||N|N||864.7675|4|||||N|N
HE|HE|GIE|Fibrometer|2||N|N||864.5400|1|||||N|N
HE|HE|GIF|Diluent, Blood Cell|1||N|N||864.8200|4|||||N|N
HE|HE|GIG|Hemoglobinometer|2||N|P||864.7500|1|||||N|N
HE|HE|GII|Glutathione, Red-Cell|2||N|P||864.7375|7|||||N|N
HE|HE|GIL|Plasma, Fibrinogen Control|2||N|P||864.7340|1|||||N|N
HE|HE|GIO|Tube, Collection, Capillary Blood|1||N|N||864.6150|4|||||N|N
HE|HE|GIQ|Hemoglobin S|2||N|P||864.7415|1|||||N|N
HE|HE|GIR|Reagent, Russel Viper Venom|1||N|Y||864.8950|1|||||N|N
HE|HE|GIS|Test, Fibrinogen|2||N|P||864.7340|1|||||N|N
HE|HE|GIT|Reagent & Control, Partial Thromboplastin Time|2||N|N||864.7925|1|||||N|N
HE|HE|GIZ|Plasma, Control, Normal|2||N|N||864.5425|1|||||N|N
HE|HE|GJA|Test, Thrombin Time|2||N|N||864.7875|1|||||N|N
HE|HE|GJB|Thrombin|2||N|N||864.7875|1|||||N|N
HE|HE|GJC|Assay, Sulfhemoglobin|2||N|P||864.7490|1|||||N|N
HE|HE|GJG|Pipette, Quantitative, Hematology|1||N|N||864.6160|4|||||N|N
HE|HE|GJN|Fluid, Diluting, Red-Cell|1||N|N||864.8200|4|||||N|N
HE|HE|GJP|Control, Platelet|2||N|Y||864.8625|1|||||N|N
HE|HE|GJR|Control, Red-Cell|2||N|Y||864.8625|1|||||N|N
HE|HE|GJS|Test, Time, Prothrombin|2||N|N||864.7750|1|||||N|N
HE|HE|GJT|Plasma, Coagulation Factor Deficient|2||N|N||864.7290|1|||||N|N
HE|HE|GJW|Pipette, Pasteur|1||N|N||864.6160|4|||||N|N
HE|HE|GJZ|Cyanomethemoglobin Reagent And Standard Solution|2||N|Y||864.7500|1|||||N|N
HE|HE|GKA|Abnormal Hemoglobin Quantitation|2||N|P||864.7415|1|||||N|N
HE|HE|GKB|Device, Automated Sedimentation Rate|1||N|N||864.5800|4|||||N|N
HE|HE|GKE|Osmotic Fragility Testing|1||N|N||864.6600|4|||||N|N
HE|HE|GKF|Instrument, Hematocrit, Automated|2||N|P||864.5600|1|||||N|N
HE|HE|GKG|Centrifuge, Hematocrit|2||N|N||864.6400|4|||||N|N
HE|HE|GKH|Apparatus, Automated Blood Cell Diluting|1||N|N||864.5240|4|||||N|N
HE|HE|GKJ|Spinner, Slide, Automated|1||N|N||864.5850|4|||||N|N
HE|HE|GKK|Cyanomethemoglobin|2||N|P||864.7500|1|||||N|N
HE|HE|GKL|Counter, Cell, Automated (Particle Counter)|2||N|N||864.5200|1|||||N|N
HE|HE|GKM|Hand-Tally, Differential|1||N|N||864.6160|4|||||N|N
HE|HE|GKN|Timer, Clot, Automated|2||N|N||864.5400|1|||||N|N
HE|HE|GKP|Instrument, Coagulation, Automated|2||N|N||864.5400|1|||||N|N
HE|HE|GKQ|Test, Thromboplastin Generation|1||N|N||864.7900|4|||||N|N
HE|HE|GKR|System, Hemoglobin, Automated|2||N|P||864.5620|1|||||N|N
HE|HE|GKT|Separator, Automated, Blood Cell, Diagnostic|2||N|N||864.9245|1|||||N|N
HE|HE|GKW|Aggregometer, Platelet, Thrombokinetogram|2||N|N||864.6675|1|||||N|N
HE|HE|GKX|Instrument, Automated Platelet Counting|2||N|N||864.5200|1|||||N|N
HE|HE|GKZ|Counter, Differential Cell|2||N|N||864.5220|1|||||N|N
HE|HE|GLG|Platelet Counting, Manual|1||N|N||864.6160|4|||||N|N
HE|HE|GLK|Control, Hematocrit|2||N|Y||864.8625|1|||||N|N
HE|HE|GLQ|Mixture, Control, White-Cell And Red-Cell Indices|2||N|Y||864.8625|1|||||N|N
HE|HE|GLY|Oximeter To Measure Hemoglobin|2||N|P||864.7500|1|||||N|N
HE|HE|JBB|Solubility, Hemoglobin, Abnormal|2||N|P||864.7825|1|||||N|N
HE|HE|JBD|System, Analysis, Electrophoretic Hemoglobin|2||N|P||864.7440|1|||||N|N
HE|HE|JBE|Cell Enzymes (Erythrocytic And Leukocytic)|2||N|P||864.7100|1|||||N|N
HE|HE|JBF|Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening|2||N|P||864.7360|1|||||N|N
HE|HE|JBG|Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot|2||N|P||864.7360|1|||||N|N
HE|HE|JBH|Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Micromethod|2||N|P||864.7360|1|||||N|N
HE|HE|JBI|Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition|2||N|P||864.7360|1|||||N|N
HE|HE|JBJ|Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction|2||N|P||864.7360|1|||||N|N
HE|HE|JBK|Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic|2||N|P||864.7360|1|||||N|N
HE|HE|JBL|Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative|2||N|P||864.7360|1|||||N|N
HE|HE|JBM|Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Electrophoresis|2||N|P||864.7360|1|||||N|N
HE|HE|JBN|Fibrin Monomer Paracoagulation|2||N|Y||864.7300|7|||||N|N
HE|HE|JBO|Test, Euglobulin Lysis|2||N|P||864.7275|7|||||N|N
HE|HE|JBP|Activated Whole Blood Clotting Time|2||N|N||864.7140|1|||||N|N
HE|HE|JBQ|Antithrombin Iii Quantitation|2||N|N||864.7060|1|||||N|N
HE|HE|JBR|Test, Heparin Neutralization|2||N|N||864.7525|1|||||N|N
HE|HE|JBT|Timer, Coagulation|2||N|N||864.5400|1|||||N|N
HE|HE|JBW|Red-Cell Indices, Measured|2||N|P||864.5300|1|||||N|N
HE|HE|JBX|Aggregrometer, Platelet|2||N|N||864.6675|1|||||N|N
HE|HE|JBY|Aggregometer, Platelet, Photo-Optical Scanning|2||N|N||864.6675|1|||||N|N
HE|HE|JBZ|Study, Platelet Adhesive|2||N|N||864.6650|7|||||N|N
HE|HE|JCA|Device, Bleeding Time|2||N|N||864.6100|4|||||N|N
HE|HE|JCF|Lymphocyte Separation Medium|1||N|N||864.8500|4|||||N|N
HE|HE|JCG|Fluid, Diluting, Manual Cell|1||N|N||864.8200|4|||||N|N
HE|HE|JCJ|Alkaline Phosphatase|1||N|N||864.7660|4|||||N|N
HE|HE|JCM|Control, Hemoglobin, Abnormal|2||N|P||864.7415|1|||||N|N
HE|HE|JCN|Control, Cell Counter, Normal And Abnormal|2||N|Y||864.8625|1|||||N|N
HE|HE|JCO|Bothrops Atrox Reagent|2||N|P||864.8100|1|||||N|N
HE|HE|JIO|Blood, Occult, Colorimetric, In Urine|2||N|Y||864.6550|1|||||N|N
HE|HE|JIP|Blood, Occult, Enzymatic Method, In Urine|2||N|Y||864.6550|1|||||N|N
HE|HE|JLM|Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase|2||N|P||864.7360|1|||||N|N
HE|HE|JMB|Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase|2||N|P||864.7360|1|||||N|N
HE|HE|JMC|Nadp Reduction (U.V.), Glucose-6-Phosphate Dehydrogenase|2||N|P||864.7360|1|||||N|N
HE|HE|JMH|Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase|2||N|P||864.7375|7|||||N|N
HE|HE|JOX|Analyzer, Heparin, Automated|2||N|N||864.5680|1|||||N|N
HE|HE|JOY|Device, Automated Cell-Locating|2||N|P||864.5260|1|||||N|N
HE|HE|JOZ|System, Automated Platelet Aggregation|2||N|N||864.5700|1|||||N|N
HE|HE|JPA|System, Multipurpose For In Vitro Coagulation Studies|2||N|Y||864.5425|1|||||N|N
HE|HE|JPB|Hemoglobin M|2||N|P||864.7415|1|||||N|N
HE|HE|JPC|Hemoglobin F Quantitation|2||N|P||864.7455|1|||||N|N
HE|HE|JPD|Hemoglobin A2 Quantitation|2||N|P||864.7400|1|||||N|N
HE|HE|JPE|Antithrombin Iii, Two Stage Clotting Time Assay|2||N|N||864.7060|1|||||N|N
HE|HE|JPF|Prothrombin-Proconvertin And Thrombotest|2||N|N||864.7735|7|||||N|N
HE|HE|JPH|Test, Erythrocyte Sedimentation Rate|1||N|N||864.6700|4|||||N|N
HE|HE|JPI|Device, Hematocrit Measuring|2||N|N||864.6400|4|||||N|N
HE|HE|JPJ|Red-Cell Indices, Calculated|2||N|P||864.5300|1|||||N|N
HE|HE|JPK|Mixture, Hematology Quality Control|2||N|Y||864.8625|1|||||N|N
HE|HE|JWO|Device, Blood Volume Measuring|2||N|P||864.5950|1|||||N|N
HE|HE|JWR|Atp Release (Luminescence)|1||N|Y||864.7040|1|||||N|N
HE|HE|KFF|Assay, Heparin|2||N|N||864.7525|1|||||N|N
HE|HE|KHE|Reagent, Occult Blood|2||N|Y||864.6550|1|||||N|N
HE|HE|KHF|Adenine Nucleotide Quantitation|1||N|Y||864.7040|1|||||N|N
HE|HE|KHG|Whole Blood Hemoglobin Determination|2||N|P||864.7500|1|||||N|N
HE|HE|KQE|Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase|2||N|P||864.7360|1|||||N|N
HE|HE|KQF|Assay, Glutathione Reductase|2||N|P||864.7375|7|||||N|N
HE|HE|KQG|Instrument, Coagulation|2||N|N||864.5400|1|||||N|N
HE|HE|KQH|Red-Cell Indices|2||N|P||864.5300|1|||||N|N
HE|HE|KQI|Assay, Fetal Hemoglobin|2||N|P||864.7455|1|||||N|N
HE|HE|KQJ|System, Fibrinogen Determination|2||N|P||864.7340|1|||||N|N
HE|HE|KRX|Calibrator For Cell Indices|2||N|Y||864.8150|1|||||N|N
HE|HE|KRY|Calibrator For Platelet Counting|2||N|Y||864.8175|1|||||N|N
HE|HE|KRZ|Calibrator For Hemoglobin And Hematocrit Measurement|2||N|Y||864.8165|1|||||N|N
HE|HE|KSA|Calibrator For Red-Cell And White-Cell Counting|2||N|Y||864.8185|1|||||N|N
HE|HE|KSB|Set, Transfer (Blood/Plasma)|2||N|N||864.9875|1|||||N|N
HE|HE|KSD|Device, Heat-Sealing|1||N|N||864.9750|4|||||N|N
HE|HE|KSE|Refrigerator, Freezer, Blood Storage|2||N|N||864.9700|4|||||N|N
HE|HE|KSF|Kit, Quality Control For Blood Banking Reagents|2||N|N||864.9650|1|||||N|N
HE|HE|KSG|Media, Potentiating For In Vitro Diagnostic Use|2||N|N||864.9600|4|||||N|N
HE|HE|KSH|Chamber, Environmental For The Storage Of Platelet Concentrate|2||N|N||864.9575|4|||||N|N
HE|HE|KSI|Lectins And Protectins|2||N|N||864.9550|4|||||N|N
HE|HE|KSK|Solution, Stabilized Enzyme|2||N|N||864.9400|1|||||N|N
HE|HE|KSL|Solution, Copper Sulfate For Specific Gravity Determinations|1||N|N||864.9320|4|||||N|N
HE|HE|KSM|System, Test, Combs, Automated|2||N|N||864.9300|1|||||N|N
HE|HE|KSN|Centrifuge, Cell-Washing, Automated For Immuno-Hematology|2||N|N||864.9285|1|||||N|N
HE|HE|KSO|Centrifuge, Blood-Bank For In Vitro Diagnostic Use|1||N|N||864.9275|4|||||N|N
HE|HE|KSP|Apparatus, Cell-Freezing And Reagents|1||N|N||864.9225|4|||||N|N
HE|HE|KSQ|Device, Blood Mixing And Blood Weighing|1||N|N||864.9195|4|||||N|N
HE|HE|KSR|Container, Empty, For Collection & Processing Of Blood & Blood Components|2||N|N||864.9100|1|||||N|N
HE|HE|KSS|Supplies, Blood-Bank|1||N|N||864.9050|1|||||N|N
HE|HE|KST|System, Blood Collection, Vacuum-Assisted, Manual|1||N|N||864.9125|4|||||N|N
HE|HE|KSW|System, Processing For Frozen Blood|2||N|N||864.9145|1|||||N|N
HE|HE|KSX|Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use|2||N|N||864.9160|4|||||N|N
HE|HE|KSY|Boxes, View, Blood Grouping|1||N|N||864.9185|4|||||N|N
HE|HE|KSZ|System, Test, Automated Blood Grouping And Antibody|2||N|N||864.9175|1|||||N|N
HE|HE|KZL|Device, Warming. Blood And Plasma|2||N|N||864.9205|1|||||N|N
HE|HE|LCO|Platelet Factor 4 Radioimmunoassay|2||N|N||864.7695|1|||||N|N
HE|HE|LCP|Assay, Glycosylated Hemoglobin|2||N|Y||864.7470|1|||||N|N
HE|HE|LGL|Assay, Bart'S, Hemoglobin|2||N|P||864.7500|1|||||N|N
HE|HE|LGO|Test, Leukocyte Typing|1||N|N||864.7675|4|||||N|N
HE|HE|LGP|Assay, Alpha-2-Antiplasmin|2||N|N||864.5425|1|||||N|N
HE|HE|LIM|Test, Screening, For D Positive Fetal Rbc'S|2||N|P||864.7455|1|||||N|N
HE|HE|LIZ|Assay, T Lymphocyte Surface Marker|2||N|N||864.5220|1|||||N|N
HE|HE|LJD|Assay, B Lymphocyte Marker|2||N|N||864.5220|1|||||N|N
HE|HE|LJX|Test, Urine Leukocyte|1||N|N||864.7675|4|||||N|N
HE|HE|LKZ|Red-Cell Count By Photometry|2||N|P||864.7100|1|||||N|N
HE|HE|LLG|Kit, Igg, Platelet Associated|2||N|N||864.5425|1|||||N|N
HE|HE|MAM|Dna-Probe, B And T Lymphocyte|2||N|N||864.5220|1|||||N|N
HE|HE|MIF|Prothrombin Fragment 1.2|2||N|P||864.7320|1|||||N|N
HE|HE|MLL|Hemoglobin C (Abnormal Hemoglobin Variant)|2||N|P||864.7415|1|||||N|N
HE|HE|MMH|Software, Blood Bank, Stand Alone Products|2||N|N||864.9175|1|||||N|N
HE|HE|MYJ|Device,Mixing And Weighing,Semi-Automated|2||N|N||864.9195|1|Cber||||N|N
HE|HE|MYX|System, Blood Collection, Vacuum-Assisted, Automated|1||N|N||864.9125|1|||||N|N
HE|HE|MZG|Test,Residual,Wbc In Leukoreduced Blood|2||N|N||864.8625|1|Cber||||N|N
HE|HE|NID|Assay, Proliferation, In Vitro, T Lymphocyte|2||N|N||864.5220|1|A device measuring the constituents of dividing DNA or other pre-division cellular constituents to classify the ability of T lymphocytes (a type of normal white blood mononuclear cell) to divide or proliferate in response to specific or non-specific added stimulants. The T lymphocytes may be normal in number or abnormally low in number due to a natural or induced immunosuppressed state in the patient.||||N|N
HE|HE|NOZ|Assay, 1,5-Anhydroglucitol (15ag)|2||N|N||864.7470|1|The test provides quantitative measurement of 1,5-anhydroglucitol (15AG) in patient's blood. The test is for professional use, and is indicated for the monitoring of glycemic control in people with diabetes.||||N|N
HE|HE|NPQ|Test, Factor V Leiden Mutations, Genomic Dna Pcr|2||N|N||864.7280|1|In vitro diagnostic test to detect the Factor V Leiden mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.||||N|N
HE|HE|NPR|Test, Factor Ii G20210a Mutations, Genomic Dna Pcr|2||N|N||864.7280|1|In vitro diagnostic test to detect the Factor II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.||||N|N
HE|HE|NRF|Material, Quality Control, Semen Analysis|2||N|N||864.8625|1|A semen analysis quality control material is a device used to determine the accuracy and precision of manual, semiautomated, and automated determinations of semen analysis parameters such as pH, sperm concentration, total sperm number, motility, morphology, vitality, and white blood cells.||||N|N
HE|HE|NRS|Control Material, Blood Circulating Epithelial Cancer Cell|2||N|N||864.8625|1| The Epithelial Cell Control Kit contains two levels of fixed cells that are stained with a fluorescence marker and are used to verify sample processing and cell analysis of circulating tumor cells.  This device is used as an assay quality control to ensure that sample detection and identification systems are able to detect circulating epithelial tumor cells.||||N|N
HE|HE|NVG|Tissue Culture, Accessories, Dental|1||Y|N||864.2240|4|Intended to temporarilty nourish cells on an avulsed tooth||||N|N
HE|HE|OAO|Cord Blood Processing System And Storage Container|2||N|N||864.9900|1|A cord blood processing system and storage container is a device intended for use in the processing and the storage of cord blood. This device is used as a functionally closed processing system by cord blood establishments.  This device includes containers, other soft goods, and centrifugation systems for cord blood product concentration, and a final container for the cryopreservation and the storage of cord blood products.|x|x|blood storage|N|N
HE|HE|OBW|11-Dehydro Thromboxane B2 Kit, Urinary|2||N|N||864.5700|1|The test kit is an enzyme-linked immunoassay (elisa) to determine levels of 11-dehydro thromboxane b2 (11dhtxb2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion.  For professional use only.|n/a|An enzyme linked immunosorbent assay (ELISA) for the detection of 11dhTxB2.|n/a|N|N
HE|HE|ODV|Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System|2||N|N||864.7750|1|An in vitro diagnostic assay for use in genotyping vitamin k epoxide reductase complex subunit one (VKORC1) alleles to aid in the identification of patients at risk for altered warfarin sensitivity.|genotyping test system|Uses DNA genotyping technology to determine patient genotype at the Vitamin k epoxide reductase complex subunit one (VKORC1) gene locus.|clinical samples (blood, saliva, buccal swab samples)|N|N
HE|HE|OMM|Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr|2||N|N||864.7280|1|In vitro diagnostic for the detection and genotyping of a single point mutation of the human 5, 10-methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia.|genotyping test system|Uses DNA genotyping technology to determine patient genotype at the 5, 10-methylenetetrahydrofolate reductase gene locus.|clinical samples (blood, saliva, buccal swab samples)|N|N
HE|HE|OOF|Cryogenic Cord Blood Storage Container|2||N|N||864.9900|1|Intended as a final container for the cryopreservation and the storage of cord blood products.  A cryogenic cord blood storage container is a flexible ethylene vinyl acetate (eva) or similar polymer bag intended as a final container for cryopreservation and storage of cord blood products in the liquid or vapor phases of liquid nitrogen.|Consists of flexible ethylene vinyl acetate (EVA) or similar polymer bag.  May include sterile fluid path and access ports and is designed to withstand freezing in the liquid and vapor phases of liquid nitrogen.|Acts as a physical container for cord blood products, and is designed to withstand freezing in the liquid and vapor phases of liquid nitrogen|Cord blood is collected from neonatal umbilical cord and stored for later infusion, injection or transplantation|N|N
HE|HE|OOX|Automated Occult Blood Analyzer|2||N|N||864.6550|1|The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories.  The automated test is used for the determination of gastrointestinal bleeding.|The system consists of an analyzer, test reagents (antibody, calibrators and controls) and collection devices containing buffer.|The test reagent contains an immunoassay utilizing monoclonal and polyclonal antibodies for human hemoglobin.  A light beam measures the antibody reaction, i.e. the absorbance fo the reaction mixture measures the concentration of hemoglobin in the specimen.|fecal samples|N|N
HE|HE|OQX|Self-Contained Blood Grouping |2||N|N||864.9175|1|Intended for single use for individual blood group determination for educational and informational purposes|Plastic card with mixing channels and monoclonal antibodies|The device is self-contained and consists of reagents and reaction areas and requires no other accessories with the exception of those used to add the blood sample to the device|Plastic/paper card, plate, slide or microtubules with blood grouping antibodies|N|N
HE|HE|ORG|Platelet And Plasma Separator For Bone Graft Handling|2||N|N||864.9245|1|Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics.|May include centrifuge, filters, tubes, syringes and needles|Uses centrifugal and/or filtration methods to separate the whole blood into components, after which the platelet rich plasma is withdrawn.|Blood drawn from peripheral veins, PRP applied to bony defects|N|N
HE|HE|OSL|Control, Fecal Occult Blood|2||N|N||864.6550|1|Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices.|The control solutions are in the aqueous form.|The test is based on the detection of human hemoglobin.  The negative control solution contains only buffer.  The positive control solution contains human hemoglobin at a specified concentration.  The control solution is placed in the test device according to the manufacturer's instructions.  The negative control produces one distinct color band in the control area and the positive control produces two color bands in the control and the test area of the lateral flow strips of the test device.|Occult blood in human stool.|N|N
HE|HE|OYE|Flow Cytometric Reagents And Accessories.|2||N|N||864.5220|1|To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or  number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as  immunodeficiency and cancer.|May include flow cytometers, monoclonal antibodies, lysis reagents, processing reagents, automated processing devices or pipetting devices.|Particles in suspension may be treated with fluorescent conjugated antibodies or fluorogenic compounds followed by interrogation in a flow cytometer that enumerates and characterizes each particle based on its physical and fluorescent characteristics.|Peripheral whole blood specimens, lymphoid biopsies, and neoplastic tissues.|N|N
HE|HE|PBA|Ecarin Clotting Time|f||N|N||864.5400|6|The TAS ECT Test Card is to be used with the TAS Analyzer and is intended to determine the anticoagulant effect of hirudin during CBP in patients who have HIT. It is suited for professional use in decentralized areas of testing near the site of patient care as well as for use in the more traditional laboratory. Monitoring with the TAS ECT is indicated for persons who have been identified with and/or confirmed as a high risk for HIT, and require high dose anticoagulant with hirudin for a scheduled or emergency CPB procedure.|The system requires pooled normmal human plasma to dilute the citrate whole blood usingpolypropylene plastic tube. The system's performance is monitored by two levels of quality control plasma avialble from Cardiovascular Diagnostics, Inc.|The TAS ECT provides one stage test which measures the clotting time of a plasma diluted, citrate whole blood after combining it with the prothrombin activator, ecarin. It is composed of a thin plastic card in which a flat, shallow reaction chamber containing all reagents necessary for the ECT test. In the reaction chamber, it also contains paramagnetic iron peroxide particles (PIOP) which is impeded by a clot.  The signal produced by the relative movement of the PIOP is interpreted by the TAS Analyzer and reported in seconds. The greater amount of recombinant hirudin in the patient blood, the longer the clotting time is generated by the TAS system.|Patient's citrated whole blood|N|N
HE|HE|PBC|Manual Blood Grouping And Antibody Test Systems|2||N|N||864.9175|1|A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens.|Solid|Manual|IVD|N|N
HE|HE|PDX|Flow Cytometry Calibrator|2||N|N||864.5220|1|Flow cytometer calibrators are polystyrene or other particles whose defined characteristics (e.g. number, size, scatter or fluorescence intensity) is used to standardize instrumentation or to quantify other particles or analytes measured by flow cytometers.|Beads for performing absolute counts of cells in suspension by flow cytometry  Beads for standardizing flow cytometers  Beads that are used to calibrate fluorescence intensity to quantify ligand binding or fluorogenic assays performed by flow cytometry  Beads that are used to perform calibration in addition to quality control of flow cytometric assays.    SHOULD NOT INCLUDE beads that are only used for quality control|Bead associated fluorescence or scattered light is used to determine the number of other particles in solution ratio-metrically and to calibrate fluorescence intensity scales on a flow cytometer to standardize measures.|Peripheral blood|N|N
HE|HE|PFK|Quality Control For Molecular Immunohematology Tests|2||N|N||864.9650|1|The quality control for molecular immunohematology assay is used to demonstrate that the test can correctly detect genetic variations of human erythrocyte antigens.|DNA or synthetic plasmids|Molecular|N/A|N|N
HE|HE|PGF|Red Cell Thawer, Microwave|3||N|N||864.9205|2|For thawing red cells prior to transfusion.|may be of various shape; can be metal or platic or a combination of metal and plastic|electromagnetic|frozen red cells|N|N
HE|HE|PGG|Plasma Thawer|2||N|N||864.9205|1|For thawing frozen plasma prior to transfusion.|various shapes, may be composed of metal and plastic|Electromagnetic|Frozen plasma|N|N
HE|HE|PHJ|System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations|2||N|N||864.7280|1|A multiplex genotying test system intended for the qualitative detection and identification of specific thrombophilia related gene mutations from genomic DNA by genomic amplification and mass spectrometry.  It is intended as an aid in diagnosis of patients with suspected thrombophilia.|A qualitative multiplex amplification-based genotyping test system.  Should not include any devices other than mass spectrometry-based detection systems.|The assay uses multiplex polymerase chain reaction and allele specific single base primer extension reactions to amplify and detect specific mutations located in the Factor V and prothrombin genes.  Genotyped products are resolved according to mass by mass spectrometry.|Human peripheral whole blood or other clinical samples.|N|N
HE|HE|PKG|Bone Marrow Processing Device To Support Hematopoietic Reconstitution|2||N|N||864.9245|1|Processing of bone marrow harvested from human donors to support hematopoietic reconstitution in a recipient.|May include centrifuge, pumps, valves, computerized safety/control systems, sterile single-use disposable tubing, and bags|Relies on a centrifugal field and may include filtration methods for separation of harvested bone marrow into its cellular and non-cellular components.|Bone marrow aspirates obtained from the iliac crest of human donors, processed and infused into the recipient¿s circulatory system|N|N
HE|IM|LOQ|Device, General Purpose, Hematology|2||N|N||866.6010|1|||||N|N
HE|IM|MVS|Kit,Typing,Hla-Dqb|2||N|N||866.5660|1|||||N|N
HE|IM|OXP|Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment|2||N|N||866.6010|1|X/Y DNA probe kit is intended to detect alpha satellite sequences in the centromere of chromosome (Chr) X and satellite III DNA at Yq12 of Chr Y along with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating Chr X and Y via FISH in interphase nuclei and metaphase spreads obtained from bone marrow (BM) specimens in recipients of opposite-sex BM transplantation (BMT) for hematological disorders. It is not intended to be used as a stand alone assay for test reporting; in subjects with like-sex BMT; in diagnostic testing or screening for constitutional X and Y Chr aneuploidies.|Reagents for monitoring engraftment of sex mismatched bone marrow transplantation for hematological disorders|fluorescence in situ hybridization (FISH)|opposite-sex bone marrow transplantation for hematological disorders|N|N
HE|PA|MVU|Reagents,Specific,Analyte|1||N|N||864.4020|4|||||N|N
HE||KEX|Sorter, Cell|U|1|N|N|||1|||||N|N
HE||KSJ|System,Identification,Hepatitis B Antigen|3||N|N|||2|||||N|N
HE||MAN|Assay, Interleukin|3||N|N|||2|||||N|N
HE||MRF|Enzyme Linked Immunosorbent Assay, Thrombus Precursor Protein|U|1|N|N|||1|||||N|N
HE||MTH|Tray, Leukocyte Typing|N|4|N|N|||3|||||N|N
HE||MTI|Kit, Cell Screening, Fetal|N|4|N|N|||3|||||N|N
HE||MTK|Kit, Sample Collection, Hiv|3||N|N|||3|||||N|N
HE||MTL|Monitor,Test,Hiv-1|3||N|N|||3|||||N|N
HE||MTN|Test, Syphilis, Treponemal|N|4|N|N|||3|||||N|N
HE||MTO|Software, Management, Microplate Assay|N|4|N|N|||3|||||N|N
HE||MTP|Antibody To Htlv-1, Elisa|3||N|N|||3|||||N|Y
HE||MTQ|Software, Blood Virus Applications|N|4|N|N|||3|||||N|N
HE||MTR|Progenitor Cell Enumeration|2||N|N|||1|Cber||||N|N
HE||MTS|Vials,Challenge,Endotoxin|N|4|N|N|||3|||||N|N
HE||MVW|Kit,Western Blot,Hiv-1|N|4|N|N|||3|||||N|N
HE||MVX|Antibody,Monoclonal Blocking,Hiv-1|N|4|N|N|||3|||||N|N
HE||MVY|Monoclonal,Hiv-1|N|4|N|N|||3|||||N|N
HE||MVZ|System,Test,Home,Hiv-1|3||N|N|||2|||||N|N
HE||MWB|Kit,Test,Saliva,Hiv-1&2|N|4|N|N|||3|||||N|N
HE||MWO|Reagent,Blood Bank,Quality Control|N|4|N|N|||3|||||N|N
HE||MYK|Kit,Cord Blood Collection|N|6|N|N|||7|||||N|N
HE||MYP|Test,Platelet Antibody|2||N|N|||1|Cber||||N|N
HE||MYQ|Kit,Antibody,Elution|N|4|N|N|||3|||||N|N
HE||MYS|Device,Ahf,Automated Cryoprecipitation|N|4|N|N|||3|||||N|N
HE||MYW|Irradiation,Blood Indicators|N|4|N|N|||3|||||N|N
HE||MYY|Separator,Semi-Automated,Blood Component|1||N|N|||1|Cber||||N|N
HE||MZH|Test,Quantitative,For Hla,Non-Diagnostic|N|4|N|N|||3|||||N|N
HE||MZI|Test,Qualitative,For Hla,Non-Diagnostic|U|1|N|N|||1|CBER||||N|N
HE||MZJ|System,Concentration,Hematopoietic Stem Cell|3||N|N|||3|||||N|N
HE||MZK|System,Separation,Hematopoietic Stem Cell|3||N|N|||3|||||N|N
HE||MZM|Device,Preparation,Fibrin Sealant|N|4|N|N|||3|||||N|N
HE||NDV|Test, Ecarin Clotting Time (Ect)|f||N|N|||6|||||N|N
HE||NJN|Platelets, Photochemical Treatment System|3||N|N|||3|The photochemical treatment system is a class iii medical device for the preparation and storage of pathogen reduced donor derived platelets. The device has the process capability for the pathogen inactivation of platelets having platelet counts of 2.5-6.0x1011. The platelet products are indicated for support of patients requiring platelet transfusion according to clinical practice guidelines. There is no intended pharmacological effect attributed to residual amotosalen (s-59) in the platelet product.||||N|N
HE||OTQ|Research Use Only/Hematology Devices|N|6|Y|N|||7|For research use only and for products imported into the US only.|N/A|N/A|N/A|N|N
HE||OVG|Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)|f||N|N|||6|For processing hematopoietic progenitor cells-apheresis (HPC-A) from an HLA-identical donor to obtain a CD34 positive cell enriched population that will provide for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft-vs-host disease (GVHD) prophylaxis.|Anti-CD34 Antibody, Paramagnetic dextran beads, Tubing, Permanent Magnet, Software controlled pumps and valves, Buffers, Filters, Polymer Bags|To select CD34+ hematopoietic progenitor cells from apheresis (HPC-A) labeled with antibody conjugated to paramagnetic beads using a semiautomated magnetic column.|Hematopoietic Progenitor Cells-apheresis (HPC-A) separated from whole blood.|Y|Y
HE||OYT|Blood Establishment Computer Software, User Developed|U|1|N|N|||4|To store information that blood establishement personnel use to make decisions concerning the suitability of blood and blood products for further manufacture or transfusion.|solid|Software|blood establishment|N|N
HE||PDC|Investigational Use Only - Hematology|N|6|Y|N|||7|Investigational use only and for products imported into the US only.|N/A|N/A|N/A|N|N
HE||PEP|Molecular Erythrocyte Typing Test|3||N|N|||2|Molecular determination of allelic variants that indicate erythrocyte antigen phenotypes|Solid|Molecular|DNA|N|N
HE||PJF|Illuminator System For Blood Products|3||N|N|||2|Preparation and storage of pathogen-reduced, blood components.|solid|chemical treatment with UVA illumination|blood components|N|N
HO|AN|CAH|Filter, Bacterial, Breathing-Circuit|2||N|P||868.5260|1|||||N|N
HO|DE|NSB|Patient Personal Hygiene Kit|1||Y|N||872.6855|4|This device contains items given to an individual during their hospital stay.||||N|N
HO|GU|NIH|Disinfectant, Subsystem, Water Purification|2||N|N||876.5665|4|Disinfectant intended for reprocessing water purification systems for hemodialysis.||||N|N
HO|GU|NII|Disinfectant, Dialysate Delivery System|2||N|N||876.5860|1|Disinfectant intended for reprocessing dialysate delivery systems.||||N|N
HO|HO|BRT|Restraint, Patient, Conductive|1||N|Y|M|880.6760|4|||||N|N
HO|HO|BRZ|Set, Blood Transfusion|2||N|Y||880.5440|1|||||N|N
HO|HO|BWJ|Locator, Acupuncture Point|2||N|N||880.5580|1|||||N|N
HO|HO|BYY|Tube, Aspirating, Flexible, Connecting|2||N|N||880.6740|4|||||N|N
HO|HO|BYZ|Trap, Sterile Specimen|2||N|N||880.6740|4|||||N|N
HO|HO|CAK|Microfilter, Blood Transfusion|2||N|N||880.5440|1|||||N|N
HO|HO|CAR|Monitor, Spinal-Fluid Pressure, Electrically Powered|2||N|P||880.2460|1|||||N|N
HO|HO|CBC|Bottle, Collection And Trap, Breathing System (Uncalibrated)|2||N|N||880.6740|4|||||N|N
HO|HO|CBD|Bottle, Collection, Breathing System (Calibrated)|2||N|N||880.6740|4|||||N|N
HO|HO|DWL|Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)|2||N|P||880.5780|4|||||N|N
HO|HO|FLE|Sterilizer, Steam|2||N|Y|M|880.6880|1|||||N|N
HO|HO|FLF|Sterilizer, Ethylene-Oxide Gas|2||N|P||880.6860|1|||||N|N
HO|HO|FLG|Cleaner, Ultrasonic, Medical Instrument|1||N|N||880.6150|4|||||N|N
HO|HO|FLH|Washer Of Body Waste Receptacles|1||Y|N||880.6800|4|||||N|N
HO|HO|FLI|Cabinet, Ethylene-Oxide Gas Aerator|2||N|P||880.6100|1|||||N|N
HO|HO|FLK|Thermometer, Clinical Mercury|2||N|N||880.2920|4|||||N|N
HO|HO|FLL|Thermometer, Electronic, Clinical|2||N|Y|M|880.2910|1|||||N|N
HO|HO|FLN|Monitor, Electric For Gravity Flow Infusion Systems|2||N|P||880.2420|1|||||N|N
HO|HO|FMA|Depressor, Tongue, Non-Surgical|1||Y|N||880.6230|4|||||N|N
HO|HO|FMC|Patient Examination Glove|1||N|Y|M|880.6250|1|||||N|N
HO|HO|FME|Gown, Examination|1||Y|N||880.6265|4|||||N|N
HO|HO|FMF|Syringe, Piston|2||N|Y|M|880.5860|1|||||N|N
HO|HO|FMG|Stopcock, I.V. Set|2||N|Y||880.5440|1|||||N|N
HO|HO|FMI|Needle, Hypodermic, Single Lumen|2||N|Y|M|880.5570|1|||||N|N
HO|HO|FMJ|Manometer, Spinal-Fluid|2||N|P||880.2500|1|||||N|N
HO|HO|FML|Chair, Blood Donor|1||Y|N||880.6140|4|||||N|N
HO|HO|FMP|Protector, Skin Pressure|1||Y|N||880.6450|4|||||N|N
HO|HO|FMQ|Restraint, Protective|1||N|Y|M|880.6760|4|||||N|N
HO|HO|FMR|Device, Transfer, Patient, Manual|1||Y|N||880.6785|4|||||N|N
HO|HO|FMS|Bed, Pediatric Open Hospital|2||N|N||880.5140|4|||||N|N
HO|HO|FMT|Warmer, Infant Radiant|2||N|P||880.5130|1|||||N|N
HO|HO|FMW|Cover, Mattress (Medical Purposes)|1||Y|N||880.6190|4|||||N|N
HO|HO|FMZ|Incubator, Neonatal|2||N|Y|M|880.5400|1|||||N|N
HO|HO|FNG|Lift, Patient, Ac-Powered|2||N|N||880.5500|4|||||N|N
HO|HO|FNJ|Bed, Manual|1||Y|N||880.5120|4|||||N|N
HO|HO|FNK|Bed, Hydraulic, Adjustable Hospital|1||N|N||880.5110|4|||||N|N
HO|HO|FNL|Bed, Ac-Powered Adjustable Hospital|2||N|N||880.5100|4|||||N|N
HO|HO|FNM|Mattress, Air Flotation, Alternating Pressure|2||N|N||880.5550|4|||||N|N
HO|HO|FNN|Nipple, Lambs Feeding|1||Y|N||880.5640|4|||||N|N
HO|HO|FNP|Urinal|1||Y|N||880.6730|4|||||N|N
HO|HO|FNS|Ring Cutter|1||Y|N||880.6200|4|||||N|N
HO|HO|FNY|Basin, Emesis|1||Y|N||880.6730|4|||||N|N
HO|HO|FOA|Board, Cardiopulmonary|1||Y|N||880.6080|4|||||N|N
HO|HO|FOB|Bedpan|1||Y|N||880.6730|4|||||N|N
HO|HO|FOD|Device, Occlusion, Umbilical|1||N|N||880.5950|4|||||N|N
HO|HO|FOH|Mattress, Water, Temperature Regulated|1||N|N||880.5560|4|||||N|N
HO|HO|FOK|Pad, Neonatal Eye|1||Y|N||880.5270|4|||||N|N
HO|HO|FOS|Catheter, Umbilical Artery|2||N|Y||880.5200|1|||||N|N
HO|HO|FOX|Stand, Infusion|1||N|N||880.6990|4|||||N|N
HO|HO|FOZ|Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days|2||N|Y||880.5200|1|||||N|N
HO|HO|FPA|Set, Administration, Intravascular|2||N|Y||880.5440|1|||||N|N
HO|HO|FPB|Filter, Infusion Line|2||N|Y||880.5440|1|||||N|N
HO|HO|FPF|Bottle, Hot/Cold Water|1||Y|N||880.6085|4|||||N|N
HO|HO|FPK|Tubing, Fluid Delivery|2||N|Y||880.5440|1|||||N|N
HO|HO|FPL|Incubator, Neonatal Transport|2||N|Y|M|880.5410|1|||||N|N
HO|HO|FPO|Stretcher, Wheeled|2||N|N||880.6910|4|||||N|N
HO|HO|FPP|Stretcher, Hand-Carried|1||Y|N||880.6900|4|||||N|N
HO|HO|FPS|Board, Bed|1||Y|N||880.6070|4|||||N|N
HO|HO|FQA|Scale, Surgical Sponge|1||Y|N||880.2740|4|||||N|N
HO|HO|FQH|Lavage, Jet|2||N|N||880.5475|4|||||N|N
HO|HO|FQJ|Support, Scrotal, Therapeutic|1||Y|N||880.5820|4|||||N|N
HO|HO|FQK|Binder, Perineal|1||Y|N||880.5160|4|||||N|N
HO|HO|FQL|Stocking, Medical Support (For General Medical Purposes)|1||Y|N||880.5780|4|||||N|N
HO|HO|FQM|Bandage, Elastic|1||Y|N||880.5075|4|||||N|N
HO|HO|FQZ|Thermometer, Clinical Color Change|1||N|N||880.2900|4|||||N|N
HO|HO|FRA|Purifier, Air, Ultraviolet, Medical|2||N|P||880.6500|1|||||N|N
HO|HO|FRC|Indicator, Biological Sterilization Process|2||N|P||880.2800|1|||||N|N
HO|HO|FRF|Cleaner, Air, Medical Recirculating|2||N|P||880.5045|1|||||N|N
HO|HO|FRG|Wrap, Sterilization|2||N|P||880.6850|1|||||N|N
HO|HO|FRI|Scale, Stand-On, Patient|1||Y|N||880.2700|4|||||N|N
HO|HO|FRJ|Chair, Geriatric|1||Y|N||880.6140|4|||||N|N
HO|HO|FRK|Chair, Examination And Treatment|1||Y|N||880.6140|4|||||N|N
HO|HO|FRL|Fiber, Medical, Absorbent|1||Y|N||880.5300|4|||||N|N
HO|HO|FRN|Pump, Infusion|2||N|Y|M|880.5725|1|||||N|N
HO|HO|FRP|Holder, Infant Position|1||Y|Y|M|880.5680|1|||||N|N
HO|HO|FRR|Chamber, Reverse Isolation, Patient Care|2||N|P||880.5450|1|||||N|N
HO|HO|FRW|Scale, Patient|1||N|N||880.2720|4|||||N|N
HO|HO|FRZ|Device, Patient Transfer, Powered|2||N|N||880.6775|4|||||N|N
HO|HO|FSA|Lift, Patient, Non-Ac-Powered|1||N|N||880.5510|4|||||N|N
HO|HO|FSD|Binder, Abdominal|1||Y|N||880.5160|4|||||N|N
HO|HO|GAZ|Tubing, Noninvasive|2||N|N||880.6740|4|||||N|N
HO|HO|GCX|Apparatus, Suction, Operating-Room, Wall Vacuum Powered|2||N|N||880.6740|4|||||N|N
HO|HO|HEF|Binder, Breast|1||Y|N||880.5160|4|||||N|N
HO|HO|HFS|Shield, Nipple|1||N|N||880.5630|4|||||N|N
HO|HO|IKY|Mattress, Flotation Therapy, Non-Powered|1||Y|N||880.5150|4|||||N|N
HO|HO|JOJ|Indicator, Physical/Chemical Sterilization Process|2||N|P||880.2800|1|||||N|N
HO|HO|JOK|Scissors, Medical, Disposable|1||N|N||880.6820|4|||||N|N
HO|HO|JOL|Catheter And Tip, Suction|2||N|N||880.6740|4|||||N|N
HO|HO|KCT|Sterilization Wrap Containers, Trays, Cassettes & Other Accessories|2||N|P||880.6850|1|||||N|N
HO|HO|KDP|Regulator, Vacuum|2||N|N||880.6740|4|||||N|N
HO|HO|KDQ|Bottle, Collection, Vacuum|2||N|N||880.6740|4|||||N|N
HO|HO|KIA|Cover, Cast|1||Y|N||880.6185|4|||||N|N
HO|HO|KME|Bedding, Disposable, Medical|1||Y|N||880.6060|4|||||N|N
HO|HO|KMG|Purifier, Water, Ultraviolet, Medical|2||N|P||880.6710|4|||||N|N
HO|HO|KMH|Sterilizer, Dry Heat|2||N|P||880.6870|1|||||N|N
HO|HO|KMI|Monitor, Bed Patient|1||N|N||880.2400|4|||||N|N
HO|HO|KMJ|Lubricant, Patient|1||N|Y|M|880.6375|4|||||N|N
HO|HO|KMK|Device, Intravascular Catheter Securement|1||N|N||880.5210|4|||||N|N
HO|HO|KMN|Chair And Table, Medical|1||Y|N||880.6140|4|||||N|N
HO|HO|KMO|Binder, Elastic|1||Y|N||880.5160|4|||||N|N
HO|HO|KPD|Strip, Temperature, Forehead, Liquid Crystal|2||N|N||880.2200|4|||||N|N
HO|HO|KPE|Container, I.V.|2||N|P||880.5025|1|||||N|N
HO|HO|KXF|Applicator, Absorbent Tipped, Non-Sterile|1||Y|N||880.6025|4|||||N|N
HO|HO|KXG|Applicator, Absorbent Tipped, Sterile|1||Y|N||880.6025|4|||||N|N
HO|HO|KYP|Kit, Suction, Snake-Bite|1||N|N||880.5740|4|||||N|N
HO|HO|KYQ|Kit, Chemical Snake-Bite|3||N|N||880.5760|2|Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96||||N|N
HO|HO|KYR|Bag, Ice|1||Y|N||880.6050|4|||||N|N
HO|HO|KYS|Insoles, Medical|1||N|N||880.6280|4|||||N|N
HO|HO|KYT|Light, Examination, Medical, Battery Powered|1||Y|N||880.6350|4|||||N|N
HO|HO|KYW|Container, Liquid Medication, Graduated|1||Y|N||880.6430|4|||||N|N
HO|HO|KYX|Dispenser, Liquid Medication|1||Y|N||880.6430|4|||||N|N
HO|HO|KYZ|Syringe, Irrigating (Non Dental)|1||Y|N||880.6960|4|||||N|N
HO|HO|KZA|Device, Vein Location, Liquid Crystal|1||N|N||880.6970|4|||||N|N
HO|HO|KZD|Infusor, Pressure, For I.V. Bags|1||N|N||880.5420|4|||||N|N
HO|HO|KZE|Injector, Fluid, Non-Electrically Powered|2||N|P||880.5430|1|||||N|N
HO|HO|KZF|Device, Medical Examination, Ac Powered|1||N|N||880.6320|4|||||N|N
HO|HO|KZH|Introducer, Syringe Needle|2||N|P||880.6920|1|||||N|N
HO|HO|LBI|Unit, Neonatal Phototherapy|2||N|P||880.5700|1|||||N|N
HO|HO|LBJ|Device, Vein Stabilization|1||Y|N||880.6980|4|||||N|N
HO|HO|LDS|Device, Pasteurization, Hot Water|2||N|N||880.6991|4|||||N|N
HO|HO|LGM|Chamber, Patient Isolation|2||N|P||880.5450|1|||||N|N
HO|HO|LGN|Chamber, Patient Transport Isolation|2||N|P||880.5450|1|||||N|N
HO|HO|LHB|Timer, Apgar|1||Y|N||880.2930|4|||||N|N
HO|HO|LHI|Set, I.V. Fluid Transfer|2||N|Y||880.5440|1|||||N|N
HO|HO|LJL|Detectors And Removers, Lice, (Including Combs)|1||N|N||880.5960|4|||||N|N
HO|HO|LJS|Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days|2||N|N||880.5970|1|||||Y|N
HO|HO|LJT|Port & Catheter, Implanted, Subcutaneous, Intravascular|2||N|N||880.5965|1|||||Y|N
HO|HO|LLI|Bed, Therapeutic, Ac-Powered, Adjustable Home-Use|2||N|N||880.5100|4|||||N|N
HO|HO|LRJ|Disinfectant, Medical Devices|1||N|N||880.6890|4|||||N|N
HO|HO|LRT|Indicator, Sterilization|2||N|P||880.2800|1|||||N|N
HO|HO|LYY|Latex Patient Examination Glove|1||N|Y|M|880.6250|1|A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.||||N|N
HO|HO|LYZ|Vinyl Patient Examination Glove|1||N|Y|M|880.6250|1|A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand  for medical purposes to provide a barrier against potentially infectious materials and other contaminants.||||N|N
HO|HO|LZA|Polymer Patient Examination Glove|1||N|Y|M|880.6250|1|A  nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.||||N|N
HO|HO|LZB|Finger Cot|1||N|Y|M|880.6250|4|||||N|N
HO|HO|LZC|Patient Examination Glove, Specialty|1||N|Y|M|880.6250|1|A disposable latex examination glove is a device made of natural rubber latex or synthetic rubber that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminan.  In addition, these gloves have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using test such as astm d6978-05,  standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs.||||N|N
HO|HO|LZF|Pump, Infusion, Analytical Sampling|2||N|Y|M|880.5725|1|||||N|N
HO|HO|LZG|Pump, Infusion, Insulin|2||N|N||880.5725|1|||||N|N
HO|HO|LZH|Pump, Infusion, Enteral|2||N|Y|M|880.5725|1|||||N|N
HO|HO|MDR|Binder, Medical, Therapeutic|1||Y|N||880.5160|4|||||N|N
HO|HO|MEA|Pump, Infusion, Pca|2||N|Y|M|880.5725|1|||||N|N
HO|HO|MEB|Pump, Infusion, Elastomeric|2||N|Y|M|880.5725|1|||||N|N
HO|HO|MEC|Disinfector, Medical Devices|2||N|N||880.6992|4|||||N|N
HO|HO|MED|Sterilant, Medical Devices|2||N|Y||880.6885|1|||||N|N
HO|HO|MEG|Syringe, Antistick|2||N|N||880.5860|1|||||N|N
HO|HO|MHC|Port, Intraosseous, Implanted|2||N|N||880.5570|1|||||Y|N
HO|HO|MHD|Pump, Infusion, Gallstone Dissolution|2||N|Y|M|880.5725|1|||||N|N
HO|HO|MJF|Check Valve, Retrograde Flow (In-Line)|2||N|Y||880.5440|1|||||N|N
HO|HO|MKB|Device, Germicidal, Ultraviolet|2||N|P||880.6500|1|||||N|N
HO|HO|MLR|Sterilizer, Chemical|2||N|P||880.6860|1|||||N|N
HO|HO|MMK|Container, Sharps|2||N|Y|M|880.5570|1|||||N|N
HO|HO|MMS|Lubricant, Vaginal, Patient|1||N|Y|M|880.6375|1|||||N|N
HO|HO|MQX|Needle, Acupuncture, Single Use|2||N|P||880.5580|1|||||N|N
HO|HO|MRB|Indicator, Biological, Liquid Chemical Sterilization Process|2||N|P||880.2800|1|||||N|N
HO|HO|MRL|Scale, Sponge, Surgical, Electrically-Powered|1||N|N||880.2740|4|||||N|N
HO|HO|MRZ|Accessories, Pump, Infusion|2||N|Y|M|880.5725|1|||||N|N
HO|HO|MTC|Indicator,Chemical,Enzymatic,Sterilization Process|2||N|P||880.2800|1|||||N|N
HO|HO|MZR|Topical Approximation System|1||N|N||880.5240|4|||||N|N
HO|HO|NEP|System/Device, Pharmacy Compounding|2||N|N||880.5440|4|||||N|N
HO|HO|NGT|Saline, Vascular Access Flush|2||N|N||880.5200|1|Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.||||N|N
HO|HO|NKK|Needle, Hypodermic, Single Lumen, Reprocessed|2||N|N||880.5570|1|||||N|N
HO|HO|NKN|Syringe, Piston, Reprocessed|2||N|N||880.5860|1|A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger.  At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle.  The device is used to inject fluids into, or withdraw fluids from, the body.||||N|N
HO|HO|NRV|Implantable Radio Frequency Transponder System|2||N|N||880.6300|1|An implantable microtransponder system intended to facilitate access to identification and health information in humans.  It is described as consisting of a small implantable electronic microtransponder, an insertion device (introducer), and an electronic scanner (pocket reader). The microtransponder is a passive device that contains an electronic circuit, which is activated externally by a low-powered radio beam sent by a handheld, battery-powered pocket reader.  The microtransponder stores only a unique electronic identification number (id).  The id number is used to access a database that provides the implanted person's identity and health information supplied by the patient||||Y|N
HO|HO|NRW|Stimulator, Intramuscular, Automatic|2||N|N||880.5580|1|The Automatic Intramuscular Stimulator is a device that aids muscle stimulation by using a method called dry needling for treatment.  The device consists of a main control unit, a hand-held motor unit, and an AC power supply adapter.  The motor unit has a mounted disposal syringe and a needle mounting hardware for a disposable needle, and enables the practitioner to administer treatment with less physical effort.   An EMG needle is used instead of an acupuncture needle because it is less flexible than the acupuncture needle||||N|N
HO|HO|NSC|Injector, Pen|2||N|N||880.5860|1|A pen injector is a device that provides a nonelectrically-powered, mechanically-operated method of accurately injecting a dose of medicinal product from a medicinal cartridge, reservoir, or syringe through a manually-inserted single lumen hypodermic needle.  The device can be used by health professionals or for self-injection by the patient.||||N|N
HO|HO|NTC|Nursing Pad, Hydrogel|1||N|N||880.5630|4|||||N|N
HO|HO|NTX|Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)|1||N|N||880.5630|4|A NURSING PAD CONSISTING OF A POLYURETHANE PAD WITH GLYCERIN USED TO RELIEVE NIPPLES THAT ARE SORE AND CRACKED FROM BREASTFEEDING.||||N|N
HO|HO|NXH|Nursing Pad, Cohesive Gel|1||N|N||880.5630|4|Intended to relieve nipples that are sore and cracked from breast feeding.|device is composed primarily of a cohesive gel|independently|breast|N|N
HO|HO|NZD|Stretcher, Patient Restraint|1||Y|N||880.6900|4|Soft restraints to be attached to a backboard or stretcher in order to immobilize the patient in emgency situations.|fabric/nylon straps with velcro ends to be attached to the backboard|soft material restraint to be secured to the backboard/stretcher|torso and legs|N|N
HO|HO|NZG|Bassinet, Hospital|2||N|N||880.5140|4|Intended for medical purposes designed for the use of a pediatric patient made of stainless steel used in a hospital nursery.|bassinett|made of stainless steel|pediatric|N|N
HO|HO|NZH|Medication Management System, Remote|2||N|N||880.6315|1|A remote medication management system provides a means for the patient's prescribed medications to be stored in a delivery unit; For a medical provider to remotely schedule the patient's prescribed medications; To provide notification to the patient when the prescribed medications are due to be taken; To release the prescribed medications to a tray of the delivery unit accessible to the patient on the patient's command; And to provide to the medical provider a history of the event. The system is intended for use as an aid to medical providers in managing therapeutic regimens for patients in the home or clinic.|A remote medication management system consists of three primary components: control software (clinical and communications software), the medication delivery unit, and a specialized blister package containing the patient's prescribed medications that the patient receives from a pharmacy and stores in the medication delivery unit.|A clinician using the clinical software enters the patient's prescribed medication schedule.  The patient goes to a pharmacy and receives the prescription packaged in one or more blister pack discs.  The medication delivery unit then dispenses the medication at the quantities and schedule that were prescribed by the clinician.|Intended for delivery of pill type medication.|N|N
HO|HO|NZJ|Respirator, N95, For Use By The General Public In Public Health Medical Emergencies|2||N|N||880.6260|1|It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids.|N 95 NIOSH-certified respirator made of known filtration materials arranged in layers|NIOSH-certified N95 respirator made of known materials|Covers the nose and mouth of the wearer|N|N
HO|HO|NZW|Heparin, Vascular Access Flush|2||N|N||880.5200|1|Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.|Liquid solution|Physically occupies spacewithin the vascular catheter and exerts pressure on the patient's blood to prevent blood from backfilling into the catheter and clotting.|Vascular catheter|N|N
HO|HO|NZX|Water, Vascular Access Flush|2||N|N||880.5200|1|Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.|Liquid|Physically occupies space within the vascular catheter and exerts pressure on the patient's blood to prevent blood from backfilling into the catheter and clotting|vascular catheter|N|N
HO|HO|OBK|Port, Protector/Cushion|2||N|N||880.5965|1|Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports.|Device is a foam ring with adhesive that is placed on intact skin over the port access site. The foam ring can be any defined shape that covers the port. The foam provides a barrier to the implanted port.|Device is applied on top of intact skin and provides a protection barrier over the implanted port.|The device is used on intact skin.|N|N
HO|HO|OCI|Indicator, Physical/Chemical, Storage Temperature|2||N|N||880.2800|1|The time-temperature indicator provides a visual signal that a selected time-temperature profile has been exceeded.  When affixed to a device, a time temperature indicator is indicated, via a permanent color change, for the purpose of distinguishing between medical products that have exceeded a selected time-temperature profile of interest to the user from products that have not exceeded that profile.|Plastic label stock, with adhesive backing. Reference and active inks are deposited upon the plastic stock. The reference ring is printed with UV curable ink or a solvent-based ink, depending on the substrate. The active ink contains a suspension of diacetylenic monomers within a nitrocellulose-based ink vehicle.|The mode of operation is through the solid state polymerization of diacetylenes (DAs) to form poly(diacetylenes) (PDAs).|Affixed to packaging of a device.|N|N
HO|HO|ODI|Adminstration Set Docking Station|2||N|N||880.5440|1|Temporary closing IV administration set.  Temporary aseptic closure of the male Luer connector of the IV tubing in between uses for the life of the administration set.|Housing is made of polyethylene, piston is made of silicone|Temporary barrier against airborne contaminants|indirect contact, intravascular administration of fluids|N|N
HO|HO|ODY|Tunneled Catheter Remover|2||N|N||880.5970|1|To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be safely removed from the body.|The device is made of a rigid or semirigid material and is designed to be able to snap over the catheter body. The deivce may have a hinge or handle to assist in holding the device and manipulating the removal function during operation.|The device is designed to snap over a catheter body and to be guided over the cather through the insertion site and into the subcutaneous tissue where the catheter tissue cuff is adhering to the tissue. The user of the catheter removal device, with a gentle twisting and back and forth motion  of the device, will manually seperate the catheter cuff from the tissue and be able to fully remove the catheter from the body.|Tunneled Catheters with tissue ingrowth cuffs.|N|N
HO|HO|OHY|Pill Crusher/Cutter|1||N|N||880.6430|4|A device used to cut or crush medication to aid in consumption.  The device is intended to only be used with medications that are labeled as acceptable for crushing or cutting.|The device is aluminum/stainless steel with a handle, linkage arm, and anvil that are connected to pivot points by steel pins.|Cutting and/or crushing.|Pill|N|N
HO|HO|OIG|Powder-Free Guayle Rubber Examination Glove|1||N|N||880.6250|1|A disposable patient examination glove made from guayule natural rubber latex. This alternative source of natural rubber latex (guayale) does not contain the same protein associated with allergic reactions to latex products from the hevea rubber tree. This device is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.|A disposable patient examination glove made from guayule natural rubber latex. This alternative source of natural rubber latex (guayale) does not contain the same protein associated with allergic reactions to latex products from the hevea rubber tree. This device is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.|A disposable patient examination glove made from guayule natural rubber latex. This alternative source of natural rubber latex (guayale) does not contain the same protein associated with allergic reactions to latex products from the hevea rubber tree. This device is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.|The device is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.|N|N
HO|HO|OJA|Intravenous Extension Tubing Set|2||N|N||880.5440|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
HO|HO|OKC|Implanted Subcutaneous Securement Catheter|2||N|N||880.5970|1|Access to central venous system for blood sampling and infusion, and to provide a means to secure the catheter via a subcutaneous anchor below the insertion site.|Central venous catheter with subcutaneous securement system.|Central venous catheter with subcutaneous securement system.|vascular system, subcutaneous tissue.|Y|N
HO|HO|OKE|Port Introducer Kit|2||N|N||880.5965|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
HO|HO|OKL|Intravascular Administration Set, Automated Air Removal System|2||N|N||880.5445|1|An intravascular administration set, automated air removal system is a prescription device used to detect and automatically remove air from an intravascular administration set with minimal to no interruption in the flow of the IV fluid.|N/A|The device may include an air identification mechanism, software, an air removal mechanism, tubing, apparatus to collect removed air and safety control mechanisms to address hazardous situations. Once air is identified, the device air removal mechanism automatically removes the air from the intravascular administration set with minimal to no interruption in the flow of the IV fluid.|The device is intended for intravenous infusion systems.|N|N
HO|HO|OMF|Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position|2||N|N||880.5970|1|When used in connection with a locator instrument is designed to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure.|stainless steel stylet|device is placed inside a central venous catheter|blood vessels|Y|N
HO|HO|ONB|Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System|2||N|N||880.5440|1|Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.|Vial adator with piercing spikes, contain Luer-Lock connector fitted with elastomeric membrane to provide a sealed connection between syringe, I.V. administration set or tranfer bag. May contain side pressure-equalizing protector unit. May contain needle-free access port.|Placed over vial or container containing the chemotheraphy drug|Device is not act on any part of body. I.V. infusion devices, catheters, drug container closure system.|N|N
HO|HO|ONM|Radiant Infant Warmer Cabinet   |2||N|N||880.5130|1|The device is intended to provide an enclosure for storage of an radiant infant warmer. It may also provide a bassinet for use with the radiant infant warmer, and provide power to the infant radiant warmer.|The accessory could be in a range of sizs and materials. The important aspects are its capability of providing suppport as a bassinet and electrical safety.|When not in use, the device encloses the infant radiant warmer. The device opens to provide a bassinet placed under the warmer. The device includes a power outlet that provides power to the warmer and includes a cut-off switch to disconnect power when the accessory device is closed.|The accessory is intended for use with an infant radiant warmer, which are intended for use in warming the whole body of an infant.|N|N
HO|HO|OPB|Powdered Polychloroprene Patient Examination Glove|1||N|N||880.6250|1|A powdered polychloroprene patient examination glove is a disposable device made of polychloroprene rubber that bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.|A powdered polychloroprene patient examination glove is a disposable device made of polychloroprene rubber that bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.|A powdered polychloroprene patient examination glove is a disposable device made of polychloroprene rubber that bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.|glove|N|N
HO|HO|OPC|Powder-Free Polychloroprene Patient Examination Glove|1||N|N||880.6250|1|A powder free polychloroprene patient examination glove is a disposable device made of polychloroprene rubber tthat bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.|A powder free polychloroprene patient examination glove is a disposable device made of polychloroprene rubber tthat bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.|A powder free polychloroprene patient examination glove is a disposable device made of polychloroprene rubber tthat bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.|glove|N|N
HO|HO|OPD|Powdered Nitrile Patient Examination Glove|1||N|N||880.6250|1|A powdered nitrile (or polymer) patient examination glove  is a disposable device made of  nitrile rubber or synthetic polymers that bears powder to facilitate donning and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.|A powdered nitrile (or polymer) patient examination glove  is a disposable device made of  nitrile rubber or synthetic polymers that bears powder to facilitate donning and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.|A powdered nitrile (or polymer) patient examination glove  is a disposable device made of  nitrile rubber or synthetic polymers that bears powder to facilitate donning and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.|glove|N|N
HO|HO|OPE|Powdered Latex Patient Examination Glove|1||N|N||880.6250|1|A powdered latex patient examination glove is a disposable device made of natural rubber latex that bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.|A powdered latex patient examination glove is a disposable device made of natural rubber latex that bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.|A powdered latex patient examination glove is a disposable device made of natural rubber latex that bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.|A powdered latex patient examination glove is a disposable device made of natural rubber latex that bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.|N|N
HO|HO|OPF|Powdered Vinyl Patient Examination Glove|1||N|N||880.6250|1|A powdered vinyl patient examination glove is a disposable device made of poly(vinyl chloride)  that bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.|A powdered vinyl patient examination glove is a disposable device made of poly(vinyl chloride)  that bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.|A powdered vinyl patient examination glove is a disposable device made of poly(vinyl chloride)  that bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.|glove|N|N
HO|HO|OPH|Radiation Attenuating Medical Glove|1||N|N||880.6250|1|Radiations attenuating medical gloves are medical gloves that are used during medical or surgical procedures involving radiation to shield the hands of the wearer from scattered radiation exposure. The gloves offer some degree of protection to the hand from radiation exposure as well as protection from transmission of infectious agents.  The use of these gloves includes procedures that require the use of fluoroscopy or radiography.  In addition to meeting the requirements for examination or surgeon¿s gloves, manufacturers should have technical data to show that their attenuation claims meet the energy range of x-rays normally used in medical procedures.|Radiations attenuating medical gloves are medical gloves that are used during medical or surgical procedures involving radiation to shield the hands of the wearer from scattered radiation exposure. The gloves offer some degree of protection to the hand from radiation exposure as well as protection from transmission of infectious agents.  The use of these gloves includes procedures that require the use of fluoroscopy or radiography.  In addition to meeting the requirements for examination or surgeon¿s gloves, manufacturers should have technical data to show that their attenuation claims meet the energy range of x-rays normally used in medical procedures.|Radiations attenuating medical gloves are medical gloves that are used during medical or surgical procedures involving radiation to shield the hands of the wearer from scattered radiation exposure. The gloves offer some degree of protection to the hand from radiation exposure as well as protection from transmission of infectious agents.  The use of these gloves includes procedures that require the use of fluoroscopy or radiography.  In addition to meeting the requirements for examination or surgeon¿s gloves, manufacturers should have technical data to show that their attenuation claims meet the energy range of x-rays normally used in medical procedures.|Glove|N|N
HO|HO|OPI|Antimicrobial Medical Glove|1||N|N||880.6250|1|A disposable  medical glove (examination or surgeons)  that is worn on the examiner's hand to prevent contamination between patient and examiner and to serve the indicated use of the added antimicrobial agent which may vary with the added antimicrobial agent.|A disposable  medical glove (examination or surgeons)  that is worn on the examiner's hand to prevent contamination between patient and examiner and to serve the indicated use of the added antimicrobial agent which may vary with the added antimicrobial agent.|A disposable  medical glove (examination or surgeons)  that is worn on the examiner's hand to prevent contamination between patient and examiner and to serve the indicated use of the added antimicrobial agent which may vary with the added antimicrobial agent.|Glove|N|N
HO|HO|OPJ|Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs|1||N|N||880.6250|1|A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient and examiner.  In addition, these gloves have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using test such as astm d6978-05, standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs.|A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient and examiner.  In addition, these gloves have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using test such as ASTM D6978-05, Standard Practice for Assessment of Resistance of medical Gloves to Permeation by Chemotherapy Drugs.|A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient and examiner.  In addition, these gloves have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using test such as ASTM D6978-05, Standard Practice for Assessment of Resistance of medical Gloves to Permeation by Chemotherapy Drugs.|Glove|N|N
HO|HO|OPP|Pump, Infusion, Insulin Bolus|2||N|N||880.5725|1|The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.|The device is worn directly on the body. It is constructed of a variety of polymeric materials. Stainless steel is used in springs.|The device contains the insulin in a reservoir attached to a pumping mechanism. The pump delivers a discrete bolus volume to the patient on demand. There are no means of providing continuous infusion.|Subcutaneous tissue. The device is generally targeted for use on the abdomen, buttocks, or other location acceptable for insulin delivery and device placement.|N|N
HO|HO|ORW|N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies|2||N|N||880.6260|1|A single use, disposable, NIOSH-approved N95 respirator intended for use by the general public in public health medical emergencies to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions.|Solid.|Filtration. Antimicrobial / antiviral agent effectiveness.|It is a respirator.|N|N
HO|HO|OSI|Bariatric Bed|2||N|N||880.5100|4|A bed intended for obese patients weighing 500 pounds and above.  Beds can expand from 38 to 60 inches in width.|Bed|Bed|Bed|N|N
HO|HO|OSZ|Antimicrobial Keyboard|2||N|N||880.6600|1|To reduce microbial populations|device resides on a motorized drawer that is contained in an enclosure, the drawer slides outside of the enclosure for use then retracts into the light-tight enclusure for UV disinfection after use|self disinfecting computer keyboard and touchpad that utilized germicidal ultraviolet light in an enclosure|hands|N|N
HO|HO|OUG|Medical Device Data System|1||N|N||880.6310|4|A medical device data system (mdds) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices:  (i) the electronic transfer of medical device data;  (ii) the electronic storage of medical device data;  (iii) the electronic conversion of medical device data from one format to another format in accordance with a preset specification; Or  (iv) the electronic display of medical device data.  (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol.  This identification does not include devices intended to be used in connection with active patient monitoring.|Software and Electronics|Software algorithms to perform necessary medical communication functions|Hospital Information Systems|N|N
HO|HO|OUW|Infant Positioner, Rx, Use In Highly Monitored Setting|1||N|N||880.5680|1|Designed to position the baby at a 30 degree angle in the prone (on his/her stomach) position for specific medical or surgical conditions.  For use only when in a highly monitored setting with continuous cardio-respiratory and oxygen saturation monitoring.|DEVICE MAY BE WEDGE SHAPED TO MAINTAIN THE INFANT AT A 30 DEGREE ANGLE. MAY ALSO HAVE A COMPONENT THAT IS USED TO HELP MAINTAIN THE INFANT ON THE POSITIONER SUCH AS A BINDER.|MAINTAINS INFANT IN A DESIRED POSITION.|WHOLE BODY.|N|N
HO|HO|OVY|Liquid Chemical Processing System|2||N|N||880.6887|1|The liquid chemical processing system is intended as a standard method for routine monitoring.|The liquid chemical processing monitor consists of a filter paper-based carrier (¼ in x 1&#8540;  in) inoculated with G. stearothermophilus 7953 spores and packaged in a glassine envelope, a vial containing 5 ml of modified Trypticase Soy Broth with the pH indicator, phenol red media and closed with a screw cap, and a transfer clip.|The device is placed in the system with the load.  During the processing cycle, the liquid chemical processing monitor is exposed to the liquid chemical.  Some of the spores on the strip will be killed and and some of the spores will be physically washed off the strip.|This device is has no patient contact.|N|N
HO|HO|OWL|Peripheral Catheter Insertion Kit|2||N|N||880.5200|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
HO|HO|OWP|Biological Sterilization Process Indicator With Recombinant-Dna Plasmid|2||N|N||880.2805|1|A Recombinant-DNA plasmid biological indicator is intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization.|Bacterial spores containing recombinant-DNA plasmids are provided in an ampoule with a separate, contained compartment of appropriate growth media. The ampoule design should segregate the spores from the growth media until incubation and facilitate contained mixing, when required, of the spores and growth media without exposing any spores to the external environment.|The device consists of known number of genetically-modified bacterial spores, with known resistance to the intended sterilization process, containing deliberately introduced recombinant-DNA plasmids. The plasmids provide a new indicator signal mechanism to determine the presence of viable bacteria in the indicator signaling a failure in the sterilization process. Plasmid safety is evaluated by an Environmental Assessment in addition to performance testing.|The device is intended to be included with sterilization loads, within sterilization wraps, containers, pouches, trays and cassettes during sterilization cycles for which the use of this device has been validated.|N|N
HO|HO|OYS|Patient Bed With Canopy/Restraints|1||N|N||880.6760|4|Enclosed bed canopy system used as passive restraint.|It may consist of the following components:  (a) Metal/aluminum  rectangular frame  (b) Polyurethane or like material for tubular foam padding for the aluminum frame  (c) Four side panels composed of polyurethane-coated nylon pack cloth, gray polyester mesh  (or similar materials) and polyester coiled zippers with an enclosed canopy.|It is a passive bed enclosure that provides a solid framework and a soft canopy structure, which securely attaches to the bed and shelters and restrains the patient without touching the patient.  The canopy provides access to the patient through secured openings, allowing the healthcare worker the ability to provide routine care to the patient, while providing a more controlled environment when the patient is unattended.|entire body|N|N
HO|HO|OZK|Thermometer, Exhaled Breath|2||N|N||880.2910|1|To measure the temperature of exhaled human breath, which is frequently increased in airway inflammation in asthma patients. Measurement of changes in exhaled human breath temperature aids in evaluating airway inflammation treatment in asthma patients as an adjunct to established clinical and laboratory assessments of asthma.|The major components of the device are:  a.	A 0.5-litre silver plated flask in a metal cylinder (thermos)  b.	An air tube and thermal block made out of copper with an in-built temperature sensor. The thermal block has a tube-like part with high thermal capacity and excellent heat conduction properties  c.	Mouthpiece (Polypropylene)  d.	Inlet Cap (Polycarbonate)  e.	USB Port (Polyurethane)  f.	Environmental Chamber (Mild Sheet Metal)  g.	LCD Screen  h.	Navigation/Power/OK buttons (ABS)|The essence of the device technology is an environmental chamber with a thermal core heated by exhaled air from the patient. Each exhalation increases the temperature inside the reservoir until equilibrium is reached and measured by a thermal sensor. To use the device, the patient inhales through the nose and exhales into the device via a mouthpiece.  The temperature in the device is assessed by measuring the resistance of the thermal sensor by means of a digital ohm-meter.|Mouth|N|N
HO|HO|PAD|Chest Drainage Kit|2||Y|Y||880.6740|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
HO|HO|PDH|Blanket, Neonatal Phototherapy|2||N|N||880.5700|1|Is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting.|Comprised of a light-weight, spun bond polypropylene material. Spun bond polypropylene is a commonly used fabric in medical products and garments. The material is non-irritating to the skin, soft, and allows it to easily conform to body contours. The material is available in different fabric weights, depending on the tightness of the weave and fabric density. The spun bond polypropylene fabric has a generally open-weave structure to ensure maximum light transmittance through the fabric.|Comprised of a light-weight, spun bond polypropylene material. The blanket is intended to allow an infant undergoing phototherapy for hyperbilirubinemia to be tightly swaddled and still receive the full benefit of the phototherapy treatment. The design of the blanket allows the infant to be swaddled in a fashion such that only a single layer of fabric is ever interposed between the infant and the phototherapy light source.|Whole body.|N|N
HO|HO|PEC|Sterilizer Automated Loading System|2||N|N||880.6880|1|Provides automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The system consists of a user interface, loading conveyor, load transport shuttles, unloading conveyor to be used as an accessory to a sterilizer.|The system consists of a single point user interface station, loading conveyor, load transport shuttles, unloading conveyor and a sterilizer that sits on a loading car.|Works in conjunction with a steam sterilizer|NA|N|N
HO|HO|PEF|Heparin Flush In 0.45% Sodium Chloride|2||N|N||880.5200|1|The heparin flush in 0.45% sodium chloride is intended to maintain patency of an indwelling intravenous catheter device designed for intermittent injection or infusion therapy or blood sampling.  It provides an alternative to clinicians to prevent sodium overload in neonatal patients.|Transparent container, volume markings on the syringe barrel, tip cap, plunger stopper and Heparin Lock Flush solution|Attaach syringe to access device and flush.|Heparin lock device or central venous catheter.|N|N
HO|HO|PEQ|Accessories To Examination Light|1||N|N||880.6320|1|Accessories that attach to the light and assist in magnifying, clarifying, enhancing the image being viewed.|Lens, scopes|Uses Lens to improve the image of the surface area being viewed under the light.|skin|N|N
HO|HO|PEZ|Central Venous Catheter Dressing Change Kit|2||N|N||880.5200|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
HO|HO|PHC|Infusion Safety Management Software|2||N|N||880.5725|1|Infusion safety management software is a prescription device intended for use with infusion pumps and may include one or more of the following capabilities: prepopulation of infusion programming parameters, data retrieval and analysis for tracking and trending, drug infusion error reduction algorithms, and alarm transmission.|The device is a software application(s), which may be implemented as part of an infusion pump and may also be implemented onto a hospital information system for use with an infusion pump system.|Infusion safety management software may include one or more software applications that enforce safety control mechanisms through wireless or wired communication between the hospital information system, the infusion pump, and the healthcare provider.|Target area is according to the approved drug or biologic product labeling.|N|N
HO|HO|PJJ|Two Or More Sterilant Sterilizer|2||N|N||880.6860|1|Intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.|sterilizer|The sterilizer is a dual sterilant sterilizer using hydrogen peroxide and ozone as the sterilant|NA|N|N
HO|HO|PJO|Fall Prevention Alarm/Sensor Combination Attached Or Unattached|1||N|N||880.2400|4|The fall-prevention alarm/sensor is a combination device that can attach to a person usually by a clip or belt OR it can be used unattached to the person, where the person sits upon it.|This fall prevention alarm  can be used two way. It can  attach to a person's body or clothing or it can be used unattached where the person sits upon the sensor pad as with devices cleared under product code KMI.|The alarm activates when weight is applied to the sensor changes or the magnet clip disconnects from the alarm. This alarm may be connected to the Nurse Call System. If the alarm is connected to the hospital's Nurse Call System, the  nurse call station signal activates.  This device may also use an AC-power adaptor to power the alarm instead of batteries.  The adaptor does not charge the batteries.|Device  can be used two different ways: 1) attached to the person or 2) not attached to the person.   If used attached to the person, it can be applied to a person's clothing by use of the clip or it is worn around a person's waist via the belt.  It is not to be used on the head or neck areas.  If the belt is used, only the belt is applied around the person's waist. The belt is not looped around or through any chair, bed or furnituOrre so it does not act as a restraint.    If the device not not attached, the patient sits or lies upon the sensor pad.|N|N
HO|HO|PJP|Fall Prevention Alarm/Sensor Attached Only|1||N|N||880.2400|4|This  fall-prevention alarm/sensor works only when it is attached to a person.  It attaches to a person  usually by a clip or belt .|This fall prevention alarm  attaches to a person's body or clothing. A nurse call interface provides dual staff notification or enables the in-room alarm to be silenced.|The alarm activates when the clip (alarm cord) disconnects from the alarm. This alarm may be connected to the Nurse Call System. If the alarm is connected to the hospital's Nurse Call System, the  nurse call station signal activates.  This device may also use an AC-power adaptor to power the alarm instead of batteries.  The adaptor does not charge the batteries.|The device can be used only when it is attached to the person.   If attached to the person, it is attached to a person's clothing by use of the clip or it is worn around a person's waist with the supplied belt.  It is not to be used on the head or neck areas.  If the belt is used, the belt is applied around the person's waist. The belt is not looped around or through any chair, bed or furniture, so it does not act as a restraint.|N|N
HO|HO|PKP|Hizentra Infusion System|2||N|N||880.5725|1|A Hizentra Infusion System is a prescription device intended for subcutaneous delivery of Hizentra (Immune Globulin Subcutaneous (Human), 20% Liquid) in accordance with the FDA approved Hizentra labeling.|A Hizentra Infusion System includes the delivery device, reservoir or syringe, and any administration sets and / or subcutaneous catheters or needles to infuse Hizentra into subcutaneous tissue.|A Hizentra Infusion System infuses Hizentra into subcutaneous tissue in accordance with FDA approved Hizentra labeling.|In accordance with FDA approved labeling, Hizentra is for subcutaneous infusion only.|N|N
HO|PA|FMH|Container, Specimen, Sterile|1||N|N||864.3250|4|||||N|N
HO|PA|NNI|Container, Specimen, Non-Sterile|1||Y|N||864.3250|4|||||N|N
HO|PM|NXQ|Reminder, Medication|1||Y|N||890.5050|4|A medication reminder is a device intended for medical purposes to provide alerts to patients or healthcare providers for pre-determined medication dosing schedules.  The device may incorporate wireless communication.|The device size can range from a handheld device to that of a desk or countertop device.|The device is electrically-powered, either battery or AC, and may incorporate wireless technology.|Target area depends on intended target area of the drug or drugs taken by the patient.|N|N
HO|PM|OIZ|Foot Examination Tool For Inflammatory Changes|1||N|N||890.5050|4|Assist a patient to visualize the image and condition of the soles of their feet in connection with a daily self-examination for signs of inflammation on the sole of the foot.  The device will assist the patient in determining when they should contact their  healthcare provider for further diagnosis and treatment regarding any skin  changes seen by a mirror and/or highlighted by the liquid crystal foot pads.  Intended to be used as an adjunct to, and not in replacement of,  periodic foot care and examinations conducted by a health care professional and  used under the direction of a health care professional and does not diagnose any specific disease state.|n/a|A device that consists of a 2X convex mirror, surrounded on two sides by liquid  crystal pads. These liquid crystal pads react to skin temperature when the patient places his  feet on top of them, providing different colors for different temperatures. The device is a daily activity assist device. It provides visible and  thermal graphic images of the plantar surface of the foot. It is intended to assist the patient in  checking their feet for signs of inflammation as evidence by differences in the thermal patterns of  the plantar surface.|feet|N|N
HO|RA|OUJ|High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers|2||N|N||892.1570|1|To provide high level disinfection of ultrasound transducers.|ultrasonic transducer reprocessor, high level disinfectant, and accessories|Automatically generates a mist from a dedicated hydrogen peroxide disinfectant solution and exposes a suspended ultrasound transducer to the disinfectant ultrasound at a specified temperature and for a specified time to achieve high level disinfection|ultrasonic transducers|N|N
HO|SU|LGX|Table, Examination, Medical, Powered|1||N|N||878.4960|4|||||N|N
HO|SU|MMP|Cover, Barrier, Protective|2||N|P||878.4370|1|||||N|N
HO|SU|MSH|Respirator,Surgical|2||N|Y||878.4040|1|||||N|N
HO|SU|NZP|Sealant, Microbial |2||N|N||878.4370|1|Intended to isolate the site of a surgical incision from microbial contamination and indicated to reduce the risk of skin flora contamination of the surgical incision throughout a surgical procedure.|Applied as a liquid film which dries to a polymerized, flexible film on the treated skin|Cyanoacrylate liquid film applied to the intended incision site dries to a flexible barrier film which immobilizes skin flora in the treated area|Skin surrounding a planned surgical incision|N|N
HO|SU|OEA|Non-Surgical Isolation Gown|1||N|N||878.4040|4|A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material|An isolation gown is made of fabric material, either non-woven or woven|Serves as physical barrier to the transfer of microorganisms, body fluids and particulate material. Level of barrier protection is nonspecific.|An isolation gown covers the torso and clothing and poses a physical barrier to the transfer of microorganisms, body fluids and particulate material|N|N
HO|SU|OKF|Body Fluid Disposal Kit|2||N|N||878.4040|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
HO|SU|OKG|Body Fluid Clean Up Kit|2||N|N||878.4040|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
HO|SU|OKH|Body Fluid Barrier Kit|2||N|N||878.4040|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
HO|SU|OKI|Emergency Response Safety Kit|2||N|N||878.4040|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
HO|SU|ONT|N95 Respirator With Antimicrobial/Antiviral Agent|2||N|N||878.4040|1|A single use, disposable, NIOSH-approved respirator intended for occupational use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions.|The device is an N95 respirator composed of at least 3 layers of filtration material with bands or ties to secure it to the head, a flexible noseband to insure a close fit and an added, specified antimicrobial and/or antiviral agent added to the respirator.|Device uses a combination of tight facial fit and filtration to help reduce exposure to particulate aerosols plus the addition of an antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions|The device is worn over the nose and mouth  and is intended to protect the respiratory tract from hazardous particulates|N|N
HO|SU|ORC|Air Filter Portable Apparatus|2||N|N||878.5070|1|The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures.|A reusable mobile HEPA air filtration unit with a hose connecting to a disposable air delivery unit to be place at the surgical site.|The system uses an air supply hose connected to nozzle design that is to be mounted, or applied to the incision drape in close proximity to the surgical site to provide direct air flow blowing over the surgical incision site that helps reduce the level of ambient airborne contamination.|Surgical site.|N|N
HO|SU|OUK|Surgical Mask With Antimicrobial/Antiviral Agent|2||N|N||878.4040|1|A single use, disposable surgical mask for occupational use to cover the nose and mouth of the wearer to protect from the transfer of microorganisms,body fluids and particulates and has an added antimicrobial and/or antiviral agent which kills specific pathogens under specified contact conditions.|The device is a surgical mask composed of at least 3 layers of filtration material with bands or ties to secure it to the head, a flexible noseband and an added, specified antimicrobial and/or antiviral agent added to the surgical mask|Device uses a combination multiple filtration layers to protect from the transfer of microorganisms, body fluids and particulates plus the addition of an antimicrobial and/or antiviral agent which kills specified pathogensunder  specified contact conditions|The device is worn over the nose and mouth and is intended to protect the respiratory tract from transfer of microorganisms, body fluids and particulates.|N|N
HO|SU|OVR|Kit, First Aid, Talking|1||N|N||878.4014|4|The device provides verbal instructions pertaining to various first aid and common medical emergencies. The device does not contain any drug or supporting device that could be applied to the patient.|The device looks and functions like a programmable digital audio player, playing digital audio clips as individual digital audio files containing prerecorded, spoken First Aid information in a prescribed order (and language) as user pushes specific buttons. It is nothing more than an audio player, playing First Aid information as content.|The device works as an audio player playing various first aid instructions when buttons labeled with those first aid emergencies such as choking, burn are pressed.|The instructions are verbally relayed to the user for emergencies pertaining to CPR, Unconscious, Choking, Breathing, Allergic Reaction, Bleeding, Burns, Falls, Bone Injury, Poison, Bites, Stings, Seizures.|N|N
HO|SU|OXZ|Pediatric/Child Facemask|2||N|N||878.4040|1|A pediatric/child facemask is intended to be worn by the patient/child to provide protection for the respiratory tract.   It is a single use, disposable device that is provided non-sterile.   The facemask is recommended for use in a healthcare setting with appropriate adult supervision.|A pediatric/child facemask is constructed of nonwoven materials. A nosepiece is placed within the bindings for comfort and individualized fit. It is appropriately sized to the smaller faces of children across a diverse population.  It is intended to be worn by the patient/child and is a single use, disposable device. It is intended to be worn by the pediatric patient to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms and particulate materials.|Anthrophometric data requirement|Respiratory Tract|N|N
HO|SU|PIR|Mercy Tape 2d And 3d Models|1||N|N||878.4800|1|The Mercy TAPE device (2D and 3D models) is intended for use by health care professionals to estimate the body weight of pediatric patients between the ages of 2 months and 16 years, using linear measurements from specific anatomical landmarks made with the TAPE device for humeral length (HL, for the 2D model) or half-humeral length (HHL, for the 3D model) and the mid-upper arm circumference (MUAC).|The Mercy TAPE device consists of semi-durable or disposable flexible strips of coated paper, fabric or plastic tape printed with numbered bins proportional to fractional body weight of pediatric patients.|The 2D and 3D Mercy TAPE device combines the physical properties of the simple tape measure, with the intended use of the Stand-on patient scale and patient scale, which is estimation of body weight. TAPE performs this function based on an algorithm that is unique to the Mercy TAPE device. TAPE uses linear anthropometric body measurements to derive estimated body weight.|for humeral length (HL, for the 2D model) or half-humeral length (HHL, for the 3D model) and the mid-upper arm circumference (MUAC).|N|N
HO|SU|PLY|Antimicrobial Drapes|2||N|N||878.4370|1|Used to reduce the risk of skin flora contamination of the surgical wound during a surgical procedure.|Device is composed of transparent, breathable fluid barrier film laminated to acrylic pressure-sensitive adhesive that contains 2% CHG.  Drape is on a silicone-coated release liner.|Transparent, breathable fluid barrier film laminated to acrylic adhesive that contains 2% w/w Chlorhexidine Gluconate (CHG).  Adhesive drape is on a silicone-coated release liner.|skin/surgical wound|N|N
HO||LDH|System, Delivery, Allergen And Vaccine|U|1|N|N|||1|||||N|N
HO||LDI|Blanket, Fire|U|1|N|N|||1|||||N|N
HO||LDR|Controller, Infusion, Intravascular, Electronic|U|1|N|N|||1|||||N|N
HO||LEY|Set, Oral Administration|U|1|N|N|||1|||||N|N
HO||LGZ|Warmer, Thermal, Infusion Fluid|U|1|N|N|||1|||||N|N
HO||LHC|Warmer, Irrigation Solution|U|1|N|N|||1|||||N|N
HO||LHE|Controller, Closed-Loop Blood Glucose|3||N|N|||2|||||N|N
HO||LHF|Warmer, Microwave, Infusion Fluid|U|1|N|N|||1|||||N|N
HO||LJJ|Electrode, In Vivo Calcium Ion Selective|U|1|N|N|||1|||||N|N
HO||LKB|Pad, Alcohol, Device Disinfectant|N|6|N|N|||4|||||N|N
HO||LKG|Port & Catheter, Implanted, Subcutaneous, Intraventricular|U|1|N|N|||1|||||Y|N
HO||LKK|Pump, Infusion, Implanted, Programmable|3||N|N|||2|||||Y|N
HO||LLC|Container, Supplementary Nitroglycerin|U|1|N|N|||1|||||N|N
HO||LLD|Port & Catheter, Implanted, Subcutaneous, Intraperitoneal|U|1|N|N|||1|||||Y|N
HO||LMQ|Device, Peritoneal Access, Subcutaneous, Implanted|3||N|N|||3|||||Y|N
HO||LMX|Meter, Jaundice|3||N|N|||2|||||N|N
HO||LMY|Monitor, Skin Resistance/Skin Temperature,  For Insulin Reactions|3||N|N|||2|||||N|N
HO||LNX|Medical Computers And Software|U|1|N|N|||1|||||N|N
HO||LNY|Catheter, Percutaneous, Long Term, Intraspinal|3||N|N|||2|||||N|N
HO||LPZ|Container, Frozen Donor Tissue Storage|U|1|N|N|||1|||||N|N
HO||LSX|Controller, Closed-Loop, Blood-Pressure|3||N|N|||2|||||N|N
HO||LWE|Bone Marrow Collection/Transfusion Kit|U|1|N|N|||1|||||N|N
HO||MAJ|Catheter, Percutaneous, Intraspinal, Short Term|U|1|N|N|||1|||||N|N
HO||MDZ|Cleaners, Medical Devices|U|1|N|N|||1|||||N|N
HO||MQT|Pump, Drug Administration, Closed Loop|3||N|N|||2|||||N|N
HO||MTV|Device, Needle Destruction|3||N|N|||2|||||N|N
HO||NSX|Software, Transmission And Storage, Patient Data|N|6|N|N|||4|Non-alarming software that captures patient data from patient monitoring devices and transmits the data to the patient electronic medical record, where the data is stored.||||N|N
HO||OSS|Diabetes Take Home Kit|N|6|N|N|||7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
HO||PGO|Anti-Stick Glass Syringe|N|3|N|N|||7|Single use devices that are indicated for use as an accessory with sterile 1ML long staked needle prefilled ISO standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject, doctor prescribed medications, and individuals that assist self-injecting patients from accidental needle sticks.   Can be used on a wide range of patients including children and adults.|Cone shaped version|self injected needle|body|N|N
IM|CH|OUE|Micro Total Analysis Instrument System|2||N|N||862.2570|1|A micro total analysis instrument system is a clinical multiplex instrument intended to measure and sort signals generated by fluorescently-labeled immune complexes from a clinical sample on a microcapillary chip.  Signals may be quantified using laser-induced-fluorescence detection using filters on a photodiode or other detector.  It may integrate microfluidic chips with discrete zones for clinical sample and assay reagents; capillary electrophoresis; reagent handling system; dedicated instrument control; data acquisition software; raw data storage mechanisms; and other essential hardware components and signal reader unit. It is used with specific assays to comprise an assay test system.|Should not include microarray systems or standard immunoelectrophoresis systems.|A micro total analysis instrument system is an automated instrument for clinical multiplex test systems which uses electrokinetic mixing and isotachophoresis on a microfluidic chip to create immune complexes between target analyte(s) from a clinical specimen and fluorescently labeled antibodies. The complexes are detected and quantified using laser-induced-fluorescence detection after capillary gel electrophoresis. The chips contain discrete zones for loading and mixing the sample and assay reagents and for electrophoretic separation. It includes an automated chip loading and transport mechanism, reagent handling (fluidic) system, electrophoresis power supply, control and monitoring systems.|N/A|N|N
IM|HE|PDO|Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization|2||N|N||864.1870|1|The EGR1 FISH Probe Kit for specimen characterization  detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens.  This assay is used to characterize bone marrow specimens from patients with acute myeloid leukemia (AML) or myelodysplastic syndrome.  The assay results are to be interpreted by a qualified pathologist or cytogeneticist.|May include LSI EGR1 DNA probes, hybridization buffers, DAPI counterstain|Bone marrow cells from AML patients attached to microscope slides using standard cytogenetic procedures are used for this assay.  The resulting specimen DNA is denatured to single-stranded form and subsequently allowed to hybridize with the LSI EGR1 and LSI D5S23, D5S721 probes.  Following hybridization, the unbound probe is removed by a series of washes, and the nuclei are counterstained with DAPI, a DNA-specific stain that fluoresces blue.  Hybridization of the LSI EGR1 and LSI D5S23, D5S721 probes is viewed using a fluorescence microscope equipped with appropriate excitation and emission filters, allowing visualization of the orange and green fluorescent signals.|Bone marrow specimens|N|N
IM|HE|PFG|Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders|2||N|N||864.1870|1|DNA FISH probe kits for specimen characterization detect DNA probe targets on human chromosomes in bone marrow and peripheral blood specimens.|DNA probes labeled with fluorescent dyes, hybridization buffers, counterstain|Cells from bone marrow or peripheral blood are obtained from a patient with a hematological disorder. Cells are attached to microscope slides using standard cytogenetic procedures. The resulting specimen DNA is denatured to single-stranded form and subsequently allowed to hybridize with ore or more fluorescently labeled DNA probes. Following hybridization, the unbound probe is removed by a series of washes, and the nuclei are counterstained with I, a DNA-specific stain that fluoresces blue. Hybridization of the probe(s) is viewed using a fluorescence microscope equipped with appropriate excitation and emission filters, allowing visualization of the fluorescent signals.|Bone marrow and/or peripheral blood specimens|N|N
IM|IM|CFF|Immunoelectrophoretic, Immunoglobulins, (G, A, M)|2||N|P||866.5510|1|||||N|N
IM|IM|CFN|Method, Nephelometric, Immunoglobulins (G, A, M)|2||N|P||866.5510|1|||||N|N
IM|IM|CFQ|Radioimmunoassay, Immunoglobulins (G, A, M)|2||N|P||866.5510|1|||||N|N
IM|IM|CGM|Method, Immunodiffusion, Immunoglobulins (G, A, M)|2||N|P||866.5510|1|||||N|N
IM|IM|CHN|Immunochemical, Ceruloplasmin|2||N|N||866.5210|1|||||N|N
IM|IM|CZJ|Igd, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|CZK|Iga, Rhodamine, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|CZL|Iga, Peroxidase, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|CZM|Iga, Ferritin, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|CZN|Iga, Fitc, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|CZO|Inter-Alpha Trypsin Inhibitor, Antigen, Antiserum, Control|1||N|N||866.5890|4|||||N|N
IM|IM|CZP|Iga, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|CZQ|Bence-Jones Protein, Antigen, Antiserum, Control|2||N|P||866.5150|1|||||N|N
IM|IM|CZR|Hemopexin, Rhodamine, Antigen, Antiserum, Control|2||N|N||866.5490|4|||||N|N
IM|IM|CZS|Retinol-Binding Protein, Antigen, Antiserum, Control|1||N|N||866.5765|4|||||N|N
IM|IM|CZT|Hemopexin, Fitc, Antigen, Antiserum, Control|2||N|N||866.5490|4|||||N|N
IM|IM|CZW|Complement C3, Antigen, Antiserum, Control|2||N|P||866.5240|1|||||N|N
IM|IM|CZX|Hemopexin, Antigen, Antiserum, Control|2||N|N||866.5490|4|||||N|N
IM|IM|CZY|Complement C1s, Antigen, Antiserum, Control|2||N|P||866.5240|1|||||N|N
IM|IM|CZZ|Haptoglobin, Rhodamine, Antigen, Antiserum, Control|2||N|N||866.5460|4|||||N|N
IM|IM|DAA|Igg, Peroxidase, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|DAB|Haptoglobin, Fitc, Antigen, Antiserum, Control|2||N|N||866.5460|4|||||N|N
IM|IM|DAC|Complement C3b Activator, Antigen, Antiserum, Control|2||N|P||866.5260|1|||||N|N
IM|IM|DAD|Haptoglobin, Antigen, Antiserum, Control|2||N|N||866.5460|4|||||N|N
IM|IM|DAE|Complement C9, Antigen, Antiserum, Control|2||N|P||866.5240|1|||||N|N
IM|IM|DAF|Gamma Globulin, Fitc, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|DAG|Complement C8, Antigen, Antiserum, Control|2||N|P||866.5240|1|||||N|N
IM|IM|DAH|Gamma Globulin, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|DAI|Complement C1r, Antigen, Antiserum, Control|2||N|P||866.5240|1|||||N|N
IM|IM|DAJ|Free Secretory Component, Antigen, Antiserum, Control|2||N|N||866.5380|4|||||N|N
IM|IM|DAK|Complement C1q, Antigen, Antiserum, Control|2||N|P||866.5240|1|||||N|N
IM|IM|DAL|Fraction Iv-5, Antigen, Antiserum, Control|1||N|N||866.5360|4|||||N|N
IM|IM|DAM|Hemoglobin, Chain Specific, Antigen, Antiserum, Control|2||N|N||866.5470|7|||||N|N
IM|IM|DAN|Fibrinopeptide A, Antigen, Antiserum, Control|2||N|P||866.5350|1|||||N|N
IM|IM|DAO|Igm (Mu Chain Specific), Antigen, Antiserum, Control|2||N|P||866.5550|1|||||N|N
IM|IM|DAQ|Igg (Fd Fragment Specific), Antigen, Antiserum, Control|1||N|N||866.5540|4|||||N|N
IM|IM|DAS|Igg (Fc Fragment Specific), Antigen, Antiserum, Control|1||N|N||866.5530|4|||||N|N
IM|IM|DAW|Alpha-2-Ap-Glycoprotein, Antigen, Antiserum, Control|1||N|N||866.5425|4|||||N|N
IM|IM|DAY|Complement C5, Antigen, Antiserum, Control|2||N|P||866.5240|1|||||N|N
IM|IM|DBA|Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control|2||N|P||866.5250|1|||||N|N
IM|IM|DBC|Alpha 2, 2n-Glycoprotein, Antigen, Antiserum, Control|1||N|N||866.5425|4|||||N|N
IM|IM|DBE|Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control|2||N|P||866.5120|1|||||N|N
IM|IM|DBF|Ferritin, Antigen, Antiserum, Control|2||N|P||866.5340|1|||||N|N
IM|IM|DBH|Fc, Rhodamine, Antigen, Antiserum, Control|1||N|N||866.5530|4|||||N|N
IM|IM|DBI|Complement C4, Antigen, Antiserum, Control|2||N|P||866.5240|1|||||N|N
IM|IM|DBJ|Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control|2||N|N||866.5110|1|||||N|N
IM|IM|DBK|Fc, Fitc, Antigen, Antiserum, Control|1||N|N||866.5530|4|||||N|N
IM|IM|DBL|Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control|2||N|N||866.5660|1|||||N|N
IM|IM|DBM|Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control|2||N|P||866.5090|1|||||N|N
IM|IM|DBN|Fc, Antigen, Antiserum, Control|1||N|N||866.5530|4|||||N|N
IM|IM|DBT|Factor Xiii A, S, Antigen, Antiserum, Control|1||N|N||866.5330|4|||||N|N
IM|IM|DBY|Fab, Rhodamine, Antigen, Antiserum, Control|1||N|N||866.5520|4|||||N|N
IM|IM|DCB|Fab, Fitc, Antigen, Antiserum, Control|1||N|N||866.5520|4|||||N|N
IM|IM|DCE|Fab, Antigen, Antiserum, Control|1||N|N||866.5520|4|||||N|N
IM|IM|DCF|Albumin, Antigen, Antiserum, Control|2||N|N||866.5040|4|||||N|N
IM|IM|DCH|System, Test, C-Reactive Protein, Rhodamine|2||N|Y||866.5270|1|||||N|N
IM|IM|DCJ|Beta-Globulin, Antigen, Antiserum, Control|1||N|N||866.5160|4|||||N|N
IM|IM|DCK|C-Reactive Protein, Antigen, Antiserum, And Control|2||N|Y||866.5270|1|||||N|N
IM|IM|DCN|System, Test, C-Reactive Protein|2||N|Y||866.5270|1|||||N|N
IM|IM|DCO|Alpha-Globulin, Antigen, Antiserum, Control|1||N|N||866.5400|4|||||N|N
IM|IM|DCT|Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control|2||N|N||866.5210|1|||||N|N
IM|IM|DCY|Ceruloplasmin, Fitc, Antigen, Antiserum, Control|2||N|N||866.5210|1|||||N|N
IM|IM|DDB|Ceruloplasmin, Antigen, Antiserum, Control|2||N|N||866.5210|1|||||N|N
IM|IM|DDC|Thyroglobulin, Antigen, Antiserum, Control|2||N|N||866.5870|1|||||N|N
IM|IM|DDD|Transferrin, Rhodamine, Antigen, Antiserum, Control|2||N|P||866.5880|1|||||N|N
IM|IM|DDE|Carbonic Anhydrase C, Antigen, Antiserum, Control|1||N|N||866.5200|4|||||N|N
IM|IM|DDF|Prothrombin, Antigen, Antiserum, Control|1||N|N||866.5735|4|||||N|N
IM|IM|DDG|Transferrin, Antigen, Antiserum, Control|2||N|P||866.5880|1|||||N|N
IM|IM|DDH|Carbonic Anhydrase B, Antigen, Antiserum, Control|1||N|N||866.5200|4|||||N|N
IM|IM|DDI|Transferrin, Fitc, Antigen, Antiserum, Control|2||N|P||866.5880|1|||||N|N
IM|IM|DDJ|Thyroglobulin, Fitc, Antigen, Antiserum, Control|2||N|N||866.5870|1|||||N|N
IM|IM|DDK|Beta-2-Glycoprotein Iii, Antigen, Antiserum, Control|1||N|N||866.5440|4|||||N|N
IM|IM|DDL|Thyroglobulin, Rhodamine, Antigen, Antiserum, Control|2||N|N||866.5870|1|||||N|N
IM|IM|DDN|Beta-2-Glycoprotein I, Antigen, Antiserum, Control|1||N|N||866.5430|4|||||N|N
IM|IM|DDO|Myoglobin, Rhodamine, Antigen, Antiserum, Control|2||N|P||866.5680|1|||||N|N
IM|IM|DDR|Myoglobin, Antigen, Antiserum, Control|2||N|P||866.5680|1|||||N|N
IM|IM|DDS|Prealbumin, Fitc, Antigen, Antiserum, Control|1||N|N||866.5060|4|||||N|N
IM|IM|DDT|Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control|2||N|P||866.5620|1|||||N|N
IM|IM|DDX|Plasminogen, Antigen, Antiserum, Control|1||N|N||866.5715|4|||||N|N
IM|IM|DDY|Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control|2||N|P||866.5620|1|||||N|N
IM|IM|DDZ|Albumin, Fitc, Antigen, Antiserum, Control|2||N|N||866.5040|4|||||N|N
IM|IM|DEA|Myoglobin, Fitc, Antigen, Antiserum, Control|2||N|P||866.5680|1|||||N|N
IM|IM|DEB|Alpha-2-Macroglobulin, Antigen, Antiserum, Control|2||N|P||866.5620|1|||||N|N
IM|IM|DEC|Inter-Alpha Trypsin Inhibitor, Fitc, Antigen, Antiserum, Control|1||N|N||866.5890|4|||||N|N
IM|IM|DEF|Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control|1||N|N||866.5425|4|||||N|N
IM|IM|DEG|Lactoferrin, Antigen, Antiserum, Control|1||N|N||866.5570|4|||||N|N
IM|IM|DEH|Lambda, Antigen, Antiserum, Control|2||N|P||866.5550|1|||||N|N
IM|IM|DEI|Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control|2||N|P||866.5130|1|||||N|N
IM|IM|DEJ|Alpha-2-Glycoproteins, Antigen, Antiserum, Control|1||N|N||866.5425|4|||||N|N
IM|IM|DEK|Kappa, Rhodamine, Antigen, Antiserum, Control|2||N|P||866.5550|1|||||N|N
IM|IM|DEL|Lipoprotein X, Antigen, Antiserum, Control|1||N|N||866.5590|4|||||N|N
IM|IM|DEM|Alpha-1-Antitrypsin, Antigen, Antiserum, Control|2||N|P||866.5130|1|||||N|N
IM|IM|DEN|Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control|1||N|N||866.5420|4|||||N|N
IM|IM|DEO|Kappa, Fitc, Antigen, Antiserum, Control|2||N|P||866.5550|1|||||N|N
IM|IM|DEP|Lambda, Peroxidase, Antigen, Antiserum, Control|2||N|P||866.5550|1|||||N|N
IM|IM|DER|Alpha-1-Lipoprotein, Antigen, Antiserum, Control|2||N|P||866.5580|1|||||N|N
IM|IM|DES|Lambda, Fitc, Antigen, Antiserum, Control|2||N|P||866.5550|1|||||N|N
IM|IM|DET|Lactic Dehydrogenase, Antigen, Antiserum, Control|1||N|N||866.5560|4|||||N|N
IM|IM|DEW|Igg, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|DEX|Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control|1||N|N||866.5420|4|||||N|N
IM|IM|DEY|Igm, Peroxidase, Antigen, Antiserum, Control|2||N|P||866.5550|1|||||N|N
IM|IM|DEZ|Igm, Rhodamine, Antigen, Antiserum, Control|2||N|P||866.5550|1|||||N|N
IM|IM|DFB|Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control|2||N|P||866.5130|1|||||N|N
IM|IM|DFC|Lipoprotein, Low-Density, Antigen, Antiserum, Control|2||N|P||866.5600|1|||||N|N
IM|IM|DFD|Kappa, Peroxidase, Antigen, Antiserum, Control|2||N|P||866.5550|1|||||N|N
IM|IM|DFF|Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control|2||N|P||866.5080|1|||||N|N
IM|IM|DFG|Lambda, Rhodamine, Antigen, Antiserum, Control|2||N|P||866.5550|1|||||N|N
IM|IM|DFH|Kappa, Antigen, Antiserum, Control|2||N|P||866.5550|1|||||N|N
IM|IM|DFI|Total Spinal-Fluid, Antigen, Antiserum, Control|1||N|N||866.5860|4|||||N|N
IM|IM|DFJ|Albumin, Rhodamine, Antigen, Antiserum, Control|2||N|N||866.5040|4|||||N|N
IM|IM|DFK|Igg (Fab Fragment Specific), Antigen, Antiserum, Control|1||N|N||866.5520|4|||||N|N
IM|IM|DFL|Igm, Ferritin, Antigen, Antiserum, Control|2||N|P||866.5550|1|||||N|N
IM|IM|DFM|Ige, Ferritin, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|DFO|Igg, Rhodamine, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|DFQ|Sperm, Antigen, Antiserum, Control|1||N|N||866.5800|4|||||N|N
IM|IM|DFS|Igm, Fitc, Antigen, Antiserum, Control|2||N|P||866.5550|1|||||N|N
IM|IM|DFT|Igm, Antigen, Antiserum, Control|2||N|P||866.5550|1|||||N|N
IM|IM|DFX|Sperm, Fitc, Antigen, Antiserum, Control|1||N|N||866.5800|4|||||N|N
IM|IM|DFZ|Igg (Gamma Chain Specific), Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|DGA|Cohn Fraction Ii, Antigen, Antiserum, Control|1||N|N||866.5220|4|||||N|N
IM|IM|DGB|Seminal Fluid, Antigen, Antiserum, Control|1||N|N||866.5800|4|||||N|N
IM|IM|DGC|Ige, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|DGD|Igg, Ferritin, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|DGE|Igd, Rhodamine, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|DGG|Igd, Fitc, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|DGH|Igd, Peroxidase, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|DGI|Breast Milk, Rhodamine, Antigen, Antiserum, Control|1||N|N||866.5170|4|||||N|N
IM|IM|DGJ|Colostrum, Antigen, Antiserum, Control|1||N|N||866.5230|4|||||N|N
IM|IM|DGK|Igg, Fitc, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|DGL|Ige, Rhodamine, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|DGM|Breast Milk, Antigen, Antiserum, Control|1||N|N||866.5170|4|||||N|N
IM|IM|DGN|Breast Milk, Fitc, Antigen, Antiserum, Control|1||N|N||866.5170|4|||||N|N
IM|IM|DGO|Ige, Peroxidase, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|DGP|Ige, Fitc, Antigen, Antiserum, Control|2||N|Y||866.5510|1|||||N|N
IM|IM|DGQ|Whole Blood Plasma, Antigen, Antiserum, Control|1||N|N||866.5700|4|||||N|N
IM|IM|DGR|Whole Human Serum, Antigen, Antiserum, Control|1||N|N||866.5700|4|||||N|N
IM|IM|DGW|System, Test, Hypersensitivity Pneumonitis|2||N|N||866.5500|1|||||N|N
IM|IM|DGX|Ng1m(A), Antigen, Antiserum, Control|1||N|N||866.5065|4|||||N|N
IM|IM|DHB|System, Test, Radioallergosorbent (Rast) Immunological|2||N|N||866.5750|1|||||N|N
IM|IM|DHC|System, Test, Systemic Lupus Erythematosus|2||N|P||866.5820|1|||||N|N
IM|IM|DHF|D/Km-1, Antigen, Antiserum, Control|1||N|N||866.5065|4|||||N|N
IM|IM|DHI|Ng3m(Bo), Antigen, Antiserum, Control|1||N|N||866.5065|4|||||N|N
IM|IM|DHL|Protein, Complement, Antigen, Antiserum, Control|1||N|N||866.4100|4|||||N|N
IM|IM|DHN|Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control|2||N|Y||866.5100|1|||||N|N
IM|IM|DHQ|Ng3m(G), Antigen, Antiserum, Control|1||N|N||866.5065|4|||||N|N
IM|IM|DHR|System, Test, Rheumatoid Factor|2||N|Y||866.5775|1|||||N|N
IM|IM|DHX|System, Test, Carcinoembryonic Antigen|2||N|N||866.6010|1|||||N|N
IM|IM|DHY|Ng4m(A), Antigen, Antiserum, Control|1||N|N||866.5065|4|||||N|N
IM|IM|JFQ|P-Phenyl-Enediamine/Edta (Spectrophotometric), Ceruloplasmin|2||N|N||866.5210|1|||||N|N
IM|IM|JFR|Indirect Copper Assay, Ceruloplasmin|2||N|N||866.5210|1|||||N|N
IM|IM|JHR|Radioimmunoassay, Immunoglobulins (D, E)|2||N|P||866.5510|1|||||N|N
IM|IM|JKM|Immunochemical, Bence-Jones Protein|2||N|P||866.5150|1|||||N|N
IM|IM|JNL|Immunochemical, Thyroglobulin Autoantibody|2||N|Y||866.5870|1|||||N|N
IM|IM|JNM|Immunochemical, Transferrin|2||N|P||866.5880|1|||||N|N
IM|IM|JZG|System, Test, Beta-2-Microglobulin Immunological|2||N|P||866.5630|1|||||N|N
IM|IM|JZH|Factor B, Antigen, Antiserum, Control|2||N|N||866.5320|4|||||N|N
IM|IM|JZJ|Prealbumin, Antigen, Antiserum, Control|1||N|N||866.5060|4|||||N|N
IM|IM|JZO|System, Test, Thyroid Autoantibody|2||N|Y||866.5870|1|||||N|N
IM|IM|JZP|Plates, Ouchterlony Agar|1||N|N||866.4600|4|||||N|N
IM|IM|JZQ|Plates And Equipment, Radial Immunodiffusion|1||N|N||866.4800|4|||||N|N
IM|IM|JZR|Support Gels|1||N|N||866.4900|4|||||N|N
IM|IM|JZS|Electrophoresis Instrumentation|1||N|N||866.4500|4|||||N|N
IM|IM|JZT|Fluorometer|1||N|N||866.4520|4|||||N|N
IM|IM|JZW|Nephelometer|1||N|N||866.4540|4|||||N|N
IM|IM|JZX|Equipment, Rocket Immunoelectrophoresis|1||N|N||866.4830|4|||||N|N
IM|IM|KHT|Fraction V, Antigen, Antiserum, Control|1||N|N||866.5370|4|||||N|N
IM|IM|KTK|Reagent, Immunoassay, Carbonic Anhydrase B And C|1||N|N||866.5200|4|||||N|N
IM|IM|KTL|Anti-Dna Indirect Immunofluorescent Solid Phase|2||N|Y||866.5100|1|||||N|N
IM|IM|KTM|C3-Indirect Immunofluorescent Solid Phase|2||N|P||866.5240|1|||||N|N
IM|IM|KTN|System, Test, Infectious Mononucleosis|2||N|P||866.5640|1|||||N|N
IM|IM|KTO|Reagent, Immunoassay, Igg|1||N|N||866.5530|4|||||N|N
IM|IM|KTP|Complement C3b Activator Immunoassay Reagents|2||N|P||866.5260|1|||||N|N
IM|IM|KTQ|Reagent, Complement|1||N|N||866.4100|4|||||N|N
IM|IM|KTS|Second Antibody (Species Specific Anti-Animal Gamma Globulin)|2||N|P||866.5510|1|||||N|N
IM|IM|LJM|Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls|2||N|Y||866.5100|1|||||N|N
IM|IM|LKJ|Antinuclear Antibody, Antigen, Control|2||N|Y||866.5100|1|||||N|N
IM|IM|LKL|Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control|1||N|N||866.5420|4|||||N|N
IM|IM|LKO|Anti-Rnp Antibody, Antigen And Control|2||N|Y||866.5100|1|||||N|N
IM|IM|LKP|Anti-Sm Antibody, Antigen And Control|2||N|Y||866.5100|1|||||N|N
IM|IM|LLL|Extractable Antinuclear Antibody, Antigen And Control|2||N|Y||866.5100|1|||||N|N
IM|IM|LOJ|Kit, Test,Alpha-Fetoprotein For Testicular Cancer|2||N|N||866.6010|1|||||N|N
IM|IM|LRM|Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control|2||N|Y||866.5100|1|||||N|N
IM|IM|LSW|Anti-Dna Antibody, Antigen And Control|2||N|Y||866.5100|1|||||N|N
IM|IM|LTJ|Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers|2||N|N||866.6010|1|||||N|N
IM|IM|LTK|Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)|2||N|N||866.6010|1|||||N|N
IM|IM|LYE|Cytokeratins|2||N|P||866.5550|1|||||N|N
IM|IM|MGA|Alpha-1 Microglobulin, Antigen, Antiserum, Control|1||N|N||866.5400|4|||||N|N
IM|IM|MID|System, Test, Anticardiolipin Immunological|2||N|N||866.5660|1|||||N|N
IM|IM|MLE|Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control|2||N|N||866.5110|1|||||N|N
IM|IM|MLH|Strip, Hama Igg, Elisa, In Vitro Test System|2||N|P||866.5510|1|||||N|N
IM|IM|MMW|System, Test, Tumor Marker, Monitoring, Bladder|2||N|N||866.6010|1|||||N|N
IM|IM|MOB|Test System, Antineutrophil Cytoplasmic Antibodies (Anca)|2||N|N||866.5660|1|||||N|N
IM|IM|MOI|System, Test, Immunological, Antigen, Tumor|2||N|N||866.6010|1|||||N|N
IM|IM|MQA|Anti-Ribosomal P Antibodies|2||N|N||866.5100|1|||||N|N
IM|IM|MST|Antibodies, Gliadin|2||N|N||866.5750|1|||||N|N
IM|IM|MSV|System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)|2||N|N||866.5660|1|||||N|N
IM|IM|MSW|System,Test,Thyroglobulin|2||N|N||866.6010|1|||||N|N
IM|IM|MUT|Kit,Test For Nuclear Matrix(Numa)Protein(For Monitoring And Management Of Colorectal Cancer|2||N|N||866.6010|1|||||N|N
IM|IM|MVE|Biosensor,Immunoassay,Myoglobin|2||N|P||866.5680|1|||||N|N
IM|IM|MVJ|Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)|2||N|N||866.5660|1|||||N|N
IM|IM|MVM|Autoantibodies, Endomysial(Tissue Transglutaminase)|2||N|N||866.5660|1|||||N|N
IM|IM|NBO|Autoantibodies,Skin(Desmoglein 1 And Desmoglein 3)|2||N|N||866.5660|1|||||N|N
IM|IM|NBS|Autoantibodies,Lkm-1(Liver/Kidney Microsome,Type 1)|2||N|N||866.5660|1|||||N|N
IM|IM|NBT|Antibodies,Saccharomyces Cerevisiae (S.Cerevisiae)|2||N|N||866.5785|1|||||N|N
IM|IM|NCW|System, Test, Her-2/Neu, Monitoring|2||N|N||866.6010|1|||||N|N
IM|IM|NHS|Assay, Genotype, Hiv Drug Resistance, In Vitro|2||N|N||866.3950|1|Hiv-1 drug resistance genotyping||||N|N
IM|IM|NHX|Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)|2||N|N||866.5775|1|The device is used for the detection of anti-cyclic citrullinated peptide (CCP) antibodies in human serum or plasma as an aid in the diagnosis of rheumatoid arthritis.||||N|N
IM|IM|NIG|System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer|2||N|N||866.6010|1|An in vitro diagnostic test for the quantitative measurement of the CA 19-9 tumor associated antigen in human serum or plasma.  The test is intended as an aid in the management of patients with confirmed pancreatic cancer and serial monitoring of their response to therapy and disease progression.  The test should only be used in patients with serum and plasma CA 19-9 values above the cut-off at the time of diagnosis and in conjunction with other clinical methods.||||N|N
IM|IM|NIY|Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis|2||N|N||866.5660|1|ELISA for the detection of anti-SLA (soluble liver antigen) antibody of the IgG class. Intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis||||N|N
IM|IM|NJF|Antibodies, Anti-Actin, Anti-Smooth Muscle|2||N|N||866.5120|1|The device is used for the semi-quantitative detection of  IgG antibodies to the actin component of smooth muscle in human serum as an aid in the diagnosis of certain autoimmune liver diseases, e.g. autoimmune hepatitis.||||N|N
IM|IM|NOE|Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2|2||N|N||866.5600|1|The Lipoprotein-associated Phospholipase A2, Immunoassay, System, Test, is intended to measure lipoprotein-associated phospholipase A2 in human plasma in conjunction with clinical evaluation and other patient risk factors including biochemical analyses as an aid in predicting risk for coronary heat disease. This device differs from the classification regulation in that it is a different analyte, thus a NEW marker for predicting risk of coronary heart disease. This device is measuring an enzyme that is produced by macrophages where as the regulation is for the measurement of a lipoprotein.||||N|N
IM|IM|NPH|Antigen, Cartilage Oligomeric Matrix Protein (Comp)|2||N|N||866.5775|1|COMP ELISA is a quantitative enzyme-linked immunosorbent assay for detecting COMP (Cartilage Oligomeric Matrix Protein) in patient sera. The presence of elevated levels, when considered in conjunction with other laboratory and clinical findings, aids in identifying aggressive destruction of joint tissue in Rheumatoid Arthritis.||||N|N
IM|IM|NQD|Cardiac C-Reactive Protein, Antigen, Antiserum, And Control|2||N|N||866.5270|1|In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.||||N|N
IM|IM|NRI|Autoantibodies, Nuclear Pore Glycoprotein Gp210|2||N|N||866.5090|1|The device is used for the detection, in human serum or plasma, of autoantibodies to gp210 (nuclear pore glycoprotein gp210) as an aid in the diagnosis of primary biliary cirrhosis.||||N|N
IM|IM|NRX|Complement 4d (C4d) And Complement Receptor 1 (Cr1)|2||N|N||866.5820|1|The device is an indirect immunofluorescence assay utilizing monoclonal antibodies and flow cytometry in the quantitative determination of complement 4d (C4d) and complement receptor 1 (CR1) on the surface of erythrocytes from EDTA anti-coagulated whole blood. The C4d and CR1 results are used in a ratio as an aid in the diagnosis of systemic lupus erythematosus.||||N|N
IM|IM|NSF|Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment|2||N|N||866.6030|1|In vitro diagnostic test intended as a risk assessment test for the development of hepatocellular carcinoma (hcc) in patients with chronic liver diseases (cld).  Elevated afpl3% values (= 10%) have been shown to be associated with a nine-fold increase in the risk of developing hcc in the next 6-12 months.  Patients with elevated serum afpl3% should be more intensely evaluated for evidence of hcc according to the existing hcc practice guidelines in oncology.||||N|N
IM|IM|NST|Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking|2||N|N||866.5660|1|THE DEVICE IS AN IMMUNOASSAY INDICATED AS AN AID IN THE DIAGNOSIS OF MYASTHENIA GRAVIS, AN AUTOIMMUNE DISEASE CHARACTERIZED BY EXERCISE-INDUCED MUSCLE WEAKNESS TEMPORARILY RELIEVED BY CESSATION OF EXERCISE. AUTOANTIBODY, WHEN PRESENT IN SERUM, INTERFERES WITH THE BINDING OF ACETYLCHOLINE, A NEURAL TRANSMITTER AT THE JUNCTION OF NERVES WITH MUSCLES. AUTOANTIBODY CAN ALSO BIND TO OTHER PORTIONS OF THE ACETYLCHOLINE RECEPTOR WITHOUT INTERFERING WITH ACETYLCHOLINE BINDING. PRESENCE OF AUTOANTIBODY ALONG WITH CLINICAL SIGNS AND SYMPTOMS ARE USUALLY HIGHLY SUGGESTIVE OF MYASTHENIA GRAVIS. ACETYLCHOLINE RECEPTOR AUTOANTIBODY CAN ALSO OCCUR IN THE PRESENCE OF AUTOANTIBODIES TO OTHER BODY SUBSTANCES.||||N|N
IM|IM|NTH|System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays|2||N|N||866.4700|1|||||N|N
IM|IM|NTW|System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test|2||N|N||866.4070|1|System for collection, storage, and transport of whole blood and stabilization of intracellular rna with subsequent isolation and purification of host rna for rt-pcr used in molecular diagnostic testing||||N|N
IM|IM|NTY|System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer|2||N|N||866.6010|1|MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES.||||N|N
IM|IM|NUA|System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection|2||N|N||866.5900|1|The cftr gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the cftr gene.  It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (cf), carrier identification, and newborn screening.  This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation or population screening.|Multiplex qualitative amplification based detection system.  Should not include devices which use sequencing based detection methods.|Uses multiplex polymerase chain reaction to amplify specific DNA variants located on the CFTR gene using non-sequencing based methods.|Human peripheral whole blood or clinical samples.|N|N
IM|IM|NUM|Autoantibodies, Nuclear Body Protein, Sp100|2||N|N||866.5090|1|THE DEVICE IS USED FOR THE DETECTION, IN HUMAN SERUM OR PLASMA, OF AUTOANTIBODIES TO SP100 (NUCLEAR BODY PROTEIN SP100) AS AN AID IN THE DIAGNOSIS OF PRIMARY BILIARY CIRRHOSIS.||||N|N
IM|IM|NVA|Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma|2||N|N||866.6010|1|MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES.||||N|N
IM|IM|NWG|Autoantibodies, Glutamic Acid Decarboxylase (Gad)|2||N|N||866.5660|1|The device is used for the semi-quantitative determination of glutamic acid decarboxylase (GAD) autoantibodies in human serum as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).|Not applicable|Immunoassay|Not applicable|N|N
IM|IM|NXO|Calprotectin, Fecal|2||N|N||866.5180|1|The device is used for the measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation.  The device can be used as an aid in the diagnosis of inflammatory bowel disease (ibd), crohn's disease and ulcerative colitis and to differentiate ibd from irritable bowel syndrome.|n/a|Enzyme-linked immunosorbent assay (ELISA)|n/a|N|N
IM|IM|NYI|Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer|2||N|N||866.6040|1|A device which uses a gene expression profile of a breast cancer tumor, from patients stage i or stage ii lymph node negative, with a tumor size of <5.0 cm, to provide a risk assessment for distant recurrence of breast cancer.  The result is indicated for use only as a prognostic marker by physicians along with a number of other factors to assess the risk of recurrence of breast cancer.|RNA isolation kits, enzymes, fluorescent dyes, hybridization systems, computer|Uses Gene expression and computer algorithm that gives risk of recurrence.  Gene expression involves isolation of RNA from frozen tumor tissue sections, amplification of RNA and hybridization.|breast tumor tissue sections|N|N
IM|IM|NYO|Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody|2||N|N||866.5100|1|The anti-rna polymerase iii test is a semi-quantitative elisa for the detection of anti-rna polymerase iii antibodies in human serum.  The test result is used as an aid in the diagnosis of systemic sclerosis (ssc) in conjunction with the clinical and other laboratory findings.  For in-vitro diagnostic use.|Antibody ELISA kit, Antigen and Controls|The ELISA test result aids in the diagnosis of Systemic Sclerosis (SSc)|Blood Serum|N|N
IM|IM|OAU|Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma|2||N|N||866.6030|1|The test is intended to quantitatively measure dcp in human serum and use as an aid in the risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma (hcc) in conjunction with other laboratory findings, imaging studies and clinical assessment for risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma.|An assay kit containing specific antibodies, substrates and reaction columns|Immunochemical liquid-phase binding assay|peripheral blood|N|N
IM|IM|OBE|Anti-Ss-A 52 Autoantibodies|2||N|N||866.5100|1|The device is used for the detection, in human serum or plasma, of autoantibodies to SS-A 52.  The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.|The device consist of components/reagents to detect and semi-quantitatively measure autoantibodies to SS-A 52.|Enzyme-linked immunosorbent assay (ELISA) or enzyme immunoassay (EIA)|The assay is performed by testing human serum or plasma.|N|N
IM|IM|OBZ|Alpha-1-Antitrypsin Kit, Qualitative Phenotype|2||N|N||866.5130|1|The alpha-1-antitrypsin qualitative phenotype test result is used as an aid in the diagnosis of alpha-1-antitrypsin deficiency in conjunction with clinical and other laboratory findings. For in vitro diagnostic use only.|A1AT Antibody Isoelectric focusing gel qualitative phenotype kit and A1AT qualitative phenotype control|Isoelectric focusing gel qualitative test.|Blood serum|N|N
IM|IM|OCN|Insulin Autoantibody Kit|2||N|N||866.5660|1|The device is used for the semi-quantitative determination of insulin autoantibodies in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.|Not applicable|Immunoassay|Not applicable|N|N
IM|IM|OEG|Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230|2||N|N||866.5660|1|The device is intended as an aid in the diagnosis of bullous pemphigoid.|n/a|ELISA|n/a|N|N
IM|IM|OIF|Tyrosine Phosphatase (Ia-2) Autoantibody Assay|2||N|N||866.5660|1|The device is used for the semi-quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).|n/a|Radioimmunoassay|n/a|N|N
IM|IM|OIU|Test, Epithelial Ovarian Tumor Associated Antigen (He4)|2||N|N||866.6010|1|An enzyme immunometric assay for the quantitative determination of HE4 in human serum.   The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. It is not intended to estimate or assess the risk of disease outcomes of patients.|IVD|dual-site sandwich enzyme immunoassay of human serum or plasma; may be measured by stand-alone spectrophotometer or automated immunoassay analyzer|IVD|N|N
IM|IM|OKM|Antibodies, Outer-Membrane Proteins|2||N|N||866.5785|1|For the detection of anti-outer membrane protein (anti-OMP) antibodies in human serum.  To aid in the diagnosis of Crohn's Disease.|Comprised of antigen coated microtiter plate, enzyme conjugate, substrate, controls|Uses enzyme-linked, immunosorbent assay (ELISA) to identify the presence of anti-OMP antibodies.|human serum|N|N
IM|IM|OPN|Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex|2||N|N||866.5660|1|For the detection of autoantibodies to phosphatidylserine (PS), prothrombin (PT), or phosphatidylserine/prothrombin (PS/PT) complex in human serum or plasma.  To aid in the diagnosis of certain autoimmune thrombotic disorders such as anti-phospholipid syndrome and those secondary to systemic lupus erythematosus or other lupus-like diseases|Microtiter plate coated with purified antigen, enzyme labelled anti-human antibody substrate|ELISA|peripheral blood samples|N|N
IM|IM|OPX|Immunoglobulin A Kappa Heavy & Light Chain Combined|2||N|N||866.5510|1|Intended for the in-vitro quantification of iga kappa concentration in human serum.  The result is to be used with previously diagnosed iga multiple myeloma, in conjunction with other clinical and laboratory findings.  For previously diagnosed iga multiple myeloma patients.|Kit is composed of polyclonal monospecific sheep anti-IgA Kappa antibody, IgA Kappa calibrator, 2 IgA Kappa Controls, and IgA Kappa Supplementary Reagent|Nephelometric method|Blood serum|N|N
IM|IM|OPY|Igal Heavy & Light Chain Combined|2||N|N||866.5510|1|Intended for the in-vitro quantification of  iga lambda  concentration  in human serum. The result is to be used with previously diagnosed iga multiple myeloma, in conjunction with other clinical and laboratory findings. For previously diagnosed iga multiple myeloma patients.|The kit is composed of polyclonal monospecific sheep Anti-IgA Lambda antibody, IgA Lambda Calibrator, 2 IgA Lambda Controls, and IgA Lambda Supplementary Reagent|Nephelometric method|Blood serum|N|N
IM|IM|OQZ|Anti-Mutated Citrullinated Vimentin Igg|2||N|N||866.5775|1|For the semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma.|antigen coated microtiter wells, calibrators, controls, enzyme conjugate and substrate, buffer|Enzyme Immunoassay (ELISA)|Serum or plasma|N|N
IM|IM|OSK|Anti-Glutamate Receptor (Type Nmda) Ifa|2||N|N||866.5660|1|Intended for the qualitative determination of autoantibodies against glutamate receptor (type NMDA) in human serum. Used as an aid in the diagnosis of anti-glutamate receptor (type NMDA) autoimmune encephalitis in conjunction with other laboratory and clinical findings.|Solid, liquid|Immunofluorescent assay with multiple substrates|Human serum|N|N
IM|IM|OVK|Cytokeratin Fragments 21-1 Eia Kit|2||N|N||866.6010|1|The CYFRA 21-1 EIA kit is intended for the quantitative determination of soluble cytokeratin 19 fragments in human serum. The assay is to be used as an aid in monitoring disease progression during the course of disease and treatment in lung cancer patients. Serial testing for patient CYFRA 21-1 assay values should be used in conjunction with other clinical methods used for monitoring lung cancer.|plastic microtiter plate, plate reader system|Enzyme immunoassay to quantify soluble cytokeratin 19 in human serum.|Patient serum|N|N
IM|IM|OVQ|Chronic Lymphocytic Leukemia Fish Probe Kit|2||N|N||866.6040|1|The CLL FISH Probe Kit is intended to detect deletion of the LSI TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence in peripheral blood specimens from untreated patients with B-cell chronic lymphocytic leukemia (CLL). The assay may be used to dichotomize CLL (the 13q-, +12, or normal genotype group versus the 11q- or 17p- group) and may be used as an aid in determining disease prognosis in combination with additional biomarkers, morphology and other clinical information.|Reagents for B-cell chronic lymphocytic leukemia prognosis|Fluorescent in situ hybridization|B-cell chronic lymphocytic leukemia|N|N
IM|IM|OWK|Early Growth Response 1 (Egr) Fish Probe Kit|2||N|N||866.6040|1|The egr1 fish probe kit is intended to detect deletion of the lsi egr1 probe target in bone marrow specimens and may be used, in addition to cytogenetics, other biomarkers, morphology, and other clinical information, at the time of diagnosis as an aid in determining the prognosis of acute myeloid leukemia (aml) patients.|Device is a kit containing labeled FISH Probes|Detection of Early Growth Response Gene (EGR1) by fluorescence in-situ hybridization.|Not applicable|N|N
IM|IM|OWM|Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers|2||N|N||866.6040|1|Determines rate of increase of total prostate specific antigen at ultrasensitive concentration levels (picogram/ml serum), and identifies those patients following prostatectomies which are at reduced risk for recurrence of prostate cancer.|Capture antidbody, DNA-labeled antibody and PCR reagents. Software|Uses Immuno-PCR technology.  Ultrasensitive levels (picograms/ml concentration) of total prostate specific antigen are captured in a sandwich immunoassay using DNA-labeled antibody.  The sandwich is detected by Polymerase Chain Reaction exponential amplification.  Rate of increase in PSA concentration over a time period is determined by computer software.|Serum|N|N
IM|IM|OYL|Tryptase Assay System|2||N|N||866.5760|1|An in vitro diagnostic device intended as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings.|n/a|Immunoassay|plasma and serum samples|N|N
IM|IM|OYU|Dna-Probe Kit, Human Chromosome|2||N|N||866.4700|1|Detection of alpha satellite sequences in the centromere regions of human chromosomes in conjunction with routine diagnostic cytgenetic testing.  It is indicated for use as an adjunct to standard cytogenetic methaphase analysis a identifying and enumerating human chromosomes via fluorescence in situ hybridization (FISH) in metaphase cells and interphase nuclei of human cells.  It is not intended to be used as a stand alone assay for test reporting or clinical diagnosis.  FISH results are intended to be reported and interpreted only in conjunction with results of standard cytogenetic analysis, performed concurrently, utilizing the same patient specimen.|Reagents for identifying and enumerating human chromosomes|fluorescence in situ hybridization (FISH)|human cells|N|N
IM|IM|OZF|Tissue Rna Preservative For Collection, Storage, And Transportation|2||N|N||866.4070|1|The human tissue RNA preservation collection, storage, and transportation tube is a single-use, prefilled container intended for the collection, storage, and transportation of fresh human tissue specimens for subsequent RNA isolation and further molecular diagnostic testing.|consists of different sized tubes and volumes of preservative solution with a leak proof polyethylene cap.|Uses a special tissue preservation solution to preserve and stabilize RNA in tissue specimen for transport and later isolation and testing.|Human  tissue biopsy specimen.|N|N
IM|IM|PAF|Voltage Gated  Calcium Channel (Vgcc) Antibody Assay|2||N|N||866.5660|1|Intended for semi-quantitative determination of VGCC Antibody in human serum. The VGCC Ab may be present in patients diagnosed with Lambert-Eaton Syndrome (LEMS). The assay result is not to be used alone and to be used in conjunction with other clinical, electrodiagnostic and laboratory findings.|VGCC labeled with 125 Iodine-w-Conotoxin MVIIC (lyophilized) in 12x75 polysterene test tubes; Positive and negative controls; Total Binding & Non-Specific binding tubes; Anti-human IgG; Buffer; Wash solution|Radioimmunoassay (RIA) Assay using radioactive labeled material|Serum samples|N|N
IM|IM|PCG|21-Hydroxylase Antibody (21-Ohab)|2||N|N||866.5660|1|For semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.|RIA Assay Kit with reagents, antigen with I-125, calibrators, controls and assay buffer.|RIA|None|N|N
IM|IM|PCN|Immunoglobulin G Kappa Heavy And Light Chain Combined|2||N|N||866.5510|1|Intended for the in-vitro quantification of IgG kappa concentration in human serum.|Kit is composed of polyclonal monospecific sheep   anti-IgG kappa antibody, IgG kappa Calibrator, 2 IgG kappa Controls, and IgG kappa Supplementary Reagen|Nephelometric immunoassay method|Blood serum|N|N
IM|IM|PCO|Immunoglobulin G Lambda Heavy And Light Chain Combined|2||N|N||866.5510|1|Intended for the in-vitro quantification of IgG lambda concentration in human serum. The result is to be used with previously diagnosed IgG multiple myeloma, in conjunction with other clinical and laboratory findings.|Kit is composed of polyclonal monospecific sheep   anti-IgG lambda antibody, IgG lambda Calibrator, 2 IgG lambda Controls, and IgG lambda Supplementary Reagent|Nephelometric immunoassay method|Blood serum|N|N
IM|IM|PDE|Immunoglobulin M Kappa Heavy And Light Chain Combined|2||N|N||866.5510|1|Intended for the in-vitro quantification of IgM kappa concentration in human serum.  The result is to be used with previously diagnosed igm Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings.|Kit is composed of polyclonal monospecific sheep anti-IgM kappa antibody, IgM kappa Calibrator, 2 IgM kappa Controls, and IgM kappa Supplementary Reagent|Nephelometric immunoassay method|Human peripheral blood, serum|N|N
IM|IM|PDF|Immunoglobulin M Lambda Heavy And Light Chain Combined|2||N|N||866.5510|1|Intended for the in-vitro quantification of IgM lambda concentration in human serum.  The result is to be used with previously diagnosed IgM Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings.|Kit is composed of polyclonal monospecific sheep anti-IgM lambda antibody, IgM lambda Calibrator, 2 IgM lambda Controls, and IgM lambda Supplementary Reagent|Nephelometric immunoassay method|Peripheral human blood, serum|N|N
IM|IM|PET|Anti-Ss-A Ro60 Autoantibodies|2||N|N||866.5100|1|Ro60 assays are designed for the determination of IgG anti-Ro60 (SS-A Ro60) autoantibodies in human serum.  The presence of anti-Ro60 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus and Sjögren's Syndrome.|Consist of components/reagents to   detect and semi-quantitatively measure autoantibodies to SS-A 52.|Enzyme-linked immunosorbent assay (ELISA) or enzyme immunoassay (EIA)|The assay is performed by testing human serum or   plasma.|N|N
IM|IM|PFR|System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection|2||N|N||866.5900|1|The CFTR gene mutation detection system is used to simultaneously detect and identify a specified panel of mutations and variants in the CFTR gene using sequencing methods. It is intended for carrier screening, as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), and as an initial test to aid in the diagnosis of individuals with suspected CF. It is not intended for stand-alone diagnostic purposes, prenatal diagnostic, or pre-implantation screening.|Multiplex qualitative amplification based test system.  The device may include a use for newborn screening. Should not include devices using non-sequencing based detection methods.|The assay uses multiplex polymerase chain reaction to amplify and identify a specific panel of DNA variants located on the CFTR gene with DNA sequencing based detection methods.  Variants are identified by comparison to a specified reference sequence.|Human peripheral whole blood or clinical samples|N|N
IM|IM|PFS|System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection|2||N|N||866.5900|1|The CFTR gene variant detection system is used to sequence specified regions of the CFTR gene to detect gene variants. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), those with atypical or non-classic presentation of CF, or when other mutation panels have failed to identify both causative mutations. It is not intended for screening (carrier, newborn, population, or pre-implantation), prenatal diagnostic, or used for stand-alone diagnostic purposes|Multiplex qualitative amplification with DNA sequencing detection methods. Should not include devices using non-sequencing based detection methods.|Uses multiplex polymerase chain reaction to amplify and sequence specific regions of the CFTR gene with DNA sequencing based detection method. Variants are identified by comparison to a specified reference sequence.|Human peripheral whole blood or clinical samples|N|N
IM|IM|PFX|System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection|2||N|N||866.5920|1|A microarray-based, genome-wide, postnatal chromosomal abnormality detection system is used to qualitatively detect constitutional gains and losses in chromosomal copy numbers across the human genome using microarray methods.  It is intended as an aid in the postnatal diagnosis of developmental delay and/or intellectual disability (DD/ID), congenital anomalies, and dysmorphic features in conjunction with other clinical information currently used in postnatal diagnosis.  It is not intended to be used for standalone diagnostic purposes, prenatal or pre-implantation testing or screening, population screening, or for the detection of, or screening for, acquired or somatic genetic aberrations.|The test system consists of a multiplex qualitative amplification based test system which may utilize different types of microarrays and/or probes to represent the whole genome.  The device may integrate scanning, reagent handling, hybridization, washing, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit.     Should not include devices intended for prenatal use (i.e., diagnostic testing or screening) or for detection of, or screening for, acquired or somatic genetic aberrations (e.g., cancer).|The test system uses amplification of extracted genomic DNA followed by hybridization of the amplified, labeled fragments to homologous probes on a microarray.  The system uses signal intensities from the bound probes as the basis for determination of copy number variation.  Results may also include copy neutral loss of heterozygosity (CNLOH), and detection of mosaicism.   The microarray may use different probe sizes and densities across different regions of the genome.|Human peripheral whole blood or clinical samples|N|N
IM|IM|PGV|Anti-Phospholipase A2 Receptor|2||N|N||866.5880|1|Intended for the qualitative determination of IgG class autoantibodies against phospholipase A2 receptor (PLA2R) in human serum.|slides coated with cells, fluorescein-labelled detection antibody, positive and negative controls, buffers, embedding medium, cover glasses|indirect immunofluorescence assay (IFA)|serum|N|Y
IM|IM|PHF|Zinc Transporter 8 Auto-Antibody|2||N|N||866.5670|1|Intended for the in-vitro measurement (semi-quantitative) of Zinc Transporter 8 Antibody in human serum. The test result is to be used as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The assay result is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.|Assay Kit includes strip wells coated with ZnT8; 4 level calibrators; positive and negative controls; Zinc biotin; buffer; streptavidin peroxide; diluent; peroxide substrate; wash solution; stop solution|ELISA Assay|Serum (blood) sample|N|N
IM|IM|PIV|Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use|2||N|N||866.4750|1|Automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides.  It is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescent technology.  A trained operator must confirm all device generated results.|The system may include a fluorescence microscope with light source, a motorized microscope stage, dedicated instrument controls, a camera, a computer, a sample processor, and other hardware components.  The software may include fluorescent signal acquisition and processing software, data storage, data transferring mechanisms, and assay specific algorithms to suggest results.  A trained operator must confirm results generated with the device.|indirect immunofluorescent technology|human serum|N|N
IM|IM|PJI|Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System|2||N|N||866.5930|1|A newborn screening test for severe combined immunodeficiency (SCID) intended for the detection of T-cell receptor excision circle (TREC) genomic DNA isolated from newborn blood specimens dried on filter paper.  It is intended as an aid in screening newborns for severe combined immunodeficiency (SCID).|The test consists of primers and probes to amplify and detect genomic DNA obtained from newborn peripheral blood dried on filter paper.  The device includes reagents, instruments, software and consumables, and may integrate punching of a dried blood spot specimen from filter paper and may include controls and calibrators.  The instrumentation enables quantitative result output based comparison between amplified specific targeted sequence relative to a standard or normalizer (e.g., alternate gene sequence).  The instrumentation may also include mechanisms to store raw data.|The test system uses primers to amplify genomic DNA obtained from newborn peripheral blood dried on filter paper and probes to detect specific DNA targets of interest.|Human peripheral blood|N|N
IM|MI|MYR|Test,Donor,Syphilis,Antigens,Treponemal|2||N|P||866.3830|1|||||N|N
IM|MI|MZC|System,Detection,Bacterial, For Platelet Transfusion Products|1||N|N||866.2560|4|Cber||||N|N
IM|MI|NZB|Quality Control Material, Genetics, Dna|2||N|N||866.5910|1|Dna quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.  This type of device includes synthetic dna controls and cell-line based controls.|This type of device includes synthetic DNA controls and cell-line based controls.|No method, quality control material|No target area, IVD|N|N
IM|OB|ONX|Ovarian Adnexal Mass Assessment Score Test System|2||N|N||866.6050|1|An ovarian/adnexal mass assessment test is a devicem that measures one or more proteins in serum.  It yields a single result for the likelihood that an adnexal pelvic mass in a woman, for whom surgery is planned, is malignant.  The test isn for adjunctive use, in teh context of a negative primary clinical and radiological evaluation, to augmrent the identification of patienets whose gynecologic surgery requires oncology expertise and resources.|An ovarian/adnexal mass assessment test is a devicem that measures one or more proteins in serum.  It yields a single result for the likelihood that an adnexal pelvic mass in a woman, for whom surgery is planned, is malignant.  The test isn for adjunctive use, in teh context of a negative primary clinical and radiological evaluation, to augmrent the identification of patienets whose gynecologic surgery requires oncology expertise and resources.|An ovarian/adnexal mass assessment test is a devicem that measures one or more proteins in serum.  It yields a single result for the likelihood that an adnexal pelvic mass in a woman, for whom surgery is planned, is malignant.  The test isn for adjunctive use, in teh context of a negative primary clinical and radiological evaluation, to augmrent the identification of patienets whose gynecologic surgery requires oncology expertise and resources.|pelvic adenexal mass in women; ovaries|N|N
IM|TX|NVI|Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease|2||N|N||862.3100|1|The device is intended to suggest a systemic autoimmune disease association as an aid for differential diagnosis to be evaluated in conjunction with clinical findings and other laboratory tests.||||N|N
IM||KTJ|System, Test, Alpha-Fetoprotein, Ria|3||N|N|||2|||||N|N
IM||LOK|Kit, Test, Alpha-Fetoprotein For Neural Tube Defects|3||N|N|||2|||||N|N
IM||LTQ|Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum|3||N|N|||2|||||N|N
IM||MJB|Antigen, Cancer 549|3||N|N|||2|||||N|N
IM||MTF|Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer|3||N|N|||2|||||N|N
IM||MTG|Test,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions|3||N|N|||2|||||N|N
IM||MVD|System, Test, Her-2/Neu, Nucleic Acid Or Serum|3||N|N|||2|||||N|N
IM||MYZ|Kit,Test(Donors),For Bloodborne Pathogen|2||N|N|||1|Cber||||N|N
IM||MZA|Test,Equipment,Automated Bloodborne Pathogen|N|4|N|N|||3|||||N|N
IM||MZE|Test,Donor,Cmv|2||N|N|||1|Cber||||N|N
IM||MZF|Test, Hiv Detection|3||N|N|||2|||||N|N
IM||MZL|Kit,Test,Quality Control For Endotoxin|N|4|N|N|||3|||||N|N
IM||NAF|Antigen(Complexed),Prostate Specific,(Cpsa)|3||N|N|||2|||||N|N
IM||NAH|System,Test,Tumor Marker,For Detection Of Bladder Cancer|3||N|N|||2|||||N|N
IM||NSD|Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence|3||N|N|||2|In vitro diagnostic test to detect aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 locus via fluorescence in situ hybridization (fish) in urine specimens from persons suspected of having bladder cancer.  It is an adjunctive test for initial diagnosis of transitional cell carcinoma in symptomatic patients and subsequently monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.||||N|N
IM||NXG|Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion|3||N|N|||2|Topoisomerase ii alpha (top2a) fluorescence in situ hybridization (fish) kit is to detect the top2a gene copy number changes (amplification and deletion) in breast cancer using formalin-fixed, paraffin-embeded human breast cancer tissue specimen.|Assay kit contains pre-treatment solution, TOP2A/CEN-17 probe mix, buffers, and fluorescence mounting medium|Fluorescence in situ hybridization, manual method|Formalin-fixed, paraffin-embeded human breast cancer tissue specimen|N|N
IM||NYQ|Chromogenic In Situ Hybridisation, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer|3||N|N|||2|This device is intended to detect her2 gene amplification in formalin-fixed, paraffin-embedded breast carcinoma tissue sections using chromogenic in situ hybridization and brightfield microscopy.  Indicated as an aid in the assessment of patients for whom herceptin. (trastuzumab) treatment is being considered. Interpretation of test results must be made within the context of the patients clinical history by a qualified pathologist.|brightfield microscopy|Chromogenic In Situ Hybridization|breast carcinoma tissue sections|N|N
IM||OAW|Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma|f||N|N|||6|A quantitative measurement of soluble mesothelin related peptides (smrp) in human serum.  Measurement of smrp may aid in the monitoring of mesothelioma patients diagnosed with epithelioid or biphasic mesothelioma. Values must be interpreted in conjunction with all other available clinical laboratory data.|Assay kit including capturing and detecting antibody, buffers, controls and calibrators.|Enzyme-linked Immunosorbent Assay (ELISA)|In vitro diagnostic test usinh human serum.|N|N
IM||OCB|Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection|3||N|N|||2|A gene expression test for detection of cancer metastasisis an in vitro diagnostic test performed on tissue of interest from patients previously diagnosed with cancer.  Results from the test can be used to guide the intra-operative or post-operative decision to remove additional tissue. Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using an appropriate histological sampling scheme, is required.|Test consists of reagents, instrumentation, software and instructions needed to perform the test method.|In vitro replication, amplification and detection of mRNA representing the product of one or multiple genes from a cancerous tissue of interest.|Human tissue from known cancer patients, removed during biopsy procedures for detection of cancer metastases.|N|Y
IM||OQS|Laboratory Developed Test|N|6|N|N|||7|A clinical diagnostic test for use in the diagnosis of disease or other conditions that was developed by CLIA certified clinical laboratory for use in that laboratory. This product is neither an Analyte Specific Reagent nor are the components for Research Use Only. The reporting of adverse events is voluntary and registering and listing is not required.|In vitro diagnostic device|In vitro diagnostic device|In vitro diagnostic device|N|N
IM||OTR|Research Use Only/Immunology Devices|N|6|Y|N|||7|For research use only and for products imported into the US only.|N/A|N/A|N/A|N|N
IM||OWD|Somatic Gene Mutation Detection System|3||N|N|||2|The somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in dna extracted from human tumor tissues.|Test consists of reagents, instrumentation, software and instructions needed to perform the test method.|In vitro amplification and detection of genomic DNA representing a somatic gene mutation from a cancerous tissue of interest.|Human tissue from known cancer patients, removed during biopsy procedures.|N|N
IM||OYA|P2psa|3||N|N|||2|Quantitative determination of [-2]proPSA antigen in human serum to be used in combination with total PSA and free PSA to calculate the Prostate Health Index (phi)|Reagent packs, calibrators, controls, substrate and wash buffer|A two-site immunoenzymatic assay using paramagnetic particles coated with a mouse monoclonal anti-[-2]proPSA antibody to capture the [-2]proPSA and mouse monoclonal anti-PSA alkaline phosphatase conjugate that reacts with a chemiluminescent substrate to generate light.  Light production is measured with a luminometer.|peripheral blood|N|N
IM||OYM|Prostrate Cancer Genes Nucleic Acid Amplification Test System|3||N|N|||2|An in vitro nucleic acid amplification test that measures the concentration of prostate cancer genes.|Capture oligonucleotides, magnetic microparticles, transcription-based nucleic acid amplification reagents, chemiluminescent-labeled nucleic acid probes. luminometer, software|Utilizes nucleic acid probes and/or primers along with other reagents to detect prostrate cancer genes RNA from human specimens.|Currently this type of device is only utilized on urine specimens, but other specimen types may be possible.|N|N
IM||OYV|Trinucleotide Repeat Disorder Dna Test|N|3|N|N|||3|The trinucleotide repeat disorder dna test is an in vitro diagnostic device intended to amplify and detect the presence of specific triplet nucleotide repeats to aid in the diagnosis of genetic inherited disorders associated with mental retardation or intellectual disabilities, early reproductive failure, or progressive neuro- or muscular-degenerative disorders.  Identification and detection of specific full length gene fragment size and/or specific triplet repeats by polymerase chain reaction (pcr) of genomic dna purified from whole blood followed by fragment sizing on a dna genetic analyzer, capillary electrophoresis, or array-based platform to identify the number of triplet repeats.|Gene region specific amplification test system.  Should not include products not intended for export only or for products intended for re-importation into the USA|Uses polymerase chain reaction (PCR) and amplicon fragment sizing on a DNA genetic analyzer or capillary electrophoresis platform to determine the number of triplet repeats.|Peripheral human whole blood or human tissue.|N|N
IM||OYX|Bcr/Abl1 Quantitative Monitoring Test|N|3|N|N|||3|The bcr/abl1 quantitative monitoring test is a quantitative in vitro diagnostic device used to monitor the bcr/abl1 to abl1 ratio by reverse-transcriptase quantitative polymerase chain reaction (rq-pcr) on whole blood or bone marrow of diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukemia (cml) patients expressing b2a2, b3a2 or e1a2 fusion transcripts. It is intended for use as an aid in the assessment of complete cytogenetic response (ccyr) and major molecular response (mmr) .|Mulitplex quantitative chromosome translocation fusion transcript ratio amplification test system. Should not include products not intended for export only or for products intended for re-importation into the USA|The test uses mulitplex reverse-transcriptase quantitative polymerase chain reaction (RQ-PCR) to detect and determine BCR-ABL1 (b2a2, b3a2 and e1a2) fusion transcript levels relative to levels of ABL1 transcript on a real-time PCR instrument.|Peripheral human whole blood or bone marrow|N|N
IM||OYY|Leukemia Translocation Panel Multiplex Test|N|3|N|N|||3|The leukemia translocation panel multiplex test is a qualitative in vitro diagnostic device intended to identify specific fusion transcripts by reverse-transcriptase polymerase chain reaction (rt-pcr) from whole blood or bone marrow.  It is intended for use as an aid in the diagnosis of recurrent balanced or reciprocal translocation positive acute and chronic myeloid leukemia, acute lymphocytic or promyelocytic leukemias.|Mulitplex qualitative chromosome translocation amplification test system. Should not include products not intended for export only or for products intended for re-importation into the USA|The test uses a multiplex reverse-transcriptase polymerase chain reaction (RT-PCR) with multiplex fluorescent real-time PCR or bead-based array detection system|Peripheral human whole blood or bone marrow|N|N
IM||PAN|Braf Mutation Kit|N|3|N|N|||3|The BRAF mutation kit is a multiplex qualitative in vitro diagnostic device to identify specific BRAF mutations by multiplex polymerase chain reaction of genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) colorectal cancer or fine needle aspirated (FNA) thyroid tissue.  It is intended to aid in the treatment decisions and risk stratification of patients diagnosed with colorectal or papillary thyroid cancer.|Multiplex qualitative DNA mutation amplification and detection test system. Should not include products not intended for export only or for products intended for re-importation into the USA.|The test uses multiplex qualitative polymerase chain reaction (PCR) and a multiplex test system (e.g., liquid bead array cytometry, etc.) to amplify and detect specific BRAF mutations.|Formalin-fixed paraffin-embedded (FFPE) colorectal cancer or fine needle aspirated (FNA) thyroid tissue.|N|N
IM||PCZ|Investigational Use Only - Immunology|N|6|Y|N|||7|Investigational use only and for products imported into the US only.|N/A|N/A|N/A|N|N
IM||PIL|Test For Periprosthetic Joint Infection|N|3|N|N|||7|a qualitative in vitro diagnostic device intended as an adjunct for the detection of periprosthetic joint infection (PJI) in synovial fluid of patients experiencing pain and/or inflammation in a replacement joint.|test|a qualitative in vitro diagnostic device intended as an adjunct for the detection of periprosthetic joint infection (PJI) in synovial fluid of patients experiencing pain and/or inflammation in a replacement joint.|In Vitro|N|N
MI|CH|MJX|Kit, Serological, Positive Control|1||N|Y||862.1660|1|||||N|N
MI|CH|MJY|Kit, Serological, Negative Control|1||N|Y||862.1660|1|||||N|N
MI|CH|MJZ|Kit, Direct Antigen, Positive Control|1||N|Y||862.1660|1|||||N|N
MI|CH|MKA|Kit, Direct Antigen, Negative Control|1||N|Y||862.1660|1|||||N|N
MI|IM|OUY|Trichomonas Vaginalis Nucleic Acid Amplification Test System|2||N|N||866.3860|1|In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic patients|May include target capture, transcription-mediated amplification, semi automated analyzer|Uses target capture, transcription-mediated amplification and hybridization protection assay technologies to stream line specimen processing, amplify target rRNA and detect amplicon respectively|Vaginal, cervical,endocervical, urogenital and gynecological specimens|N|N
MI|IM|PII|Candida Species Nucleic Acid Detection System|2||N|N||866.3960|1|The Candida species nucleic acid detection system is a qualitative panel for the direct detection of Candida species in whole blood specimens from patients with symptoms of, or medical conditions predisposing the patients to, invasive fungal infections.  The test is indicated for the presumptive diagnosis of candidemia. The test is performed independent of blood culture. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification.|The Candida species nucleic acid detection system consists of reagents and disposables and accompanying positive and negative controls.  The associated instrumentation performs the amplification of the Candida nucleic acid, detects the amplified products, and reports results.|A multiplexed nucleic acid amplification assay that amplifies and detects Candida DNA in whole blood specimens.|Nucleic acids of Candida species.|N|N
MI|MI|GLZ|Antigens, If, Toxoplasma Gondii|2||N|P||866.3780|1|||||N|N
MI|MI|GMA|Antisera, Fluorescent, Sporothrix Schenekii|1||N|N||866.3680|4|||||N|N
MI|MI|GMB|Light, Wood'S, Fluorescence|1||Y|N||866.2600|4|||||N|N
MI|MI|GMD|Antisera, Latex Agglutination, Cryptococcus Neoformans|2||N|N||866.3165|4|||||N|N
MI|MI|GME|Antisera, Fluorescent, Cryptococcus Neoformans|2||N|N||866.3165|4|||||N|N
MI|MI|GMG|Antigen, Latex Agglutination, Coccidioides Immitis|2||N|N||866.3135|4|||||N|N
MI|MI|GMH|Antiserum, Positive Control, Coccidioides Immitis|2||N|N||866.3135|4|||||N|N
MI|MI|GMI|Antigen, Cf And/Or Id, Coccidioides Immitis|2||N|N||866.3135|4|||||N|N
MI|MI|GMJ|Antigens, Histoplasma Capsulatum, All|2||N|N||866.3320|4|||||N|N
MI|MI|GMK|Antiserum, Positive Control, Histoplasma Capsulatum|2||N|N||866.3320|4|||||N|N
MI|MI|GML|Antisera, Fluorescent, Histoplasma Capsulatum|2||N|N||866.3320|4|||||N|N
MI|MI|GMM|Antigens, Iha, Toxoplasma Gondii|2||N|P||866.3780|1|||||N|N
MI|MI|GMN|Antigens, Cf, Toxoplasma Gondii|2||N|P||866.3780|1|||||N|N
MI|MI|GMO|Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.|2||N|N||866.3220|4|||||N|N
MI|MI|GMP|Antisera, Control For Nontreponemal Tests|2||N|P||866.3820|1|||||N|N
MI|MI|GMQ|Antigens, Nontreponemal, All|2||N|P||866.3820|1|||||N|N
MI|MI|GMR|Sera, Reactive And Non-Specific Control, Fta-Abs Test|2||N|P||866.3830|1|||||N|N
MI|MI|GMS|Anti-Human Globulin, Fta-Abs Test|2||N|P||866.3830|1|||||N|N
MI|MI|GMT|Antigens, Ha, Treponema Pallidum|2||N|P||866.3830|1|||||N|N
MI|MI|GMW|Test, Sorbent, Fta-Abs|2||N|P||866.3830|1|||||N|N
MI|MI|GMX|Antisera, Fluorescent Antibody For Fta-Abs Test|2||N|P||866.3830|1|||||N|N
MI|MI|GMY|Antisera, Fluorescent, All Types, Escherichia Coli|1||N|N||866.3255|4|||||N|N
MI|MI|GMZ|Antigens, All Types, Escherichia Coli|1||N|N||866.3255|4|||||N|N
MI|MI|GNA|Antisera, All Types, Escherichia Coli|1||N|N||866.3255|4|||||N|N
MI|MI|GNB|Antisera, All Types, Shigella Spp.|2||N|N||866.3660|4|||||N|N
MI|MI|GNC|Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.|2||N|N||866.3550|4|||||N|N
MI|MI|GND|Antigen, Iha, T. Cruzi|1||N|Y||866.3870|1|||||N|N
MI|MI|GNE|Antigen, Latex Agglutination, T. Cruzi|1||N|Y||866.3870|1|||||N|N
MI|MI|GNF|Antigen, Cf, T. Cruzi|1||N|Y||866.3870|1|||||N|N
MI|MI|GNG|Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6|1||N|N||866.3145|4|||||N|N
MI|MI|GNH|Antigen, Fluorescent Antibody Test, Schistosoma Mansoni|1||N|N||866.3600|4|||||N|N
MI|MI|GNI|Antisera, Neutralization, Echovirus 1-34|1||N|N||866.3205|4|||||N|N
MI|MI|GNJ|Antigens, Ha, Echovirus 1-34|1||N|N||866.3205|4|||||N|N
MI|MI|GNK|Antisera, Cf, Echovirus 1-34|1||N|N||866.3205|4|||||N|N
MI|MI|GNL|Antigens, Cf (Including Cf Control), Echovirus 1-34|1||N|N||866.3205|4|||||N|N
MI|MI|GNM|Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6|1||N|N||866.3145|4|||||N|N
MI|MI|GNN|Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6|1||N|N||866.3145|4|||||N|N
MI|MI|GNO|Antisera, Cf, Coxsackievirus A 1-24, B 1-6|1||N|N||866.3145|4|||||N|N
MI|MI|GNP|Antiserum, Cf, Epstein-Barr Virus|1||N|Y||866.3235|1|||||N|N
MI|MI|GNQ|Antigen, Cf (Including Cf Control), Epstein-Barr Virus|1||N|Y||866.3235|1|||||N|N
MI|MI|GNR|Antisera, Neutralization, Influenza Virus A, B, C|1||N|N||866.3330|4|||||N|N
MI|MI|GNS|Antisera, Hai, Influenza Virus A, B, C|1||N|N||866.3330|4|||||N|N
MI|MI|GNT|Antigens, Ha (Including Ha Control), Influenza Virus A, B, C|1||N|N||866.3330|4|||||N|N
MI|MI|GNW|Antisera, Cf, Influenza Virus A, B, C|1||N|N||866.3330|4|||||N|N
MI|MI|GNX|Antigens, Cf (Including Cf Control), Influenza Virus A, B, C|1||N|N||866.3330|4|||||N|N
MI|MI|GNY|Antisera, Fluorescent, Adenovirus 1-33|1||N|N||866.3020|4|||||N|N
MI|MI|GNZ|Antisera, Neutralization, Adenovirus 1-33|1||N|N||866.3020|4|||||N|N
MI|MI|GOA|Antisera, Cf, Adenovirus 1-33|1||N|N||866.3020|4|||||N|N
MI|MI|GOB|Antigens, Ha (Including Ha Control), Adenovirus 1-33|1||N|N||866.3020|4|||||N|N
MI|MI|GOC|Antisera, Hai, Adenovirus 1-33|1||N|N||866.3020|4|||||N|N
MI|MI|GOD|Antigens, Cf (Including Cf Control), Adenovirus 1-33|1||N|N||866.3020|4|||||N|N
MI|MI|GOE|Antisera, Fluorescent, Poliovirus 1-3|1||N|N||866.3405|4|||||N|N
MI|MI|GOF|Antisera, Neutralization, Poliovirus 1-3|1||N|N||866.3405|4|||||N|N
MI|MI|GOG|Antisera, Cf, Poliovirus 1-3|1||N|N||866.3405|4|||||N|N
MI|MI|GOH|Antigens, Cf (Including Cf Control), Poliovirus 1-3|1||N|N||866.3405|4|||||N|N
MI|MI|GOI|Antiserum, Fluorescent, Rabies Virus|2||N|N||866.3460|1|||||N|N
MI|MI|GOJ|Antisera, Neutralization, Rubella|2||N|P||866.3510|1|||||N|N
MI|MI|GOK|Antisera, Hai (Including Hai Control), Rubella|2||N|P||866.3510|1|||||N|N
MI|MI|GOL|Antigen, Ha (Including Ha Control), Rubella|2||N|P||866.3510|1|||||N|N
MI|MI|GOM|Antisera, Cf, Rubella|2||N|P||866.3510|1|||||N|N
MI|MI|GON|Antigen, Cf (Including Cf Control), Rubella|2||N|P||866.3510|1|||||N|N
MI|MI|GOO|Antisera, Fluorescent, All Globulins, Salmonella Spp.|2||N|N||866.3550|4|||||N|N
MI|MI|GOP|Antisera, C. Acnes (553, 605)|1||N|N||866.3140|4|||||N|N
MI|MI|GOS|Antiserum, Fluorescent, C. Diphtheriae|1||N|N||866.3140|4|||||N|N
MI|MI|GOT|Antigen, B. Parapertussis|1||N|N||866.3065|4|||||N|N
MI|MI|GOW|Antisera, Agglutinating, B. Parapertussis|1||N|N||866.3065|4|||||N|N
MI|MI|GOX|Antigen, B. Pertussis|1||N|N||866.3065|4|||||N|N
MI|MI|GOY|Antisera, Agglutinating, B. Pertussis, All|1||N|N||866.3065|4|||||N|N
MI|MI|GOZ|Antisera, Fluorescent, B. Pertussis|1||N|N||866.3065|4|||||N|N
MI|MI|GPD|Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus|1||N|N||866.3200|4|||||N|N
MI|MI|GPE|Antisera, Positive Control, Echinococcus Spp.|1||N|N||866.3200|4|||||N|N
MI|MI|GPF|Antigen, Agglutinating, Echinococcus Spp.|1||N|N||866.3200|4|||||N|N
MI|MI|GPG|Antigen, Latex Agglutination, Trichinella Spiralis|1||N|N||866.3850|4|||||N|N
MI|MI|GPH|Antiserum, Bentonite Flocculation, Trichinella Spiralis|1||N|N||866.3850|4|||||N|N
MI|MI|GPI|Antigen, Bentonite Flocculation, Trichinella Spiralis|1||N|N||866.3850|4|||||N|N
MI|MI|GPJ|Antiserum, Fluorescent, Q Fever|1||N|N||866.3500|4|||||N|N
MI|MI|GPK|Antiserum, Rickettsialpox|1||N|N||866.3500|4|||||N|N
MI|MI|GPM|Antiserum, Murine Typhus Fever|1||N|N||866.3500|4|||||N|N
MI|MI|GPN|Antiserum, Typhus Fever|1||N|N||866.3500|4|||||N|N
MI|MI|GPO|Antigen, Cf, Typhus Fever Group|1||N|N||866.3500|4|||||N|N
MI|MI|GPP|Antiserum, Rocky Mountain Spotted Fever|1||N|N||866.3500|4|||||N|N
MI|MI|GPQ|Antigen, Cf, Spotted Fever Group|1||N|N||866.3500|4|||||N|N
MI|MI|GPR|Antiserum, Cf, Q Fever|1||N|N||866.3500|4|||||N|N
MI|MI|GPS|Antigen, Cf, Q Fever|1||N|N||866.3500|4|||||N|N
MI|MI|GPT|Antiserum, Cf, Psittacosis (Chlamydia Group)|1||N|Y||866.3120|1|||||N|N
MI|MI|GPW|Antigen, Cf, Psittacosis (Chlamydia Group)|1||N|Y||866.3120|1|||||N|N
MI|MI|GPX|Antisera, Neutralizion, Reovirus 1-3|1||N|N||866.3470|4|||||N|N
MI|MI|GPY|Antisera, Hai, Reovirus 1-3|1||N|N||866.3470|4|||||N|N
MI|MI|GPZ|Antisera, Cf, Reovirus 1-3|1||N|N||866.3470|4|||||N|N
MI|MI|GQA|Antigens, Ha (Including Ha Control), Reovirus 1-3|1||N|N||866.3470|4|||||N|N
MI|MI|GQB|Antigens, Cf (Including Cf Control), Reovirus 1-3|1||N|N||866.3470|4|||||N|N
MI|MI|GQC|Antisera, Cf, Equine Encephalitis Virus, Eee, Wee|1||N|N||866.3240|4|||||N|N
MI|MI|GQD|Antigens, Cf (Including Cf Control), Equine Encephalitis Virus, Eee, Wee|1||N|N||866.3240|4|||||N|N
MI|MI|GQE|Antisera, Neutralization, All Types, Rhinovirus|1||N|N||866.3490|4|||||N|N
MI|MI|GQF|Antiserum, Neutralization, Respiratory Syncytial Virus|1||N|N||866.3480|4|||||N|N
MI|MI|GQG|Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus|1||N|N||866.3480|4|||||N|N
MI|MI|GQH|Antigen, Cf (Including Cf Control), Cytomegalovirus|2||N|P||866.3175|1|||||N|N
MI|MI|GQI|Antiserum, Cf, Cytomegalovirus|2||N|P||866.3175|1|||||N|N
MI|MI|GQJ|Antiserum, Cf, Lymphocytic Choriomeningitis Virus|1||N|N||866.3360|4|||||N|N
MI|MI|GQK|Antigen, Cf, Lymphocytic Choriomeningitis Virus|1||N|N||866.3360|4|||||N|N
MI|MI|GQL|Antisera, Fluorescent, Herpesvirus Hominis 1,2|2||N|N||866.3305|1|||||N|N
MI|MI|GQM|Antisera, Neutralization, Herpesvirus Hominis|2||N|N||866.3305|1|||||N|N
MI|MI|GQN|Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2|2||N|N||866.3305|1|||||N|N
MI|MI|GQO|Antisera, Cf, Herpesvirus Hominis 1,2|2||N|N||866.3305|1|||||N|N
MI|MI|GQP|Antisera, Neutralization, Parainfluenza Virus 1-4|1||N|N||866.3400|4|||||N|N
MI|MI|GQQ|Antisera, Hai, Parainfluenza Virus 1-4|1||N|N||866.3400|4|||||N|N
MI|MI|GQR|Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4|1||N|N||866.3400|4|||||N|N
MI|MI|GQS|Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4|1||N|N||866.3400|4|||||N|N
MI|MI|GQT|Antisera, Cf, Parainfluenza Virus 1-4|1||N|N||866.3400|4|||||N|N
MI|MI|GQW|Antigen, Cf, (Including Cf Control), Varicella-Zoster|2||N|P||866.3900|1|||||N|N
MI|MI|GQX|Antiserum, Cf, Varicella-Zoster|2||N|P||866.3900|1|||||N|N
MI|MI|GQY|Antigen, Ha (Including Ha Control), Mumps Virus|1||N|N||866.3380|4|||||N|N
MI|MI|GQZ|Antiserum, Neutralization, Mumps Virus|1||N|N||866.3380|4|||||N|N
MI|MI|GRA|Antiserum, Fluorescent, Mumps Virus|1||N|N||866.3380|4|||||N|N
MI|MI|GRB|Antiserum, Cf, Mumps Virus|1||N|N||866.3380|4|||||N|N
MI|MI|GRC|Antigen, Cf (Including Cf Control), Mumps Virus|1||N|N||866.3380|4|||||N|N
MI|MI|GRD|Antiserum, Hai, Mumps Virus|1||N|N||866.3380|4|||||N|N
MI|MI|GRE|Antiserum, Fluorescent, Rubeola|1||N|N||866.3520|4|||||N|N
MI|MI|GRF|Antiserum, Cf, Rubeola|1||N|N||866.3520|4|||||N|N
MI|MI|GRG|Antiserum, Hai, Rubeola|1||N|N||866.3520|4|||||N|N
MI|MI|GRH|Antigen, Ha (Including Ha Control), Rubeola|1||N|N||866.3520|4|||||N|N
MI|MI|GRI|Antiserum, Neutralization, Rubeola|1||N|N||866.3520|4|||||N|N
MI|MI|GRJ|Antigen, Cf, (Including Cf Control), Rubeola|1||N|N||866.3520|4|||||N|N
MI|MI|GRK|Antisera, Fluorescent, Echovirus 1-34|1||N|N||866.3205|4|||||N|N
MI|MI|GRL|Antigens, All Groups, Salmonella Spp.|2||N|N||866.3550|4|||||N|N
MI|MI|GRM|Antisera, All Groups, Salmonella Spp.|2||N|N||866.3550|4|||||N|N
MI|MI|GRO|Antisera, Fluorescent, All Types, Hemophilus Spp.|2||N|N||866.3300|4|||||N|N
MI|MI|GRP|Antisera, All Types, H. Influenza|2||N|N||866.3300|4|||||N|N
MI|MI|GRT|Antiserum, Fluorescent, Mycobacterium Tuberculosis|1||N|Y||866.3370|1|||||N|N
MI|MI|GRW|Antisera, All Fluorescent, Leptospira Spp.|2||N|N||866.3350|4|||||N|N
MI|MI|GRX|Antisera, All Leptospira Spp.|2||N|N||866.3350|4|||||N|N
MI|MI|GRY|Antigens, All, Leptospira Spp.|2||N|N||866.3350|4|||||N|N
MI|MI|GRZ|Antisera, Fluorescent, All, Mycoplasma Spp.|1||N|N||866.3375|4|||||N|N
MI|MI|GSA|Antisera, All Mycoplasma Spp.|1||N|N||866.3375|4|||||N|N
MI|MI|GSB|Antigens, Cf, All, Mycoplasma Spp.|1||N|N||866.3375|4|||||N|N
MI|MI|GSD|Antiserum, Fluorescent, Erysipelothrix Rhusiopathiae|1||N|N||866.3250|4|||||N|N
MI|MI|GSE|Antiserum, Erysipelothrix Rhusiopathiae|1||N|N||866.3250|4|||||N|N
MI|MI|GSF|Antigen, Erysipelothrix Rhusiopathiae|1||N|N||866.3250|4|||||N|N
MI|MI|GSG|Antisera, Fluorescent, All Types, Listeria Monocytogenes|1||N|N||866.3355|4|||||N|N
MI|MI|GSH|Antisera, All Types, Listeria Monocytogenes|1||N|N||866.3355|4|||||N|N
MI|MI|GSI|Antigens, Slide And Tube, All Types, Listeria Monocytogenes|1||N|N||866.3355|4|||||N|N
MI|MI|GSJ|Antiserum, Fluorescent, Francisella Tularensis|2||N|N||866.3280|4|||||N|N
MI|MI|GSK|Antiserum, Francisella Tularensis|2||N|N||866.3280|4|||||N|N
MI|MI|GSL|Antigens, Slide And Tube, Francisella Tularensis|2||N|N||866.3280|4|||||N|N
MI|MI|GSM|Antisera, Fluorescent, Brucella Spp.|2||N|N||866.3085|4|||||N|N
MI|MI|GSN|Antiserum, Positive And Negative Febrile Antigen Control Serum|2||N|N||866.3085|4|||||N|N
MI|MI|GSO|Antigens (Febrile), Agglutination, Brucella Spp.|2||N|N||866.3085|4|||||N|N
MI|MI|GSP|Antiserum, Fluorescent, Campylobacter Fetus|1||N|Y||866.3110|1|||||N|N
MI|MI|GSQ|Antiserum, Vibrio Cholerae, All Varieties|2||N|N||866.3930|4|||||N|N
MI|MI|GSR|Antisera, Fluorescent, Pseudomonas Pseudomallei|2||N|N||866.3415|4|||||N|N
MI|MI|GSS|Antisera, Fluorescent, Pseudomonas Aeruginosa|2||N|N||866.3415|4|||||N|N
MI|MI|GST|Antiserum, Pseudomonas Pseudomallei|2||N|N||866.3415|4|||||N|N
MI|MI|GSW|Antiserum, Flavobacterium Meningosepticum, All Groups|1||N|N||866.3270|4|||||N|N
MI|MI|GSX|Antisera, Acinetobacter Calcoaceticus, All Varieties|1||N|N||866.3010|4|||||N|N
MI|MI|GSY|Antisera, Fluorescent, All Globulins, Proteus Spp.|1||N|N||866.3410|4|||||N|N
MI|MI|GSZ|Antigens, Febrile (Weil-Felix), All Groups|1||N|N||866.3410|4|||||N|N
MI|MI|GTA|Antisera, All, Serratia Marcesans|1||N|N||866.3630|4|||||N|N
MI|MI|GTB|Antisera, Fluorescent, All Types, Klebsiella Spp.|1||N|N||866.3340|4|||||N|N
MI|MI|GTC|Antisera, All Types, Klebsiella Spp.|1||N|N||866.3340|4|||||N|N
MI|MI|GTD|Antisera, Fluorescent, All Globulins, Shigella Spp.|2||N|N||866.3660|4|||||N|N
MI|MI|GTE|Antisera, Arizona Spp., All|1||N|N||866.3035|4|||||N|N
MI|MI|GTF|Antisera, Bethesda - Ballerup Polyvalent, Citrobacter Spp.|1||N|N||866.3125|4|||||N|N
MI|MI|GTH|Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae|2||N|P||866.3390|1|||||N|N
MI|MI|GTI|Antisera, Fluorescent, All Groups, N. Meningitidis|2||N|P||866.3390|1|||||N|N
MI|MI|GTJ|Antisera, All Groups, N. Meningitidis|2||N|P||866.3390|1|||||N|N
MI|MI|GTL|Phages, Staphylococcal Typing, All Types|1||N|N||866.2050|4|||||N|N
MI|MI|GTN|Antisera, Fluorescent, All Types, Staphylococcus Spp.|1||N|N||866.3700|4|||||N|N
MI|MI|GTO|Anti-Streptokinase|1||N|N||866.3720|4|||||N|N
MI|MI|GTP|Exoenzymes, Multiple, Streptococcal|1||N|N||866.3720|4|||||N|N
MI|MI|GTQ|Antistreptolysin - Titer/Streptolysin O Reagent|1||N|N||866.3720|4|||||N|N
MI|MI|GTR|Antideoxyribonuclease, Streptococcus Spp.|1||N|N||866.3720|4|||||N|N
MI|MI|GTX|Antisera, Fluorescent, All Groups, Streptococcus Spp.|1||N|N||866.3740|4|||||N|N
MI|MI|GTY|Antigens, All Groups, Streptococcus Spp.|1||N|N||866.3740|4|||||N|N
MI|MI|GTZ|Antisera, All Groups, Streptococcus Spp.|1||N|N||866.3740|4|||||N|N
MI|MI|GWB|Antisera, Fluorescent, All Types, Streptococcus Pneumoniae|1||N|N||866.3740|4|||||N|N
MI|MI|GWC|Antisera, All Types, Streptococcus Pneumoniae|1||N|N||866.3740|4|||||N|N
MI|MI|GWD|Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp|2||N|N||866.3220|4|||||N|N
MI|MI|JRW|Antisera, Fluorescent, B. Parapertussis|1||N|N||866.3065|4|||||N|N
MI|MI|JRY|Antiserum, Fluorescent, Epstein-Barr Virus|1||N|Y||866.3235|1|||||N|N
MI|MI|JRZ|Media, Culture, Amino Acid Assay|1||N|N||866.2350|4|||||N|N
MI|MI|JSA|Culture Media, Antibiotic Assay|1||N|N||866.2350|4|||||N|N
MI|MI|JSB|Culture Media, Vitamin Assay|1||N|N||866.2350|4|||||N|N
MI|MI|JSC|Culture Media, General Nutrient Broth|1||N|N||866.2350|4|||||N|N
MI|MI|JSD|Culture Media, Selective Broth|1||N|N||866.2360|4|||||N|N
MI|MI|JSE|Culture Media, Multiple Biochemical Test|1||N|N||866.2320|4|||||N|N
MI|MI|JSF|Culture Media, Single Biochemical Test|1||N|N||866.2320|4|||||N|N
MI|MI|JSG|Culture Media, Non-Selective And Non-Differential|1||N|N||866.2300|4|||||N|N
MI|MI|JSH|Culture Media, Non-Selective And Differential|1||N|N||866.2320|4|||||N|N
MI|MI|JSI|Culture Media, Selective And Differential|1||N|N||866.2360|4|||||N|N
MI|MI|JSJ|Culture Media, Selective And Non-Differential|1||N|N||866.2360|4|||||N|N
MI|MI|JSK|Supplement, Culture Media|1||N|N||866.2450|4|||||N|N
MI|MI|JSL|Culture Media, Anaerobic Transport|1||N|Y||866.2390|1|||||N|N
MI|MI|JSM|Culture Media, Non-Propagating Transport|1||N|Y||866.2390|1|||||N|N
MI|MI|JSN|Culture Media, Propagating Transport|1||N|Y||866.2390|1|||||N|N
MI|MI|JSO|Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar|2||N|N||866.1700|1|||||N|N
MI|MI|JSP|Kit, Anaerobic Identification|1||N|N||866.2660|4|||||N|N
MI|MI|JSR|Kit, Identification, Dermatophyte|1||N|N||866.2660|4|||||N|N
MI|MI|JSS|Kit, Identification, Enterobacteriaceae|1||N|N||866.2660|4|||||N|N
MI|MI|JST|Kit, Fastidious Organisms|1||N|N||866.2660|4|||||N|N
MI|MI|JSW|Kit, Identification, Glucose Nonfermenter|1||N|N||866.2660|4|||||N|N
MI|MI|JSX|Kit, Identification, Neisseria Gonorrhoeae|1||N|N||866.2660|4|||||N|N
MI|MI|JSY|Kit, Identification, Mycobacteria|1||N|N||866.2660|4|||||N|N
MI|MI|JSZ|Kit, Identification, Pseudomonas|1||N|N||866.2660|4|||||N|N
MI|MI|JTA|Monitor, Microbial Growth|1||N|N||866.2560|4|||||N|N
MI|MI|JTB|Device, Media Dispensing/Stacking|1||Y|N||866.2440|4|||||N|N
MI|MI|JTC|Device, Microtiter Diluting/Dispensing|1||N|N||866.2500|4|||||N|N
MI|MI|JTL|Plasma, Coagulase, Human, Horse And Rabbit|1||N|N||866.2160|4|||||N|N
MI|MI|JTM|Anaerobic Box Glove|1||Y|N||866.2120|4|||||N|N
MI|MI|JTN|Susceptibility Test Discs, Antimicrobial|2||N|Y||866.1620|1|||||N|N
MI|MI|JTO|Discs, Strips And Reagents, Microorganism Differentiation|1||N|N||866.2660|4|||||N|N
MI|MI|JTQ|Bath, Incubators/Water, All|1||Y|N||866.2540|4|||||N|N
MI|MI|JTR|Kit, Quality Control For Culture Media|1||N|N||866.2480|4|||||N|N
MI|MI|JTT|Susceptibility Test Powders, Antimicrobial|2||N|Y||866.1640|1|||||N|N
MI|MI|JTW|System, Transport, Aerobic|1||N|Y||866.2900|1|||||N|N
MI|MI|JTX|Transport Systems, Anaerobic|1||N|Y||866.2900|1|||||N|N
MI|MI|JTY|Culture Media, For Isolation Of Pathogenic Neisseria|2||N|N||866.2410|1|||||N|N
MI|MI|JTZ|Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth|2||N|P||866.1700|1|||||N|N
MI|MI|JWK|Antigen, Positive Control, Cryptococcus Neoformans|2||N|N||866.3165|4|||||N|N
MI|MI|JWL|Antigen, Treponema Pallidum For Fta-Abs Test|2||N|P||866.3830|1|||||N|N
MI|MI|JWT|Antigen, Cf, Aspergillus Spp.|1||N|N||866.3040|4|||||N|N
MI|MI|JWW|Antigen, Cf, B. Dermatitidis|2||N|N||866.3060|4|||||N|N
MI|MI|JWX|Kit, Screening, Staphylococcus Aureus|1||N|N||866.2660|4|||||N|N
MI|MI|JWY|Manual Antimicrobial Susceptibility Test Systems|2||N|Y||866.1640|1|||||N|N
MI|MI|JWZ|Kit, Screening, Trichomonas|1||N|N||866.2660|4|||||N|N
MI|MI|JXA|Kit, Screening, Urine|1||N|N||866.2660|4|||||N|N
MI|MI|JXB|Kit, Identification, Yeast|1||N|N||866.2660|4|||||N|N
MI|MI|JXC|Kit, Screening, Yeast|1||N|N||866.2660|4|||||N|N
MI|MI|KFG|Antiserum, Positive Control, Aspergillus Spp.|1||N|N||866.3040|4|||||N|N
MI|MI|KFH|Antiserum, Positive Control, Blastomyces Dermatitidis|2||N|N||866.3060|4|||||N|N
MI|MI|KFI|Strip, Virulence, Corynebacterium Diphtheriae|1||N|N||866.3140|4|||||N|N
MI|MI|KHW|Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.|2||N|N||866.3220|4|||||N|N
MI|MI|KLH|Antisera, C. Acnes|1||N|N||866.3140|4|||||N|N
MI|MI|KZB|Automated Colony Counter|1||N|N||866.2170|4|||||N|N
MI|MI|KZC|Manual Colony Counter|1||Y|N||866.2180|4|||||N|N
MI|MI|KZI|Culture Media, Enriched|1||N|N||866.2330|4|||||N|N
MI|MI|KZJ|Device, Gas Generating|1||N|N||866.2580|4|||||N|N
MI|MI|KZK|Reader, Zone, Automated|1||N|Y||866.2850|1|||||N|N
MI|MI|LFX|Enzyme Linked Immunoabsorbent Assay, Rubella|2||N|P||866.3510|1|||||N|N
MI|MI|LFY|Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster|2||N|P||866.3900|1|||||N|N
MI|MI|LFZ|Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus|2||N|P||866.3175|1|||||N|N
MI|MI|LGA|Device, Oxidase Test For Gonorrhea|3||N|N||866.2420|2|||||N|N
MI|MI|LGB|Gonococcal Antibody Tests|3||N|N||866.3290|2|||||N|N
MI|MI|LGC|Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific|2||N|N||866.3305|1|||||N|N
MI|MI|LGD|Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii|2||N|P||866.3780|1|||||N|N
MI|MI|LHJ|Staphylococcus Aureus Protein A Insoluble|1||N|N||866.3700|4|||||N|N
MI|MI|LHK|Antigen, Id, Candida Albicans|2||N|N||866.3165|4|||||N|N
MI|MI|LHL|Reagents, Antibody, Legionella, Direct & Indirect Fluorescent|2||N|N||866.3300|4|||||N|N
MI|MI|LHT|Staphylococcus Aureus Somatic Antigens|1||N|N||866.3700|4|||||N|N
MI|MI|LHW|Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment|1||N|N||866.3720|4|||||N|N
MI|MI|LIA|Antigens, All Groups, Shigella Spp.|2||N|N||866.3660|4|||||N|N
MI|MI|LIB|Device, General Purpose, Microbiology, Diagnostic|1||N|N||866.2660|4|||||N|N
MI|MI|LIC|Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae|2||N|P||866.3390|1|||||N|N
MI|MI|LIE|Reagent/Device, Inoculum Calibration|2||N|Y||866.1640|1|||||N|N
MI|MI|LIN|Antisera, Conjugated Fluorescent, Cytomegalovirus|2||N|P||866.3175|1|||||N|N
MI|MI|LIO|Device, Specimen Collection|1||N|Y||866.2900|1|||||N|N
MI|MI|LIP|Enzyme Linked Immunoabsorption Assay, Treponema Pallidum|2||N|N||866.3830|1|||||N|N
MI|MI|LIQ|Enzyme Linked Immunoabsorbent Assay, Rotavirus|1||N|N||866.3405|4|||||N|N
MI|MI|LIR|Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae|2||N|P||866.3390|1|||||N|N
MI|MI|LJB|Enzyme Linked Immunoabsorbent Assay, Rubeola Igg|1||N|N||866.3520|4|The qualitative detection of measles specific IgG antibodies in serum or plasma.|IVD reagent kit|antigens and antisera used for the detection of measles antibodies|Not applicable in vitro use|N|N
MI|MI|LJC|Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)|1||N|Y||866.3120|1|||||N|N
MI|MI|LJF|Device, Antimicrobial Drug Removal|1||N|N||866.2560|4|||||N|N
MI|MI|LJG|Quality Control Slides|1||N|N||866.2660|4|||||N|N
MI|MI|LJK|Antisera, If, Toxoplasma Gondii|2||N|P||866.3780|1|||||N|N
MI|MI|LJN|Antibody Igm, If, Epstein-Barr Virus|1||N|Y||866.3235|1|||||N|N
MI|MI|LJO|Antigen, Iha, Cytomegalovirus|2||N|P||866.3175|1|||||N|N
MI|MI|LJP|Antiserum, Fluorescent, Chlamydia Trachomatis|1||N|Y||866.3120|1|||||N|N
MI|MI|LJY|Enzyme Linked Immunoabsorbent Assay, Mumps Virus|1||N|N||866.3380|4|||||N|N
MI|MI|LJZ|Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.|1||N|N||866.3375|4|||||N|N
MI|MI|LKA|Culture Media, Antimicrobial Susceptibility Test|2||N|P||866.1700|1|||||N|N
MI|MI|LKC|Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus|2||N|N||866.3305|1|||||N|N
MI|MI|LKH|Antisera, Immunoperoxidase, Chlamydia Spp.|1||N|Y||866.3120|1|||||N|N
MI|MI|LKI|Antisera, Fluorescent, Chlamydia Spp.|1||N|Y||866.3120|1|||||N|N
MI|MI|LKQ|Antibody Igm,If, Cytomegalovirus Virus|2||N|P||866.3175|1|||||N|N
MI|MI|LKS|Device, Parasite Concentration|1||N|Y||866.2900|1|||||N|N
MI|MI|LKT|Respiratory Syncytial Virus, Antigen, Antibody, Ifa|1||N|N||866.3480|4|||||N|N
MI|MI|LLA|Direct Agglutination Test, Toxoplasma Gondii|2||N|P||866.3780|1|||||N|N
MI|MI|LLH|Reagents, Clostridium Difficile Toxin|1||N|N||866.2660|4|||||N|N
MI|MI|LLM|Test, Antigen, Nuclear, Epstein-Barr Virus|1||N|Y||866.3235|1|||||N|N
MI|MI|LOL|Hepatitis A Test (Antibody And Igm Antibody)|2||N|N||866.3310|1|||||N|N
MI|MI|LON|System, Test, Automated, Antimicrobial Susceptibility, Short Incubation|2||N|N||866.1645|1|||||N|N
MI|MI|LOO|Reagent, Leishmanii Serological|1||N|N||866.3870|1|||||N|N
MI|MI|LOP|Solution, Antimicrobial|2||N|Y||866.1640|1|||||N|N
MI|MI|LQF|Dna-Reagents, Mycobacterium Spp.|1||N|Y||866.3370|1|||||N|N
MI|MI|LQG|Dna-Reagents, Mycoplasma Spp.|1||N|N||866.3375|4|||||N|N
MI|MI|LQH|Dna-Reagents, Legionella|2||N|N||866.3300|4|||||N|N
MI|MI|LQL|Gram Positive Identification Panel|1||N|N||866.2660|4|||||N|N
MI|MI|LQM|Gram Negative Identification Panel|1||N|N||866.2660|4|||||N|N
MI|MI|LQN|Latex Agglutination Assay, Rubella|2||N|P||866.3510|1|||||N|N
MI|MI|LQO|Dna-Reagents, Campylobacter Spp.|1||N|Y||866.3110|1|||||N|N
MI|MI|LQP|Campylobacter Spp.|1||N|Y||866.3110|1|||||N|N
MI|MI|LRF|Candida Spp., Direct Antigen, Id|2||N|N||866.3165|4|||||N|N
MI|MI|LRG|Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems|2||N|Y||866.1640|1|||||N|N
MI|MI|LRH|Instrument For Auto Reader Of Overnight Microorganism Identification System|1||N|N||866.2660|4|||||N|N
MI|MI|LSC|Neisseria Controls|1||N|N||866.2660|4|||||N|N
MI|MI|LSD|Rubella, Other Assays|2||N|P||866.3510|1|||||N|N
MI|MI|LSE|Epstein-Barr Virus, Other|1||N|Y||866.3235|1|||||N|N
MI|MI|LSF|Dna-Reagents, Epstein-Barr Virus|1||N|Y||866.3235|1|||||N|N
MI|MI|LSG|Candida Species, Antibody Detection|2||N|N||866.3165|4|||||N|N
MI|MI|LSH|Antigen, Blastomyces Dermatitidis, Other|2||N|N||866.3060|4|||||N|N
MI|MI|LSI|Antiserum, Blastomyces Dermatitidis, Other|2||N|N||866.3060|4|||||N|N
MI|MI|LSJ|Antigen, Rubella, Other|2||N|P||866.3510|1|||||N|N
MI|MI|LSK|Dna-Reagents, Chlamydia|1||N|Y||866.3120|1|||||N|N
MI|MI|LSL|Dna-Reagents, Neisseria|2||N|N||866.3390|1|||||N|N
MI|MI|LSM|Dna-Reagents, Salmonella Spp.|2||N|N||866.3550|4|||||N|N
MI|MI|LSN|Dna-Reagents, Shigella Spp.|2||N|N||866.3660|4|||||N|N
MI|MI|LSO|Dna-Reagents, Cytomegalovirus|2||N|N||866.3175|1|||||N|N
MI|MI|LSQ|Reagent, Rickettsia Serological|1||N|N||866.3500|4|||||N|N
MI|MI|LSR|Reagent, Borrelia Serological Reagent|2||N|N||866.3830|1|||||N|N
MI|MI|LTS|Test Reagents, Neisseria Gonorrhoeae Biochemical|1||N|N||866.2660|4|||||N|N
MI|MI|LTT|Panels, Test, Susceptibility, Antimicrobial|2||N|Y||866.1640|1|||||N|N
MI|MI|LTW|Susceptibility Test Cards, Antimicrobial|2||N|Y||866.1640|1|||||N|N
MI|MI|LTX|Discs, Elution|2||N|Y||866.1620|1|||||N|N
MI|MI|LYF|Pneumocystis Carinii|2||N|N||866.3780|1|||||N|N
MI|MI|LYR|Helicobacter Pylori|1||N|Y||866.3110|1|||||N|N
MI|MI|MBT|Dna-Probe, Reagent, Histoplasma Capsulatum|2||N|N||866.3320|4|||||N|N
MI|MI|MCB|Antigen, C. Difficile|1||N|N||866.2660|4|||||N|N
MI|MI|MCC|Dna-Probe, Haemophilus Spp.|2||N|N||866.3300|4|||||N|N
MI|MI|MCD|Antigen, Ebv, Capsid|1||N|Y||866.3235|1|||||N|N
MI|MI|MCE|Respiratory Syncytial Virus - Elisa|1||N|N||866.3480|4|||||N|N
MI|MI|MCG|Dna-Probe, Agent, Listeria|1||N|N||866.3355|4|||||N|N
MI|MI|MCS|Dna-Probe, Staphylococcus Aureus|1||N|N||866.3700|4|||||N|N
MI|MI|MCT|Dna-Probe, Strep Pneumoniae|1||N|N||866.3740|4|||||N|N
MI|MI|MDB|System, Blood Culturing|1||N|Y||866.2560|1|||||N|N
MI|MI|MDC|Dna-Probe - Blastomyces Dermatitidis|2||N|N||866.3060|4|||||N|N
MI|MI|MDE|Dna-Probe, Reagents, Cryptococcal|2||N|N||866.3165|4|||||N|N
MI|MI|MDF|Dna-Probe, Reagents, Coccidioides Immitis|2||N|N||866.3135|4|||||N|N
MI|MI|MDJ|Reagents, Cysticercosis|1||N|N||866.3200|4|||||N|N
MI|MI|MDK|Dna-Probe, Reagents, Streptococcal|1||N|N||866.3740|4|||||N|N
MI|MI|MDT|Elisa, Trichinella Spiralis|1||N|N||866.3850|4|||||N|N
MI|MI|MDU|Antigen, Elisa, Cryptococcus|2||N|N||866.3165|4|||||N|N
MI|MI|MGM|C. Trachomatis (Chlamydia Group)|1||N|Y||866.3120|1|||||N|N
MI|MI|MHI|Giardia Spp.|2||N|N||866.3220|4|||||N|N
MI|MI|MHJ|Cryptosporidium Spp.|2||N|N||866.3220|4|||||N|N
MI|MI|MIU|Enzyme Linked Immunosorbent Assay, T. Cruzi|1||N|Y||866.3870|1|||||N|N
MI|MI|MIV|Immunofluorescent Assay, T. Cruzi|1||N|Y||866.3870|1|||||N|N
MI|MI|MIY|Enzyme Linked Immunosorbent Assay, Coccidioides Immitis|2||N|N||866.3135|4|||||N|N
MI|MI|MIZ|Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum|2||N|N||866.3320|4|||||N|N
MI|MI|MJA|Susceptibility Test Powders, Antimycobacterial|2||N|N||866.1640|1|||||N|N
MI|MI|MJD|Culture Media, Antimycobacteria, Susceptibility Test|2||N|N||866.1700|1|||||N|N
MI|MI|MJE|Culture Media, Antifungal, Susceptibility Test|2||N|P||866.1700|1|||||N|N
MI|MI|MJH|Legionella, Spp., Elisa|2||N|N||866.3300|4|||||N|N
MI|MI|MJK|Dna Probe, Trichomonas Vaginalis|1||N|N||866.2660|4|||||N|N
MI|MI|MJL|Eia, Blastomyces Dermatitidis|2||N|N||866.3060|4|||||N|N
MI|MI|MJM|Dna Probe, Gardnerella Vaginalis|1||N|N||866.2660|4|||||N|N
MI|MI|MKZ|Dna Probe, Nucleic Acid Amplification, Chlamydia|1||N|Y||866.3120|1|||||N|N
MI|MI|MLA|Dna Probe, Yeast|1||N|N||866.2660|4|||||N|N
MI|MI|MSQ|Test, Urea (Breath Or Blood)|1||N|Y||866.3110|1|||||N|N
MI|MI|MWA|System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex|2||N|N||866.3372|1|intended to detect Mycobacterium tuberculosis complex nucleic acids extracted from human respiratory specimens. These devices are non-multiplexed and  intended to be used as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.||||N|N
MI|MI|MXJ|Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1|2||N|N||866.3305|1|||||N|N
MI|MI|MYF|Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2|2||N|N||866.3305|1|||||N|N
MI|MI|MYI|System,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies|2||N|N||866.1640|1|||||N|N
MI|MI|NDZ|Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis|1||N|Y||866.3370|1|||||N|N
MI|MI|NGS|Assay, Endotoxin Activity, Chemiluminescent|2||N|N||866.3210|1|||||N|N
MI|MI|NGZ|Susceptibility Test Plate, Antifungal|2||N|N||866.1640|1|The device is an in vitro diagnostic device intended for use in determining quantitative susceptibility of  Candida species to various antifungal agents diluted in varying concentration in a microtiter plate format.||||N|N
MI|MI|NHT|Assay, Nucleic Acid Amplification, Bacillus Anthracis|2||N|N||866.2660|1|An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.||||N|N
MI|MI|NHY|Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus|1||N|N||866.3480|1|These reagents are nucleic acid primers and probes for the amplification and identification of Respiratory Syncytial virus directly from clinical specimens.  The identification aids in the diagnosis of influenza and provides epidemiological information on this disease.  This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera.||||N|N
MI|MI|NHZ|Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus|1||N|N||866.3400|1|These reagents are nucleic acid primers and probes for the amplification and identification of Parainfluenza virus directly from clinical specimens.  The identification aids in the diagnosis of influenza and provides epidemiological information on this disease.  This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera.||||N|N
MI|MI|NIA|Assay, Direct, Nucleic Acid Amplification, Influenza Virus|1||N|N||866.3330|1|These reagents are nucleic acid primers and probes for the amplification and identification of Influenza virus directly from clinical specimens.  The identification aids in the diagnosis of influenza and provides epidemiological information on this disease.  This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera.||||N|N
MI|MI|NIJ|System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species|2||N|N||866.1640|1|The in vitro device is intended to detect the presence of the vanA and vanB genes in isolated colonies of Enterococcus spp.  as a marker for vancomycin resistance using DNA probe technology||||N|N
MI|MI|NJO|System, Mycolic Acid Analysis, Mycobacterium Tuberculosis|1||N|N||866.3370|1|A mycolic acids analysis system is intended to aid in the identification of M. tuberculosis and differentiation from other mycobacteria species through the analysis of mycolic acids derived from cultured bacterial samples, using high performance liquid chromatography (HPLC) performed and pattern recognition software.  The system is used, along with other identification methods, to identify mycobacteria that have been isolated from clinical specimens by traditional culturing techniques.  Following observation of growth on the solid medium, identification of the mycobacterial isolate is done with extraction and analysis of mycolic acids.  Results should be interpreted in conjunction with other laboratory observations and procedures.||||N|N
MI|MI|NJR|Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test|1||N|N||866.3740|4|A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of group b streptococci from pre-partum and intra-partum women to establish colonization status.||||N|N
MI|MI|NOM|Antigen, Galactomannan, Aspergillus Spp.|1||N|N||866.3040|1|The Platelia Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in human serum.    It is a test which, when used in conjunction with other diagnostic procedures such as microbiological culture, histological examination of biopsy samples and radiographic evidence, can be used as an aid in the diagnosis of Invasive Aspergillosis.||||N|N
MI|MI|NOP|Elisa, Antibody, West Nile Virus|2||N|N||866.3940|1|The West Nile Virus ELISA is intended for the detection of IgG and IgM antibodies to West Nile Virus. Specimens may be serum or cerebral spinal fluid from symptomatic patients.||||N|N
MI|MI|NQX|System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen|2||N|N||866.1640|1|A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.||||N|N
MI|MI|NQZ|Antigen, Invasive Fungal Pathogens|2||N|N||866.3050|1|Invasive fungal pathogen assays are devices that consist of antigens, antisera, or proteases used in serological assays for the presumptive diagnosis of fungal infection in serum or plasma.  The assay is indicated for use in patients with symptoms of, or medical conditions predisposing the patient to invasive fungal infection.  The device can be used as an aid in the diagnosis of deep seated mycoses and fungemias.  A positive result does not indicate which class of fungi may be causing infection. The assays should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.||||N|N
MI|MI|NTM|Antigen, Inflammatory Response Marker, Sepsis|2||N|N||866.3210|1|An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma.||||N|N
MI|MI|NXD|Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna|2||N|N||866.3332|1|Novel influenza a virus reagents are used in nucleic acid amplification tests to directly detect and differentiate novel influenza a virus specific rna gene segments in human respiratory specimens or viral cultures. Detection and differentiation of specific rna gene segments aids in the diagnosis of influenza caused by novel influenza a viruses in patients with clinical and epidemiological risk of infection with these viruses. They also aid in the presumptive identification of specific novel influenza a viruses and provide epidemiological information on influenza. These reagents are primers and probes, along with a specific novel influenza virus control.|OIVD|Direct nucleic acid amplification|specific RNA segment|N|N
MI|MI|NXX|Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus|1||N|N||866.3700|4|The s. Aureus pna fish is a qualitative nucleic acid hybridization assay intended for presumptive identification of staphylococcus aureus from blood cultures with gram-positive cocci in clusters (gpcc).  This device is not exempt per 21 cfr part 866.9(c)(6).|Kit box containing 1.5 ml Fixation Solution,  S. aureus-specific PNA probe in hybridization solution, Wash Solution and Mounting Medium. One-well microscope slides, fluorescent microscope equipped with a Dual Band Filter, and Control Slides are required and are available from the manufacturer.|Fluorescent In Situ Hybridization using protein nucleic acid (PNA) probes.|Systemic blood culture|N|N
MI|MI|NZS|Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast|1||N|N||866.2660|4|Indicated as a qualitative nucleic acid hybridization assay intended for identification of candida albicans from blood cultures with yeast.|Kit contains 3 ml bottle fixation solution, 1.5 ml bottle fluorescein labeled PNA probe in hybridization solution, 50 ml concentrated wash solution. One well, Teflon coated microscope slides available from manufacturer.|PNA probe is added to a fixed smear prepared from liquid blood culture media with yeast. Hybridization is performed during a 90 minute incubation at 55 degrees C in an incubator or slide warmer. The slide is examined by fluorescent microscopy within 2 hrs. C. albicans is identified as bright green fluorescent yeast cells, whereas non C.albicans will not fluoresce.|systemic blood cultures|N|N
MI|MI|OAH|Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis|1||N|N||866.3740|4|E. Faecalis pna fish is a qualitative nucleic acid hybridization assay intended for the identification of enterococcus faecalis and other enterococci (oe) from blood cultures showing Gram-positive cocci in pairs and chains.|A mixture of fluoroscein-labeled E. faecalis specific PNA probe and a rhodamine-labeled PNA probe specific for Enterococcus species is added to a fixed smear prepared from a positive blood culture showing gram positive cocci. Hybridization is followed by a wash step. The smear is mounted and examined by fluorescent microscopy.|E. faecalis PNA FISH is a multicolor fluorescence in situ hybridization method using protein nucleic acid probes hybridizing to E. faecalis-specific ribosomal RNA sequences and to ribosomal sequences of other Enterococcus species.|Smears made from positive blood cultures showing gram positive cocci.|N|N
MI|MI|OAI|Assay, Enterovirus Nucleic Acid|2||N|N||866.3225|1|Consists of primers, probes, enzymes and controls for the amplification and detection of enterovirus RNA in cerebrospinal fluid (CSF) from individuals who have signs and symptoms consistent with meningitis or meningoencephalitis.  The detection of enterovirus RNA, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of viral meningitis caused by enterovirus.|N/A|Nucleic acid amplification assay system, self-contained cartridge with dedicated instrument.|Enterovirus (EV) RNA (enterovirus genome 5 prime untranslated region (UTR) between nucleotides 452 and 596)|N|N
MI|MI|OAX|Plasmodium Spp. Detection Reagents|2||N|N||866.3402|1|For the detection of plasmodium spp. Antigens in venous or capillary whole blood.  To aid in the diagnosis of human malaria infections and/or to aid in the differential diagnosis of plasmodium falciparum infections from other less virulent plasmodium species.|In Vitro diagnostic kit|In vitro diagnostic immunochromatographic membrane assays or lateral flow assays that uses  antibodies to detect specific antigens.|Plasmodium spp. antigens in whole blood|N|N
MI|MI|OCC|Respiratory Virus Panel Nucleic Acid Assay System|2||N|N||866.3980|1|A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture.  The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings.  The device is intended for detection and identification of a combination of the following viruses:  Influenza A and Influenza B, Influenza A subtype H1 and Influenza A subtype H3, Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus.|A qualitative in vitro diagnostic assay intended to simultaneously detect, identify, and/or differentiate multiple respiratory virus nucleic acid extracted from human respiratory specimens or viral cultures.  Detection and differentiation of specific virus RNA or DNA aids in the diagnosis of respiratory infections in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of infection with these viruses.|A qualitative in vitro diagnostic assay intended to simultaneously detect, identify, and/or differentiate multiple respiratory virus nucleic acid extracted from human respiratory specimens or viral cultures.  Detection and differentiation of specific virus RNA or DNA aids in the diagnosis of respiratory infections in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of infection with these viruses.|In vitro diagnostic device|N|N
MI|MI|OEH|Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit|2||N|N||866.3280|1|To aid in the diagnosis of individuals presenting with signs and symptoms of pneumonic or typhoidal tularemia with a qualitative in vitro diagnostic (ivd) detection of target dna sequences of francisella tularensis.|Kit contains 6 vacuum-sealed pouches of freeze-dried PCR reagents, containing 4 vials each, and six pouches containing one tube each of reconstitution buffer and reagent grade water.  Designed to be used on the JBAIDS instrument (K051713).|Real-time polymerase chain reaction (PCR)amplification and detection system.|Matrices: whole blood, sputum, colony and blood cultures.|N|N
MI|MI|OEM|Human Metapneumovirus (Hmpv) Rna Assay System|2||N|N||866.3980|1|A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hmpv) rna extracted from human respiratory specimens or viral cultures. Detection of hmpv rna aids in the diagnosis of respiratory hmpv infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infections.|Human metapneumovirus (hMPV) RNA detection assay systems are devices that consist of reagents and instruments for the detection of hMPV RNA extracted from human respiratory specimens or viral cultures.|A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hMPV) RNA extracted from human respiratory specimens or viral cultures.|in vitro diagnostic assay|N|N
MI|MI|OEP|Influenza A Virus Subtype Differentiation Nucleic Acid Assay|2||N|N||866.3980|1|A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture.  Detection and differentiation of specific subtype rna aids in the diagnosis of influenza caused by influenza a in conjunction with other clinical and laboratory testing in patients suspected of being infected with these viruses.  Also, it aids in the presumptive laboratory identification of influenza a virus subtypes to provide epidemiological information on influenza.|OIVD|Direct nucleic acid detection|Specific RNA segments|N|N
MI|MI|OMG|Antisera, Fluorescent, Human Metapneumovirus|2||N|N||866.3980|1|It is intended for the qualitative detection and identification of human metapneumovirus (hMPV) in direct respiratory specimens or cell culture. The assay detects hMPV antigens by immunofluorescence using antibodies, from patients with signs and symptoms of acute respiratory infection. This assay detects but is not intended to differentiate the four recognized genetic sub-lineages of hMPV.|hMPV DSFA, hMPV DFA|The assay detects hMPV antigens by immunofluorescence using antibodies.|Direct clinical speciemns or cell culture amplified speciemns|N|N
MI|MI|OMI|Multiplex Flow Immunoassay, T.Gondii, Rubella And Cmv.|2||N|N||866.3510|1|The kit is a multiplex immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondii) and Rubella, and  qualitative detection of Cytomegalovirus (CMV) IgG in human serum and/ or plasma.  Indicated as an aid in the determination of serological status to T. gondii, Rubella and CMV. This kit is not intended for use in screening blood or plasma donors.|The device is a fully automated instrument.|The device utilizes multiplex immunofluorescence technology to assess the presence of IgG antibodies for each of the analytes in the panel in a single sample by binding to antigen-coated fluoromagnetic beads with unique fluorescent signatures.|Assay|N|N
MI|MI|OMN|C. Difficile Nucleic Acid Amplification Test Assay|1||N|N||866.2660|4|In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.|kIt containing DNA positive control, DNA internal control, buffer containing deoxyribonucleic acids and magnesium chloride, DNA polymerase, DNA primers and DNA probes|Nucleic acid amplification test|Stool samples|N|N
MI|MI|OMS|Novel Influenza A Virus, A/H5 Ns1 Protein|2||N|N||866.3332|1|Novel influenza A virus reagents are used to directly detect and differentiate novel influenza A virus specific nonstructural protein 1 (NS1) in human respiratory specimens or viral cultures.  Detection and differentiation of specific NS1 protein aids in the diagnosis of influenza caused by novel influenza A viruses in patients with clinical and epidemiological risk of infection with these viruses. They also aid in the presumptive identification of specific novel influenza A viruses and provide epidemiological information on influenza.|OIVD|Immunoassay using PDZ domains in intracellular receptors to capture influenza A/H5 NS1 protein|PDZ ligands (PL) of NS1 protein|N|N
MI|MI|OOU|Parainfluenza Multiplex Nucleic Acid Assay|2||N|N||866.3980|1|A parainfluenza multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of human parainfluenza nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract parainfluenza infections if used in conjunction with other clinical and laboratory findings.|Nucleic Acid Based Assay|Multiplex nucleic acid assay|IVD|N|N
MI|MI|OPL|Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus|2||N|N||866.3510|1|The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to measles virus, mumps virus, Rubella and varicella zoster virus (VZV) in human serum and/ or plasma. The results of this assay are intended to be used as an aid in the assessment of a patient¿s serological status to measles virus, mumps virus, Rubella and VZV. The test is not intended for use in screening blood or plasma donors.|The device is a fully automated instrument|Multiplex flow immunoassay (multiplexed fluromagnetic bead assay)|The device is an in-vitro diagnostic device; none of the body parts will utilize the device or is intended to be affected by the device|N|N
MI|MI|OPM|Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2|2||N|N||866.3510|1|The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to Toxoplasma gondii (T.gondii), Rubella, Cytomegalovirus (CMV) and Herpes Simplex Virus 1 & 2 (HSV 1 and HSV 2) in human serum. The results of this assay are intended to be used as an aid in the assessment of a patient's serological status to Toxoplasma gondii, Rubella, CMV and HSV 1 & 2. The test is not intended for use in screening blood or plasma donors.|Assay|Multiplex flow immunoassay (multiplexed fluromagnetic bead assay)|none|N|N
MI|MI|OQO|Herpes Simplex Virus Nucleic Acid Amplification Assay|2||N|N||866.3305|1|A polymerase chain reaction (pcr)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (hsv) dna using vaginal swab specimens.|Plasma, serum, swab, culture isolates|Polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV) DNA|Systemic|N|N
MI|MI|OQW|2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification|2||N|N||866.3332|1|2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens|Reagent Kit|Nucleic acid amplification or antigen detection assays|The device is an in-vitro diagnostic device; none of the body parts will utilize the device or are intended to be affected by the device|N|N
MI|MI|OSU|Dengue Serological Reagents|2||N|N||866.3945|1|Dengue virus serological reagents are devices that consist of antigens and antisera for the detection of anti-dengue antibodies, individuals that have signs and symptoms consistent with dengue. The detection aids in the clinical laboratory diagnosis of dengue fever or dengue hemorrhagic fever caused by dengue  virus. The device is intended for use in the presumptive diagnosis of patients in conjunction with other clinical and laboratory findings.|Kits|Immunological method/ELISA|Human serum|N|N
MI|MI|OTG|Non-Sars Coronavirus Multiplex Nucleic Acid Assay|2||N|N||866.3980|1|A non-SARS coronavirus multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of coronavirus 229E, coronavirus NL63, coronavirus HKU1 and Coronavirus OC43 nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of human non-SARS coronavirus nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract non-SARS coronavirus infections if used in conjunction with other clinical and laboratory findings.|Nucleic Acid Based Assay|Multiplex nucleic acid assay|IVD|N|N
MI|MI|OUC|Norovirus Serological Reagent|2||N|N||866.3395|1|Norovirus serological reagents are devices that consist of antigens and antisera for the detection of anti-norovirus antibodies or norovirus antigens. The detection aids in the clinical laboratory diagnosis of norovirus infection in individuals with signs and/or symptoms of acute gastroenteritis, or in the determining the etiology of acute gastroenteritis outbreaks.|Laboratory kit.|ELISA-based or immunological based assays.|Human biological specimens.|N|N
MI|MI|OUS|Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood  Culture Test Bt|1||N|N||866.2050|1|The  mrsa/mssa blood  culture test-bt  is a qualitative  ivd test using bacteriophage amplification for the identification of  staphylococcus aureus and the determination of  meca mediated methicillin resistance or methicillin susceptbility  directly  from positive blood cultures  confirmed to have gram positive cocci in clusters (gpcc) or gram positive cocci in singles (gpc) by gram stain.|Kit consisting of plastic capped tubes, pipets, lateral flow cassette and liquid reagents|Bacteriophage amplification|Systemic, blood|N|N
MI|MI|OUZ|Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids|1||N|N||866.3870|1|Detection of  Leishmania species in skin lesions.|In vitro diagnostic kit|Nucleic Acid Amplification assay containing probes and primers|suspected skin ulcer or skin lesion|N|N
MI|MI|OVF|Assay, Direct, Nucleic Acid Amplification, Q Fever|1||N|N||866.3500|1|These reagents are nucleic acid primers and probes intended for the amplification and identification of Coxiella burnetii directly from clinical specimens. The identification aids in the diagnosis of Q Fever and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera or antigens.|A kit that contains reagents and an instrument that measures flourescence.|The Q Fever assay uses a real-time thermocycler. A real-time thermocycler is intended to identify and/or quantify the presence of specific sequences of double stranded DNA, amplified from a biological source and labeled with fluorescently labeled probes or through the use of intercalating dyes and detect using a high-power light-emitting diode (LED). Fluorescence emission is detected through the use of filters on a photodiode. The emission filters are optimized for use with specific fluorescent dyes.|Blood|N|N
MI|MI|OWF|Immunohistochemical Assay, Helicobacter Pylori|1||N|N||866.3110|1|Anti-helicobacter pylori  rabbit monoclonal primary antibody is designed to qualitatively detect the presence of helicobacter pylori in formalin-fixed, paraffin-embedded gastric biopsy tissue via light microscopy. Immunohistochemical staining with this antibody product may aid in the diagnosis of helicobacter pylori infection. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls.  This antibody is intended for in vitro diagnostic (IVD) use|Benchmark series instruments: BenchMark XT and BenchMark ULTRA auto slide stainer; recombinent rabbit monoclonal primary antibody directed against whole Helicobacter pylori organism|Uses immunohistochemical staining methods to qualitatively detect Helicobacter pylori in paraffin-embedded, gastric biopsy tissue|Helicobacter pylori in paraffin-embedded, gastric biopsy tissue|N|N
MI|MI|OYP|Anti-Jcv Antibody Detection Assay|2||N|N||866.3336|1|The anti-jcv antibody detection assay is intended for the detection of antibodies to the john cunningham virus (jcv) in serum or plasma samples from multiple sclerosis (ms) and crohn's disease (cd) patients receiving immunomodulatory  therapies.|Reagent kit.|A serological test for the detection of the presence on anti-JCV specific antibodies in serum or plasma samples by an enzyme linked immunosorbent technology|In-vitro diagnostic test|N|N
MI|MI|OYZ|Group A Streptococcus Nucleic Acid Amplification Assay System|1||N|N||866.3740|1|An in vitro diagnostic test for the detection of Streptococcuc pyogenes (Group A beta hemolytic Streptococcus) in throat swab specimens from symptomatic patients.|May include automated/manual isothermal nucleic acid amplification, polymerase chain reaction, ligase chain reaction, sequence-based amplification|Uses nucleic acid amplification technology to detect Group A Sreptococci|Throat Swab Specimen|N|N
MI|MI|OZA|Test, Urea Adult And Pediatric (Breath),|3||N|N||866.3110|2|Intended for use in the qualitative detection of urease associated with h. Pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of h. Pylori infection in adults and pediatric patients. The test may be used for monitoring treatment if used at 4 weeks following completion of therapy.|Human Breath|System utilizes an Infrared Spectrophotometer|Stomach, esophagogastroduodenoscopy|N|N
MI|MI|OZB|Dengue Nucleic Acid Amplification Assay (Naat)|2||N|N||866.3946|1|A qualitative in vitro diagnostic assay for the detection of dengue  virus serotypes 1, 2, 3 or 4 in serum or plasma specimens collected from human patients with signs and symptoms consistent with dengue (mild or severe).|Dengue nucleic acid amplification and detection reagents including primers and probes, positive controls, and human specimen extraction control|Uses nucleic acid amplification technology for detection of dengue virus target sequences|Human clinical samples e.g., blood serum, plasma|N|N
MI|MI|OZE|Influenza A And Influenza B Multiplex Nucleic Acid Assay|2||N|N||866.3980|1|An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of influenza A and B nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract influenza viral infections if used in conjunction with other clinical and laboratory findings.|Nucleic acid based assay|Multiplex nucleic acid assay|IVD|N|N
MI|MI|OZN|C.Difficile Toxin Gene Amplification Assay|2||N|N||866.3130|1|Amplification assay for the detection of c. Difficile toxin genes from stool specimens of  symptomatic patients.|Not applicable|Uses amplification technology to detect toxin genes of C. difficile|Not applicable|N|N
MI|MI|OZX|Mycoplasma Pneumoniae Dna Assay System|2||N|N||866.3980|1|A qualitative in vitro diagnostic assay intended to detect Mycoplasma pneumoniae DNA extracted from human respiratory specimens. Detection of Mycoplasma pneumoniae DNA aids in the diagnosis of Mycoplasma pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.|Mycoplasma pneumoniae DNA detection assay systems are devices that consist of reagents and instruments for the detection of Mycoplasma pneumoniae DNA extracted from human respiratory specimens.|A qualitative in vitro diagnostic assay intended to detect Mycoplasma pneumoniae DNA extracted from human respiratory specimens.|in vitro diagnostic assay|N|N
MI|MI|OZY|Chlamydophila Pneumoniae Dna Assay System|2||N|N||866.3980|1|A qualitative in vitro diagnostic assay intended to detect Chlamydophila pneumoniae DNA extracted from human respiratory specimens. Detection of Chlamydophila pneumoniae DNA aids in the diagnosis of Chlamydophila pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.|Chlamydophila pneumoniae DNA detection assay systems are devices that consist of reagents and instruments for the detection of Chlamydophila pneumoniae DNA extracted from human respiratory specimens.|A qualitative in vitro diagnostic assay intended to Chlamydophila pneumoniae DNA extracted from human respiratory specimens.|in vitro diagnostic assay|N|N
MI|MI|OZZ|Bordetella Pertussis Dna Assay System|2||N|N||866.3980|1|A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.|Bordetella pertussis DNA detection assay systems are devices that consist of reagents and instruments for the detection of Bordetella pertussis DNA extracted from human respiratory specimens.|A qualitative in vitro diagnostic assay intended to Bordetella pertussis DNA extracted from human respiratory specimens.|in vitro diagnostic assay|N|N
MI|MI|PAM|Gram-Positive Bacteria And Their Resistance Markers|2||N|N||866.3365|1|A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.|blood|Multiplexed DNA hybridization array|Systemic|N|N
MI|MI|PCH|Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System|2||N|N||866.3990|1|A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.|Gastrointestinal pathogen panel multiplex nucleic acid-based assay systems are devices that consist of reagents and instruments for the simultaneous detection and identification of multiple gastrointestinal microbial nucleic acids extracted from human stool specimens.|A qualitative in vitro diagnostic assay intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.|In vitro diagnostic device|N|N
MI|MI|PCI|Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System|2||N|N||866.3990|1|A gastrointestinal bacterial panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal bacterial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal bacterial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.|Gastrointestinal bacterial panel multiplex nucleic acid-based assay systems are devices that consist of reagents and instruments for the simultaneous detection and identification of multiple gastrointestinal bacterial nucleic acids extracted from human stool specimens.|A qualitative in vitro diagnostic assay intended to simultaneously detect and identify multiple gastrointestinal bacterial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal bacterial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.|In vitro diagnostic device|N|N
MI|MI|PCL|Enzyme Linked Immunoabsorbent Assay, Rubeola Igm|1||N|N||866.3520|4|The qualitative detection of measles specific  IgM antibodies in serum or plasma.|IVD reagent kit|antigens and antisera used for the detection of measles antibodies|Not applicable in vitro use|N|N
MI|MI|PEN|Gram-Negative Bacteria And Associated Resistance Markers|2||N|N||866.3365|1|A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.|Reagent kit|Multiplexed nucleic acid-based assay|N/A|N|N
MI|MI|PEO|Fungal Organisms, Nucleic Acid-Based Assay|2||N|N||866.3365|1|A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures.|Reagent Kit|Multiplexed nucleic acid-based assay|N/A|N|N
MI|MI|PEU|System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen|2||N|N||866.3373|1|The [test] is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than 3 days of therapy. This [test] is intended as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.|in vitro diagnostic|Nested real-time PCR.  The [test] must be used in conjunction with mycobacterial culture to address the risk of false negative results and to recover the organisms for further characterization and drug susceptibility testing.    The [test] should only be performed in laboratories that follow safety practices according to the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories publication (http://www.cdc.gov/biosafety/publications/bmbl5/index.htm) and applicable state or local regulations.|Sputum|N|N
MI|MI|PEX|System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates|2||N|N||866.3361|1|A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.|In vitro diagnostic device|Matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) mass spectrometry|Identification of microorganisms cultured from human specimens|N|N
MI|MI|PGH|Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel|2||N|N||866.3307|1|Intended for the qualitative detection and differentiation of HSV-1 and HSV-2 in cerebrospinal fluid (CSF) from patients with signs and symptoms of Herpes Simplex Virus (HSV) central nervous system (CNS) infection.  This test is an aid in the diagnosis of HSV-1 and HSV-2 CNS infections in conjunction with other clinical and laboratory findings. Negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.|Reagent Assay Kit and Instrument|Real-time Polymerase Chain Reaction Assay|Not Applicable, the device is an In vitro diagnostic device|N|Y
MI|MI|PGI|Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples|2||N|N||866.3309|1|For the qualitative detection and differentiation of VZV, HSV1, HSV2- DNA in cutaneous and mucocutaneous lesion samples from symptomatic patients. The assay is not intended for use with cerebral spinal fluid.|Reagent assay kit and instrument|Polymerase chain reaction|Not Applicable. In vitro diagnostic device|N|N
MI|MI|PGX|Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System|2||N|N||866.2680|1|An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients.|May include automated/manual isothermal nucleic acid amplification, polymerase chain reaction, ligase chain reaction, sequence-based amplification|Uses nucleic acid amplification technology to detect Groups A, C and G Sreptococci|Throat Swab Specimen|N|N
MI|MI|PIQ|Reagents For Detection Of Norovirus Nucleic Acid|2||N|N||866.3990|1|Qualitative in vitro diagnostic test for the rapid detection and differentiation of norovirus genogroup I and genogroup II from specimens e.g., stool collected from individuals with symptoms of acute gastroenteritis.|The device/system consists of an instrument, personal computer, and preloaded software for running the tests and viewing the results.|Instrument Systems automate and integrate sample preparation, nucleic acid  extraction and amplification, and detection of the target sequences in simple or complex samples using reverse transcriptase PCR (RT-PCR) and real-time PCR assays.|Noninvasive|N|N
MI|MI|PIT|Leishmania Spp. Antigen Detection Assay|1||N|N||866.3870|1|An in vitro diagnostic test for the detection of Leishmania spp. antigens to aid in the diagnosis of Leishmania spp. infection.|In vitro diagnostic kit|May include immunochromatographic assays,  enzyme linked immunoassays, or other in vitro diagnostic methods to detect antigens from Leishmania spp.|Clinical specimens from patients suspected of infection with Leishmania spp.|N|N
MI|MI|PLO|Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System|2||N|N||866.3970|1|A meningitis/encephalitis pathogen multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the direct detection and identification of microbial-associated nucleic acids in cerebrospinal fluid. The test is indicated for individuals with signs and symptoms of meningitis or encephalitis and aids in diagnosis of agents of meningitis or encephalitis when used in conjunction with clinical and other laboratory findings.|Meningitis/encephalitis pathogen multiplex nucleic acid detection systems are in vitro devices that consist of reagents and associated instrumentation for detection and identification of microbial nucleic acids in cerebrospinal fluid specimens.|A qualitative in vitro diagnostic assay that detects and identifies microbial-associated nucleic acids in cerebrospinal fluid specimens.|In vitro diagnostic device|N|N
MI||LOM|Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)|3||N|N|||2|||||N|N
MI||LQI|Hepatitis Delta Serological Reagents|3||N|N|||2|||||N|N
MI||MAQ|Kit, Dna Detection, Human Papillomavirus|3||N|N|||2|||||N|N
MI||MHR|Test, Anti-Tumor Cell Susceptibility|3||N|N|||2|||||N|N
MI||MKT|Hepatitis Viral B Dna Detection |3||N|N|||2|Nucleic acid assay for detection of Hepatitis B Virus (HBV) DNA is an in vitro nucleic acid assay for detection and quantitation of HBV DNA in human serum or plasma. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment.  The test results must be interpreted within the context of all relevant clinical and laboratory findings.||||N|N
MI||MYL|Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg|3||N|N|||2|||||N|N
MI||MYM|Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm|3||N|N|||2|||||N|N
MI||MZO|Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus|3||N|N|||2|||||N|N
MI||MZP|Assay,Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus|3||N|N|||2|||||N|N
MI||NCD|Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis|3||N|N|||2|||||N|N
MI||NPO|Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody|U|1|N|N|||1|A serological reagent to distinguish b. Anthracis culture growth  from other bacillus spp. Growth||||N|N
MI||NRL|Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis|U|1|N|N|||1|The elisa assay for antibodies to b. Anthracis is used to detect an immunological response to proteins secreted by b. Anthracis; As an aid in the laboratory diagnosis of anthrax.||||N|N
MI||NVQ|Bacteriophage And Controls, B. Anthracis Lysis|U|1|N|N|||1|A gamma phage lysis assay intended for the identification of bacillus anthracis from non-hemolytic, aerobic gram positive colonies isolated from sheep blood agar.  To aid in the laboratory identification of bacillus anthracis culture growth by lysis with a specific bacteriophage.|Cultured isolates|Bacteriophage, culture|Systemic|N|N
MI||NWY|Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies|N|3|N|N|||3|Intended for the detection of IgM and IgG antibodies to dengue virus in human serum, plasma or whole blood.|In-vitro diagnositc test|In-vitro diagnostic test|In-vitro diagnostic test|N|N
MI||NWZ|Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids|U|1|N|N|||1|aid in the identification of Bacillus Anthracis|25 x 0.2 mm capillary column (0.33-film thickness of 5% diphenyl-95%-dimethyl siloxane), an oven with 170-270aC increase range during analysis, an autoinjector, MIDI Sherlock Microbial Identification System software that includes the BTR library, and a calibration standard|gas chromatography and pattern recognition|trypticase soy agar (with 5% sheep blood) bacterial cultures of any specimen type from the human body|N|N
MI||OBF|Assay, Genotyping, Hepatitis C Virus|N|3|N|N|||3|Export only|Export Only|In vitro diagnostic device for qualitative detection and classification of 8 clinically relevant Hepatitis C Virus RNA genotypes|Export Only|N|N
MI||OIH|Yersinia Spp. Reagents|U|1|N|N|||1|Yersinia spp. reagents are devices that consist of Serological Reagents and Nucleic Acid Amplification Reagents to differentiate Yersinia spp. and presumptively identify Yersinia pestis (Y. pestis) from cultured isolates or clinical specimens.  They are indicated for use as an aid in the laboratory of diagnosis of plague.|Kit includes primers, probes, enzymes and specific controls for amplification and are designed for use with specific instrument systems.|Nucleic Acid Amplification Reagents|Systemic, Whole blood, sputum,|N|N
MI||OJN|Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test|3||N|N|||2|For the detection of effector T cells that respond to stimulation by Mycobacterium tuberculosis antigens ESAT-6 and CFP-10 and indicated for use as an aid in the diagnosis of M. tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations.|In vitro diagnostic kit|Enzyme-linked immunospot assay|Peripheral Blood|N|N
MI||OJO|Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria|N|3|N|N|||3|Enzyme linked immunosorbent assay (elisa) system intended for in vitro diagnostic use to qualitatively detect the presence of lipoarabinomannan (lam) antigen of mycobacteria in human urine as an aid in the diagnosis of current mycobacterial infection in hiv positive patients with systems of tuberculosis.|in vitro|in vitro|in vitro|N|N
MI||OPU|Reagents, 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification|N|11|N|N|||8|2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens.|Reagent Kit|Nucleic acid amplification or antigen detection assays|The device is an in-vitro diagnostic device; none of the body parts will utilize the device or are intended to be affected by the device.|N|N
MI||ORL|T-Cell Xtend Reagent|3||N|N|||2|The T-Cell Xtend reagent is intended for use with the T-SPOT.TB test for the pre-treatment of whole blood prior to lymphocyte separation.  The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25c).|Liquid reagent|T-Cell Xtend contains bispecific monoclonal antibodies which are directed against cell surface markers on selected white blood cells and glycophorin A on red blood cells.  The T-Cell Xtend reagent cross-links the selected white blood cells with the red blood cells, which increases the density of the selected cells.  When a density gradient is applied during Ficoll extraction, the selected white blood cells remain separated into the red blood cell layer away from the PBMC layer and non-selected cells, including T cells and antigen presenting cells contained in the PBMC layer.|Whole blood samples|N|N
MI||OTT|Research Use Only/Microbiology|N|6|Y|N|||7|For research use only and for products imported into the US only.|N/A|N/A|N/A|N|N
MI||OYB|Kit, Rna Detection, Human Papillomavirus|3||N|N|||2|For the detection of human papillomavirus RNA to aid in assessing risk of cancer.|Device is supplied as an in vitro diagnositc kit containing various reagents, instructions for use and possibly instrumentation and software.|Utilizes nucleic acid probes and/or primers along with other reagents to detect human papillomavirus RNA directly from human specimens|Currently, this type of device is only utilized on cervical specimens, but other specimen types are possible.|N|N
MI||PAB|Cytomegalovirus (Cmv) Dna Quantitative Assay|3||N|N|||2|Cytomegalovirus (CMV) DNA Quantitative Assay is an in vitro nucleic acid assay for the quantitative measurement of CMV DNA in human plasma or whole blood. The assay can be used to measure CMV DNA levels serially at baseline and during the course of antiviral treatment to assess virological response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings.|IVD|In vitro nucleic acid based assay using real-time PCR for the quantitative measurement of CMV DNA|Not Applicable|N|N
MI||PCY|Investigational Use Only - Microbiology|N|6|Y|N|||7|Investigational use only and for products imported into the US only.|N/A|N/A|N/A|N|N
NE|CV|MOF|Guide, Wire, Catheter, Neurovasculature|2||N|P||870.1330|1|||||N|N
NE|CV|NCX|System, Hypothermia, Intravenous, Cooling|2||N|N||870.5900|1|||||N|N
NE|CV|NDQ|System, Catheter Or Guidewire, Steerable (Magnetic)|2||N|N||870.1290|1|||||N|N
NE|CV|NRY|Catheter, Thrombus Retriever|2||N|N||870.1250|1|The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke.  The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature.  It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.||||N|N
NE|CV|NUI|Ultrasound, Infusion, System|2||N|N||870.1200|1|FOR REGIONAL INFUSION OF CONTRAST MATERIALS INTO SELECTED VESSELS IN THE NEURO-VASCULATURE.  THE DEVICE MAY BE USED FOR CONTROLLED, REGIONAL INFUSION INTO SELECTED VESSELS AND IS NOT INTENDED FOR USE IN THE CORONARY VASCULATURE.||||N|N
NE|EN|PDQ|Neurosurgical Nerve Locator|2||N|N||874.1820|1|To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.|A user interface/control unit; handpiece with tip to deliver the electric current; and a separate monitoring electrode if detection is not built in the same tip.|Sends out electrical current, monitors for this current, and informs user of a change from baseline.|Spinal nerve roots or peripheral nerves|N|N
NE|NE|GWE|Stimulator, Photic, Evoked Response|2||N|P||882.1890|1|||||N|N
NE|NE|GWF|Stimulator, Electrical, Evoked Response|2||N|P||882.1870|1|||||N|N
NE|NE|GWG|Endoscope, Neurological|2||N|Y|M|882.1480|1|||||N|N
NE|NE|GWI|Discriminator,Two-Point|1||Y|N||882.1200|4|||||N|N
NE|NE|GWJ|Stimulator, Auditory, Evoked Response|2||N|P||882.1900|1|||||N|N
NE|NE|GWK|Conditioner, Signal, Physiological|2||N|P||882.1845|1|||||N|N
NE|NE|GWL|Amplifier, Physiological Signal|2||N|P||882.1835|1|||||N|N
NE|NE|GWM|Device, Monitoring, Intracranial Pressure|2||N|P||882.1620|1|||||N|N
NE|NE|GWN|Nystagmograph|2||N|P||882.1460|1|||||N|N
NE|NE|GWO|Plate, Cranioplasty, Preformed, Alterable|2||N|N||882.5320|1|||||Y|N
NE|NE|GWQ|Full-Montage Standard Electroencephalograph|2||N|Y|M|882.1400|1|Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations|May include standard electroencephalograph recording hardware (e.g. headbox, cables, computer, monitor, wireless) and basic software (e.g. used to display, store, archive, or manually annotate data).  Does NOT include electrodes, more complex software used to analyze electroencephalograph data or automatically detect events, electroencephalograph used for polysomnography or sleep studies, or electroencephalograph with less than 16 electrodes.|Uses electrodes (16 or more) placed on the scalp or within the brain, via user-specified locations, to record and display electrical activity of the brain|Brain|N|N
NE|NE|GWR|Generator, Electroencephalograph Test Signal|1||N|N||882.1430|4|||||N|N
NE|NE|GWS|Analyzer, Spectrum, Electroencephalogram Signal|1||N|Y|M|882.1420|1|||||N|N
NE|NE|GWW|Ataxiagraph|1||N|Y|M|882.1030|4|||||N|N
NE|NE|GWX|Fork, Tuning|1||Y|N||882.1525|4|||||N|N
NE|NE|GWY|Pinwheel|1||N|N||882.1750|4|||||N|N
NE|NE|GWZ|Percussor|1||Y|N||882.1700|4|||||N|N
NE|NE|GXB|Esthesiometer|1||Y|N||882.1500|4|||||N|N
NE|NE|GXC|Device, Electroconvulsive Therapy|3||N|N||882.5940|1|||||N|N
NE|NE|GXD|Generator, Lesion, Radiofrequency|2||N|P||882.4400|1|||||N|N
NE|NE|GXE|Leukotome|1||N|N||882.4600|4|||||N|N
NE|NE|GXH|Device, Surgical, Cryogenic|2||N|P||882.4250|1|||||N|N
NE|NE|GXI|Probe, Radiofrequency Lesion|2||N|P||882.4725|1|||||N|N
NE|NE|GXJ|Punch, Skull|1||N|N||882.4750|4|||||N|N
NE|NE|GXL|Screwdriver, Skullplate|1||N|N||882.4900|4|||||N|N
NE|NE|GXM|Anvil, Skull Plate|1||N|N||882.4030|4|||||N|N
NE|NE|GXN|Plate, Cranioplasty, Preformed, Non-Alterable|2||N|N||882.5330|1|||||Y|N
NE|NE|GXO|Strip, Craniosynostosis, Preformed|2||N|N||882.5900|1|||||Y|N
NE|NE|GXP|Methyl Methacrylate For Cranioplasty|2||N|N||882.5300|1|||||Y|N
NE|NE|GXQ|Dura Substitute|2||N|N||882.5910|1|||||Y|N
NE|NE|GXR|Cover, Burr Hole|2||N|N||882.5250|1|||||Y|N
NE|NE|GXS|Monitor, Alpha|2||N|P||882.1610|1|||||N|N
NE|NE|GXT|Monitor, Lesion Temperature|2||N|P||882.5500|1|||||N|N
NE|NE|GXW|Echoencephalograph|2||N|Y|M|882.1240|1|||||N|N
NE|NE|GXX|Block, Test, Ultrasonic Scanner Calibration|1||N|N||882.1925|4|||||N|N
NE|NE|GXY|Electrode, Cutaneous|2||N|P|M|882.1320|1|||||N|N
NE|NE|GXZ|Electrode, Needle|2||N|P||882.1350|1|||||N|N
NE|NE|GYA|Tester, Electrode/Lead, Electroencephalograph|1||N|N||882.1410|4|||||N|N
NE|NE|GYB|Media, Electroconductive|2||N|P||882.1275|1|||||N|N
NE|NE|GYC|Electrode, Cortical|2||N|Y||882.1310|1|||||N|N
NE|NE|GYD|Transducer, Tremor|2||N|P||882.1950|1|||||N|N
NE|NE|GYE|Encephalogram Telemetry System|2||N|P||882.1855|1|||||N|N
NE|NE|GYK|Instrument, Shunt System Implantation|1||N|Y|M|882.4545|4|||||N|N
NE|NE|GYZ|Stimulator, Intracerebral/Subcortical, Implanted|3||N|N||882.5840|2|Call for PMAs to be filed by 3/1/89 per 53 FR 43621 on 12/1/88||||Y|N
NE|NE|GZA|Implanted Cerebellar Stimulator|3||N|N||882.5820|2|Call for pmas 9/26/84 per 49 fr 26574 on 6/28/84||||Y|N
NE|NE|GZB|Stimulator, Spinal-Cord, Implanted (Pain Relief)|2||N|N||882.5880|1|||||Y|N
NE|NE|GZD|Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation|3||N|N||882.5850|2|Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96||||Y|N
NE|NE|GZF|Stimulator, Peripheral Nerve, Implanted (Pain Relief)|2||N|N||882.5870|1|||||Y|N
NE|NE|GZI|Stimulator, Neuromuscular, External Functional|2||N|P||882.5810|1|||||N|N
NE|NE|GZJ|Stimulator, Nerve, Transcutaneous, For Pain Relief|2||N|Y|M|882.5890|1|||||N|N
NE|NE|GZK|Electrode, Nasopharyngeal|2||N|P||882.1340|1|||||N|N
NE|NE|GZL|Electrode, Depth|2||N|P||882.1330|1|||||N|N
NE|NE|GZM|Analyzer, Rigidity|2||N|P||882.1020|1|||||N|N
NE|NE|GZN|Rheoencephalograph|3||N|N||882.1825|2|Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96||||N|N
NE|NE|GZO|Device, Galvanic Skin Response Measurement|2||N|P||882.1540|1|||||N|N
NE|NE|GZP|Stimulator, Mechanical, Evoked Response|2||N|P||882.1880|1|||||N|N
NE|NE|GZQ|Instrument, Dowel Cutting|2||N|P||882.4275|1|||||N|N
NE|NE|GZT|Retractor, Self-Retaining, For Neurosurgery|2||N|P||882.4800|1|||||N|N
NE|NE|GZX|Instrument, Microsurgical|1||N|N||882.4525|4|||||N|N
NE|NE|HAD|Rongeur, Powered|2||N|P||882.4845|1|||||N|N
NE|NE|HAE|Rongeur, Manual|2||N|P||882.4840|1|||||N|N
NE|NE|HAO|Instrument, Surgical, Non-Powered|1||N|N||882.4535|4|||||N|N
NE|NE|HAS|Needle, Neurosurgical Suture|1||N|N||882.4650|4|||||N|N
NE|NE|HAW|Neurological Stereotaxic Instrument|2||N|P||882.4560|1|||||N|N
NE|NE|HAX|Tong, Skull For Traction|2||N|P||882.5960|1|||||N|N
NE|NE|HBA|Neurosurgical Paddie|2||N|P||882.4700|1|||||N|N
NE|NE|HBB|Motor, Drill, Pneumatic|2||N|P||882.4370|1|||||N|N
NE|NE|HBC|Motor, Drill, Electric|2||N|P||882.4360|1|||||N|N
NE|NE|HBD|Handpiece (Brace), Drill|1||N|N||882.4325|4|||||N|N
NE|NE|HBE|Drills, Burrs, Trephines & Accessories (Simple, Powered)|2||N|P||882.4310|1|||||N|N
NE|NE|HBF|Drills, Burrs, Trephines & Accessories (Compound, Powered)|2||N|P||882.4305|1|||||N|N
NE|NE|HBG|Drills, Burrs, Trephines & Accessories (Manual)|2||N|P||882.4300|1|||||N|N
NE|NE|HBL|Holder, Head, Neurosurgical (Skull Clamp)|2||N|P||882.4460|1|||||N|N
NE|NE|HBM|Headrest, Neurosurgical|1||N|N||882.4440|4|||||N|N
NE|NE|HBN|Chair, Neurosurgical|1||N|N||882.4125|4|||||N|N
NE|NE|HBO|Clip, Scalp|2||N|P||882.4150|1|||||N|N
NE|NE|HBP|Clip, Implanted Malleable|2||N|N||882.5225|1|||||Y|N
NE|NE|HBQ|Instrument, Clip Removal|1||N|N||882.4200|4|||||N|N
NE|NE|HBR|Rack, Clip|1||N|N||882.4215|4|||||N|N
NE|NE|HBS|Instrument, Clip Forming/Cutting|1||N|N||882.4190|4|||||N|N
NE|NE|HBW|Fastener, Plate, Cranioplasty|2||N|N||882.5360|1|||||Y|N
NE|NE|HBX|Instrument, Cranioplasty Material Forming|1||N|N||882.4500|4|||||N|N
NE|NE|HBZ|Catheter, Intravascular Occluding|3||N|N||882.5150|2|Call for PMAs to be filed by 12/26/96 (61 FR 50708 (9/27/96))||||N|N
NE|NE|HCA|Catheter, Ventricular|2||N|P||882.4100|1|||||N|N
NE|NE|HCB|Device, Aversive Conditioning|2||N|P||882.5235|1|||||N|N
NE|NE|HCC|Device, Biofeedback|2||N|N||882.5050|4|||||N|N
NE|NE|HCD|Cannula, Ventricular|1||N|Y|M|882.4060|4|||||N|N
NE|NE|HCE|Clamp, Carotid Artery|2||N|N||882.5175|1|||||Y|N
NE|NE|HCG|Device, Neurovascular Embolization|2||N|N||882.5950|1|||||Y|N
NE|NE|HCH|Clip, Aneurysm|2||N|N||882.5200|1|||||Y|N
NE|NE|HCI|Applier, Aneurysm Clip|2||N|P||882.4175|1|||||N|N
NE|NE|HCJ|Device, Skin Potential Measurement|2||N|P||882.1560|1|||||N|N
NE|NE|HCS|Device, Temperature Measurement, Direct Contact, Powered|2||N|P||882.1570|1|||||N|N
NE|NE|JXE|Device, Nerve Conduction Velocity Measurement|2||N|P||882.1550|1|||||N|N
NE|NE|JXF|Plethysmograph, Ocular|3||N|N||882.1790|2|PMAs to be filed by 9/21/04 (69 FR 34920 (6/23/04))||||N|N
NE|NE|JXG|Shunt, Central Nervous System And Components|2||N|P||882.5550|1|||||Y|N
NE|NE|JXH|Methyl Methacrylate For Aneurysmorrhaphy|2||N|N||882.5030|1|||||Y|N
NE|NE|JXI|Cuff, Nerve|2||N|N||882.5275|1|||||Y|N
NE|NE|JXK|Stimulator, Cranial Electrotherapy|3||N|N||882.5800|1|||||N|N
NE|NE|JXL|Block, Bite|2||N|P||882.5070|1|||||N|N
NE|NE|LEM|Human Lyophilized Dura Mater|2||N|N||882.5975|1|Cber review required - previously regulated as a device under 21 cfr 882.5975, now regulated in cber under section 361 as banked human tissue. See definition at §1271.3(d).  Subject to donor eligibility, good tissue practice, registration and listing requirements under part 1271"  the good tissue practice regulation http://www.Fda.Gov/cber/rules/gtp.Pdf became final effective may 25, 2005.  It states that "on january 27, 2004, fda issued an interim final rule excepting human dura mater and human heart valve allografts from the definition of hct/p in § 1271.3(d) (69 fr 3823). Fda stated that, when the comprehensive framework is in place, fda intends that human dura mater and human heart valves will be subject to it, and that fda intends to revoke the interim rule at that time (69 fr 3823 and 3824). With the effective date of this final rule, fda is revoking the interim rule and revising the language in § 1271.3(d)."||||Y|N
NE|NE|LHG|Electrode, Spinal Epidural|2||N|N||882.5880|1|||||Y|N
NE|NE|MVA|Orthosis, Cranial|2||N|N||882.5970|1|||||N|N
NE|NE|MYU|Accessory,Barium Sulfate,Methyl Methacrylate For Cranioplasty|2||N|N||882.5300|1|||||Y|N
NE|NE|MZQ|Balloon,Detachable,For Neurovascular Occlusion|2||N|N||882.5950|1|||||Y|Y
NE|NE|NCG|Neuropsychiatric Interpretative Electroencephalograph Assessment Aid|2||N|N||882.1440|1|Uses a patient's electroencephalograph (EEG) to provide an interpretation of the patient's neuropsychiatric condition.  It is also used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis."|Software|Software analysis of EEG signals|Software|N|N
NE|NE|NFO|Stimulator, Transcutaneous Electrical, Aesthetic Purposes|2||N|N||882.5890|1|||||N|N
NE|NE|NHC|Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)|2||N|N||882.4100|1|Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain.||||Y|N
NE|NE|NHI|Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief|2||N|P||882.5890|1|Percutaneous electrical nerve stimulator (pens) is a device used for the treatment of pain.  Unlike the classified transcutaneous electrical nerve stimulator that apply an electrical current to electrodes on a patient's skin to deliver stimulation, a pens uses electrodes that are placed percutaneously to deliver stimulation,||||N|N
NE|NE|NLN|Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed|2||N|N||882.4310|1|||||N|N
NE|NE|NLO|Drills, Burrs, Trephines And Accessories (Manual), Reprocessed|2||N|N||882.4300|1|||||N|N
NE|NE|NLP|Drills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed|2||N|N||882.4305|1|||||N|N
NE|NE|NMN|Instrument, Clip, Forming/Cutting, Reprocessed|1||N|N||882.4190|1|||||N|N
NE|NE|NTU|Evoked Potential Stimulator, Thermal|2||N|P||882.1870|1|Intended to evaluate the functionality of human pain reception and transmission of sensory pathways||||N|N
NE|NE|NUF|Catheter, Neuro-Vasculature, Occluding Ballon|3||N|N||882.5150|2|Call for PMAs - 12/26/96 per 61 FR 50708 on 9/27/96 - For the treatment of cerebral ischemia resulting from symptomatic  vasospasm following aneurismal subarachnoid hemorrhage, secured by either  surgical or endovascular intervention for patients who have failed maximal  medical management||||N|Y
NE|NE|NUH|Stimulator, Nerve, Transcutaneous, Over-The-Counter|2||N|N||882.5890|1|TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES||||N|N
NE|NE|NYN|Stimulator, Electrical, Transcutaneous, For Arthritis|2||N|N||882.5890|1|Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through electrodes on patient's skin to provide relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).|Electrical stimulation unit with leads and cutaneous electrodes.|Applies an electrical current through electrodes on patient's skin.|Over or in proximity to affected joint.|N|N
NE|NE|NYW|Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief|2||N|N||882.5890|1|Nerve stimulation for relief of pain|Electrical stimulation unit with leads and cutaneous electrodes|Stimulation of nerves using electrical current applied to electrodes on a patient's skin|Electrodes are placed on the skin in proximity to the painful area|N|N
NE|NE|NYX|Stimulator, Electrical, Transcutaneous, With Limted Output, For Aesthetic Purposes|2||N|Y||882.5890|1|Electrical stimulation for aesthetic purposes|Electrical stimulation unit with leads and cutaneous electrodes|Electrical stimulation using current applied to electrodes on a patient's skin|Electrodes are placed on the skin in proximity to the area of interest|N|N
NE|NE|OBV|Eating Disorder Conditioning Tool|2||N|N||882.5060|1|A conditioning tool for eating disorders is a medical device that non-invasively measures the mass of food eaten during a meal and provides feedback in the form of eating rate, patient satiety, and eating pattern information to the patient.|A flat scale is connected to a monitor which records data and displays the food consumption rate.  The monitor also prompts the user for satiety sensation and displays trend.|Uses scale to meaure weight of plate during meal.  Prompts user to provide feedback on satiety during meal.  Provides display for actual and target food consumption rate.|brain and stomach|N|N
NE|NE|OCF|Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief|2||N|N||882.5890|1|Electrical stimulation of nerves for relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). Relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).|Electrical stimulation unit with leads and cutaneous electrodes.|Applies an electrical current through electrodes on a patient's skin.|Electrodes are placed on the skin to stimulate nerves in proximity to the painful joint.|N|N
NE|NE|OJG|Neurological Tray|1||N|N||882.4525|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
NE|NE|OJP|Orthopedic Computer Controlled Surgical System|2||N|N||882.4560|1|Pre-operative planning and intra-operative execution of surgical movements with robotically controlled end effectors under user supervision.  Alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).|Preoperative Planning Workstation, a robotic arm, electronics control cabinet, display monitor and miscellaneous accessories (such as cutters, drapes, irrigation sets, probes and markers).|The system registers patient anatomy to a pre-operative surgical plan to guide a robotic arm during the milling of the femeral canal for primary total hip arthroplasty.|Orthopedic Surgery - Hard tissue.|N|N
NE|NE|OKP|Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache|2||N|N||882.5808|1|Transcranial magnetic stimulator for the treatment of migraine headache delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electric currents for the treatment of migraine headache.|The device includes a magnetic coil, power modules, software, and user interface.|Delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electric currents in the brain.|Stimulation to the head.|N|N
NE|NE|OLT|Non-Normalizing Quantitative Electroencephalograph Software|2||N|Y||882.1400|1|Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.|Electroencephalograph analysis software.  Does NOT include electrodes, amplitude-integrated electroencephalograph, automatic event-detection software, software that compares data to a database (normal or otherwise) or electroencephalograph software that outputs an index, classification, diagnosis, or any clinical interpretation of the data.|Uses software algorithms as a tool to analyze electroencephalograph (from user-specified electrode number and locations) and automatically calculate conventional electroencephalograph parameters. (e.g. spectral edge frequency, total power, percent alpha, asymmetry).|Brain|N|N
NE|NE|OLU|Normalizing Quantitative Electroencephalograph Software|2||N|Y||882.1400|1|Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.|Electroencephalograph analysis software.  Does NOT include electrodes, amplitude-integrated electroencephalograph, automatic event-detection software,  software that compares data to non-normative databases, software that does not compare to a normative database or electroencephalograph software that outputs an Index, classification, diagnosis or any clinical interpretation of the data.|Uses software algorithms as a tool to analyze electroencephalograph (from user-specified electrode number and locations) and automatically calculates conventional electroencephalograph parameters. (e.g. power, asymmetry, coherence) and normalizes the data by comparison to a normative database; output is a z-score, standard deviation or some other quantification of difference between subject and normative values.|Brain|N|N
NE|NE|OLV|Standard Polysomnograph With Electroencephalograph|2||N|Y||882.1400|1|Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings.  May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.|May include standard polysomnography recording hardware (e.g. headbox, cables, computer, monitor, wireless) and basic software (e.g. used to display, store, archive, or manually annotate data).  Does NOT include electrodes, vital signs monitors, polysomnography devices without electroencephalograph, more complex software used to analyze electroencephalograph data or software used to automatically detect events.|Uses electrodes placed on the scalp, within the brain, or other locations, via user-specified locations, to record and display electrical activity of the brain and other organs|Brain|N|N
NE|NE|OLW|Index-Generating Electroencephalograph Software|2||N|N||882.1400|1|Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.|Electroencephalograph analysis software, either developed by 510(k) holder for use in their own hardware or licensed from another company for use in 510(k) holder's hardware.  Does NOT include electrodes, amplitude-integrated electroencephalograph, automatic event-detection software, electroencephalograph software with comparative databases (normal or otherwise) or electroencephalograph software that outputs a diagnosis or classification.|Uses software algorithms, developed from and trained with specific patient datasets, to analyze electroencephalograph from 1 to 16 electrodes at sponsor-specified locations; also may output one or several signal quality indicators|Brain|N|N
NE|NE|OLX|Source Localization Software For Electroencephalograph Or Magnetoencephalograph|2||N|Y||882.1400|1|Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization|Software algorithm.  Does NOT include electrodes, amplitude-integrated electroencephalograph, automatic event-detection software used as the only or final electroencephalograph analysis step, electroencephalograph software with comparative databases (normal or otherwise) or electroencephalograph software that outputs an index, diagnosis, or classification.|Uses software algorithms that correlate the electroencephalograph to one or several types of neuroimaging data.  May include use of event-detection algorithms (that require user confirmation) as an intermediary, but not final, step.|Brain|N|N
NE|NE|OLY|Magnetoencephalograph|2||N|Y||882.1400|1|Acquire, display, store, and archive biomagnetic signals produced by electrically active nerve tissue in the brain to provide information about the location of active nerve tissue responsible for certain brain functions relative to brain anatomy.|Magnetoencephalograph recording device (hardware, basic software)|Uses a helmet with sensors to record the magnetic activity of the brain|Brain|N|N
NE|NE|OLZ|Automatic Event Detection Software For Polysomnograph With Electroencephalograph|2||N|N||882.1400|1|Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user|Electroencephalograph analysis software.  Does NOT include electrodes, electroencephalograph hardware, polysomnograph hardware, or basic electroencephalograph/polysomnograph software (e.g. used to display, store, archive, or manually annotate data).|Uses software algorithms to analyze electroencephalograph and polysomnograph waveforms and automatically identify areas of interest to the user|Brain|N|N
NE|NE|OMA|Amplitude-Integrated Electroencephalograph|2||N|Y||882.1400|1|Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).|May include standard electroencephalograph recording hardware (e.g. headbox, cables, computer, monitor, wireless) and basic software (e.g. used to display, store, archive, or manually annotate data).  Does NOT include electrodes, more complex software used to analyze the amplitude-integrated electroencephalograph signal, software used to automatically detect events, electroencephalograph used for polysomnography or sleep studies, or standard electroencephalograph (full- or reduced- montage).|Uses a specific combination of filters, a semi-logarithmic scale and bipolar electrode placements (via user-specified  and/or sponsor-specified locations), to record and display electrical activity of the brain.|Brain|N|N
NE|NE|OMB|Automatic Event Detection Software For Full-Montage Electroencephalograph|2||N|N||882.1400|1|Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user|Electroencephalograph analysis software.  Does NOT include electrodes, electroencephalograph hardware, basic electroencephalograph software (e.g. used to display, store, archive, or manually annotate data),  or automatic event detection software used as an intermediary step in source-localization analysis.|Uses software algorithms to analyze full-montage electroencephalograph (16 electrodes) at user-specified locations and automatically identify areas of interest.|Brain|N|N
NE|NE|OMC|Reduced- Montage Standard Electroencephalograph|2||N|Y||882.1400|1|Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes|May include standard EEG recording hardware (e.g. headbox, cables, CPU, monitor and basic software (needed to display, store and archive EEG and allow user-only annotation and marking); does NOT include electrodes, more complex software used to analyze EEG or automatically detect events, EEG used for PSG or sleep studies, or EEG with > 16 electrodes or more electrodes.|Uses electrodes (less than < 16) placed on the scalp or within the brain, via user-specified  and/or sponsor-specified locations, to record and display electrical activity of the brain|Brain|N|N
NE|NE|ONN|Intraoperative Orthopedic Joint Assessment Aid|2||N|Y|M|882.4560|1|Measurement and interpretation of orthopedic joint information.|Measurement transducer, central processing unit, and user interface.|The system analytically measures the joint state and interprets the measurements using a software algorithm to aid in the positioning of an implant system.|Orthopedic joint.|N|N
NE|NE|ORS|Magnetotherapy Device For Pain Relief|2||N|N||882.5890|1|Simptomatic relief of chronic intractable, post-traumatic and post-surgical pain|electronic device (generator) with electromagnetic coils, which can be attached to the body as patches or brought to the eproximity of the treated area.|inducing electrical current in the tissues by means of passing alternatng electrical current through the electromagnetic coil(s).|below neck|N|N
NE|NE|ORT|Burst Suppression Detection Software For Electroencephalograph|2||N|N||882.1400|1|Automatically mark or identify electroencephalograph waveforms for rhythmic patterns of burst suppression in order to aid in identification of such events and help in the review and annotation of prolonged EEG traces; software can also quantify simple characteristics of the burst suppression such as inter-burst interval or count; all output subject to verification by qualified user.|Electroencephalograph analysis software.  Does NOT include electrodes, electroencephalograph hardware, basic electroencephalograph software (e.g. used to display, store, archive, or manually annotate data), automatic event (i.e., seizure) detection software or automatic event-detection software used as an intermediary step in source-localization analysis.|Uses simple, transparent software algorithms to analyze any size montage (full or reduced) for burst suppression patterns and automatically identify areas of interest or quantify pattern characteristics.|Brain|N|N
NE|NE|OSG|Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch|2||N|N||882.5895|4|Relief / Reduction of Mosquito Bite Itch|The device is hand-held, composed of an insulated housing which contains a piezo-electric crystal and conductive elements to deliver charge to the skin, as well as a moving mechanical part to allow the intended user to generate the force to produce the electrical charge.|Electrical charge, generated via piezo-electric crystal, delivered transcutaneously at the site of the mosquito bite. The piezo-electric crystal generates electrical charge by the application of a manual mechanical force.|Intended to be placed on the skin, at the site of a mosquito bite.|N|N
NE|NE|PAV|Catheter, Neuro-Vasculature, Occluding Balloon|f||N|N||882.5150|6|Used to obstruct lower aortic blood flow to augment cerebral perfusion.|A multi-lumen catheter with two balloons mounted near the distal tip|Temporary balloon inflation in the descending aortic artery obstructs or redirect blood flow|Double balloon catheter deployed in the descending aortic artery and hypothesized to increase cerebral blood flow|N|N
NE|NE|PBJ|Cranial Distraction System|2||N|N||882.5330|1|A cranial distraction system is a metal device intended to establish osteodistraction and bone growth in the skull.  The bone segments are attached to the plate with screws to prevent movement of the segments.|May include: distractors, distraction plates, spacers, screws and instrumentation|Bone segments are attached to the plate with screws to prevent movement of the segments.|Cranium, skull|Y|Y
NE|NE|PCB|External Cerebrospinal Fluid (Csf) Diversion|2||N|N||882.5560|1|Cerebrospinal fluid (CSF) diversion intended to alter spinal cord perfusion.|CSF drainage system.|Diverts CSF in order to alter spinal cord perfusion pressures.|Central nervous system (CNS) subarachnoid and ventricular space.|N|N
NE|NE|PCC|Stimulator, Nerve, Electrical, Transcutaneous, For Migraine|2||N|N||882.5891|1|Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.|Electrical stimulation unit with leads and cutaneous electrodes.|Applies an electrical current through electrodes on patient's skin.|Afferent cranial nerves.|N|N
NE|NE|PIW|Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid|2||N|N||882.1450|1|A prescription device that uses a patient¿s electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient¿s brain in the setting of trauma.  The Brain Injury Adjunctive Interpretive EEG Assessment Aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.|Handheld EEG recording device, electrodes, and data analysis software|Software analysis of EEG signals|Forehead, scalp|N|N
NE|NE|PIY|Stainless Steel Instrument, Shunt System Implantation|1||N|N||882.4545|4|A stainless steel shunt system implantation instrument is an instrument made entirely of stainless steel used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin.|Instrument|The device is used as an instrument to place cerebrospinal fluid shunts.|Cranium, Skull|N|N
NE|NE|PJM|Filler, Bone Void, Alterable Compound For Cranioplasty|2||N|N||882.5320|1|An alterable cranial bone void filler is a device intended to be a bone substitute for the replacement of bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton, and are not intrinsic to the stability of the bony structure. The device is constructed from a material (e.g., calcium, polymer synthetic-based, etc.) that can be reshaped or altered at the time of surgery or after implantation without changing the chemical behavior of the material.|Preformed Implant|The device is implanted in the bony void and may be secured using plates and screws to prevent the movement of the cranial bone void filler.|Cranium, Skull|Y|N
NE|NE|PJN|Filler, Bone Void, Nonalterable Compound For Cranioplasty|2||N|N||882.5330|1|A nonalterable cranial bone void filler is a device that is created from patient-specific computerized tomography (CT) imaging data and intended to fill bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton, and are not intrinsic to the stability of the bony structure. The materials used (e.g., metals, polyether ether ketone (PEEK), etc.) in the construction of the nonalterable cranial bone void fillers are not resorbable and cannot be altered or reshaped at the time of surgery or after implantation without changing the chemical behavior of the material.|Manufactured as Patient-Specific Preformed Implant|The device is implanted in the bony void and may be secured using plates and screws to prevent the movement of the cranial bone void filler.|Cranium, Skull|Y|N
NE|NE|PKQ|Computerized Cognitive Assessment Aid|2||N|N||882.1470|1|The computerized cognitive assessment aid provides clinicians in a healthcare setting with objective measurements of cognitive function as a screening aid in the assessment of adults 55 years of age and older. This is done for the purpose of identifying a potential decline in cognitive function relative to baseline test performance of other age-normal adults, referring those adults for further testing where warranted, and monitoring changes in cognitive function over time|Computer-administered battery of cognitive tests, computer keyboard, computer screen.|Uses a battery of objective cognitive tests delivered by computer software to determine an individual's current level of cognitive functioning.|Brain|N|N
NE|PM|IKN|Electromyograph, Diagnostic|2||N|P||890.1375|1|||||N|N
NE|PM|IKT|Electrode, Needle, Diagnostic Electromyograph|2||N|Y||890.1385|1|||||N|N
NE|PM|NZY|Light, Lymphedema Reduction, Low Energy|2||N|N||890.5500|1|Intended for use as a tool as part of a therapy regime for the low level light treatment of post mastectomy lymphedema and indicated for use as a tool as part of a therapy regime for the treatment of post mastectomy lymphedema.|Unit is a hand-held battery powered treatment device, is non-thermal and is used in the contact mode.|Device is non-thermal and delivers a controlled series of 200 ns bursts of pulses of 904nm laser beam, which is in the near infrared spectrum that is invisible to the human eye|Arms of women who have been treated for cancer and have developed post mastectomy lymphedema|N|N
NE|PM|OTX|Foot Wrap For Treating Restless Leg Syndrome Symptoms|1||N|N||890.5760|4|Applying compression to the muscles of the foot for the purpose of affecting nerve impulses sent to the central nervous system.|Compressive wrap.|Applies pressure to the abductor hallucis and abductor hallucis brevis adequate to affect the peripheral nervous system.|Abductor hallucis and abductor hallucis brevis muscles.|N|N
NE|PM|PHL|Powered Exoskeleton|2||N|N||890.3480|1|A powered exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis used for medical purposes that is placed over a person's paralyzed or weakened limbs for the purpose of providing ambulation.|The device is a wearable exoskeleton device that allows the user to enable ambulation over the course of the day.  The control of the device is achieved through a wrist-worn user-operated wireless communicator, tilt sensor and specific body movements|The movement of the swing leg is controlled by a seat of gears and DC motors at the knee and hip joints.  Minimizing energy expenditure with gait approximation is critical for maximizing battery life between charges.|The device legs consist of left and right interconnect hip and knee segments.  Multiple attachment straps are mounted along the length of each leg.  The pelvic band support provides a structure to join the two legs together and the pelvic strap helps hold the user firmly in the system.  A tilt sensor is mounted on the left side of the pelvic band.  The ankle/foot bed holds the calves of the user to the system.|N|N
NE|SU|ONO|Neurosurgical Laser With Mr Thermography|2||N|Y|M|878.4810|1|Laser device for use to necrotize or coagulate soft tissue through interstitial irradition or thermal therapy under mri guidance and real time mr thermography in neurosurgery.|Laser system under MRI guidance and MR thermography|Laser energy to necrotize or coagulate brain tissue.|Brain tissue|N|N
NE||BWK|Stimulator, Electro-Acupuncture|U|1|N|N|||1|||||N|N
NE||KGF|Adhesive, Tissue For Aneurysmorrhaphy|3||N|N|||2|||||Y|N
NE||KGG|Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations|3||N|N|||2|||||N|N
NE||LBK|Device, Neurosurgical Fragmentation And Aspiration|U|1|N|N|||1|||||N|N
NE||LEL|Device, Sleep Assessment|U|1|N|N|||1|||||N|N
NE||LGW|Stimulator, Spinal-Cord, Totally Implanted For Pain Relief|3||N|N|||2|||||Y|N
NE||LHY|Electrode, Stabilized Epidural Spinal|3||N|N|||2|||||Y|N
NE||LIH|Interferential Current Therapy|U|1|N|N|||1|||||N|N
NE||LII|Monitor, Intracranial Pressure, Implanted|3||N|N|||2|||||Y|N
NE||LKW|Laser, Neurosurgical|3||N|N|||3|||||N|N
NE||LLE|Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease|3||N|N|||3|||||Y|N
NE||LLF|Laser, Neurosurgical, Argon|3||N|N|||3|||||N|N
NE||LLN|Device, Vibration Threshold Measurement|N|6|N|N|||4|||||N|N
NE||LME|Monitor, Blood-Flow, Cerebral, Thermal Diffusion|3||N|N|||3|||||N|N
NE||LQD|Recorder, Attention Task Performance|U|1|N|N|||1|||||N|N
NE||LQW|Test, Temperature Discrimination|N|6|N|N|||4|||||N|N
NE||LYI|Stimulator, Subcortical, Implanted  For Epilepsy|3||N|N|||3|||||Y|N
NE||LYJ|Stimulator, Autonomic Nerve, Implanted For Epilepsy|3||N|N|||2|||||Y|N
NE||MFE|Agent, Injectable, Embolic|3||N|N|||2|||||N|N
NE||MFR|Stimulator, Brain, Implanted, For Behavior Modification|f||N|N|||6|||||Y|N
NE||MHY|Stimulator, Electrical, Implanted, For Parkinsonian Tremor|3||N|N|||2|||||Y|N
NE||MHZ|Stimulator, Vestibular Acceleration, Therapeutic|3||N|N|||3|||||N|N
NE||MKD|Stimulator, Functional Walking Neuromuscular, Non-Invasive|3||N|N|||2|||||N|N
NE||MRU|Implanted Subcortical Electrical Stimulator (Motor Disorders)|f||N|N|||6|||||Y|N
NE||MUZ|Stimulator, Autonomic Nerve, Implanted (Depression)|3||N|N|||2|The device is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.||||Y|N
NE||MVV|Device, Acupressure|U|1|N|N|||1|||||N|N
NE||MXM|Cap,Cooling (Infants)|3||N|N|||2|Indicated for use in full-term infants with clinical evidence of moderate to severe hypoxic-ischemic encephalopathy (HIE)*.  Provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE.||||N|N
NE||NHL|Stimulator, Electrical, Implanted, For Parkinsonian Symptoms|3||N|N|||2|Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinsons disease that are not adequately controlled with medication.||||Y|N
NE||NJE|Intracranial Neurovascular Stent|f||N|N|||6|An intracranial neurovascular stent is a tubular device placed in the blood vessel of the intracranial cavity to treat a vascular abnormality.  It differs from other stents in that it is intended for intracranial use.||||Y|N
NE||NPE|Material, Embolization, Neurovascular, Polymerizing Or Precipitating|3||N|N|||2|This is an neurovascular embolization device which is placed in a blood vessel to permanently obstruct blood flow to an aneurysm or other vascular malformation.  It is unlike the coil or particulate embolization devices in that it polymerizes or precipitates in situ.  Particulate or coil-based embolic agents are delivered in pre-formed shapes and configurations.||||N|Y
NE||NQR|Sealant, Dural|3||N|N|||2|Dural sealants are devices intended to aid in preventing cerebrospinal fluid leakage through suture-approximated dural wound edges.  The sealant is sprayed or layered onto sutured dural wound edges and allowed to polymerize in place.||||Y|Y
NE||NZK|Stimulator, Low Electric Field, Tumor Treatment|3||N|N|||2|Intended to treat tumors by application of low electic fields and indicated for treatment of recurrent glioblastoma multiforme (gbm) in patients who have received maximum standard therapy with continued disease progress, as defined by tumor growth or decline in neurological status.|The device consists of sets of contact electrodes that are applied to the patient's shaved head, a connecting cable and a belt mounted control box and signal generator.  The sets are 3 electrodes each adn there can be 2 or 3 sets used at a time.|This is a battery powered device.  Electric fields that alter thier polarity at a frequency near 200kHz with an intensity near 0.7 V/cm are continuosly applied to the target tumor 24 hours a day for 6 months at a time.  This electric field creates, during mitosis process, disruption of the microtubules due to the focussing effect of the narrow neck of the dividing cell.|The device is currently used only on the human head.|N|Y
NE||OBA|Polymerizing, Neurovascular Embolization Material|f||N|N|||6|The neurovascular embolization device is placed in a blood vessel to permanenty obstruct blood flow to an intracranial aneurysm or other vascular malformation.   The device polymerizes or precipitates in situ.|the embolization agent is dissolved in DMSO (dimethyl sulfoxide, an organic solvent); ethylene vinyl alcohol co-polymer (EVOH, the embolization agent) upon contact with aqueous solutions such as blood or saline, precipitates in situ forming a spongy/solid embolus - the micro-catheter is threaded up through the femoral artery into the brain and to the site of the aneurysm.  The embolic solution (EVOH plus DMSO) is slowly infused, and thereby the material precipitates.|intravascular embolization|intracranial aneurysms as specified by indication statement|Y|Y
NE||OLM|Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)|f||N|N|||6|The device is indicated for bilateral stimulation of the anterior limb of the internal capsule, this device is indicated as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant Obsessive Compulsive Disorder (OCD) in adult patients who have failed at least three Selective Serotonin Reuptake Inhibitors (SSRIs).|Electrodes, extension and IPG|Deep brain stimulation|Anterior limb of the internal capsule in the brain|Y|N
NE||OUT|Intracranial Aneurysm Flow Diverter|3||N|N|||2|Treatment of wide-necked and larger or giant intracranial aneurysms.|metallic|interventional|neurovasculature|Y|N
NE||OUU|Polymeric Neurovascular Embolization |f||N|N|||6|Treatment of intracranial aneurysms|Polymer|Neurointerventional|Neurovasculature|Y|N
NE||OVC|Headframe|N|3|Y|N|||3|To enhance mechanical thrombus dissolution and acceleration of thrombolysis in patients suffering acute ischemic stroke.|made of mostly plastic and has an adjustable frame|Uses ultrasound transducers mounted on a headframe to deliver transcranial ultrasound at diagnostic levels.|Head|N|N
NE||PAX|Surgical Kit|f||N|N|||6|For creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity.|Arteriotomy SystemHUD and extension tubing for connection to a vacuum source. It is comprised of the catheter and the rings.      The Elana Surgical KitHUD should only be used with the US legally marketed Spectranetics XeCl (Xenon-Chloride) Excimer Laser System, Model CVX-300.|The surgeon attaches the ring  with the donor graft to the artery wall  using a fine suture. Apply suction. For about 2 minutes the catheter tip should be held in steady contact with the artery wall.  After the two minutes, the Excimer laser is activated). A train of pulses is delivered. When 200 pulses are delivered, the laser will stop automatically. The surgeon slowly removes the catheter and checks for a retrograde blood flow through the donor graft before occluding it.|Neurovascular arteries|N|N
NE||PFN|Implanted Brain Stimulator For Epilepsy|3||N|N|||2|For the treatment of epilepsy.|The main components of the device include implanted leads (depth and cortical), implanted neurostimulator, and external programmers.|Uses an implanted neurostimulator to sense ECoG activity and provide stimulation to depth and/or cortical leads.|seizure focii in the brain|Y|N
NE||PJS|Stimulator, Electrical, Implanted, For Essential Tremor|3||N|N|||2|Deep Brain Stimulation for the treatment of essential tremor|System components include implantable pulse generator, leads, extensions, patient programmer, and charger|Implantable pulse generator will produce electrical pulses which will stimulate deep brain structures through electrodes on leads.|Deep Brain Structures|Y|N
OB|CH|LNW|Paper, Obstetric Ph|1||N|N||862.1550|4|||||N|N
OB|CV|NAJ|Agents,Embolic,For Treatment Of Uterine Fibroids|2||N|N||870.3300|1|||||Y|N
OB|OB|FHG|Bell, Circumcision|2||N|N||884.4530|4|||||N|N
OB|OB|FHJ|Shield, Circumcision|2||N|N||884.4530|4|||||N|N
OB|OB|HCY|Curette, Uterine|1||N|N||884.4530|4|||||N|N
OB|OB|HCZ|Forceps, Surgical, Gynecological|2||N|P||884.4530|1|||||N|N
OB|OB|HDA|Forceps, Obstetrical|2||N|P||884.4400|4|||||N|N
OB|OB|HDB|Extractor, Vacuum, Fetal|2||N|P||884.4340|1|||||N|N
OB|OB|HDC|Tenaculum, Uterine|2||N|P||884.4530|1|||||N|N
OB|OB|HDD|Table, Obstetrical, Ac-Powered (And Accessories)|2||N|P||884.4900|1|||||N|N
OB|OB|HDE|Hook, Fibroid, Gynecological|1||N|N||884.4520|4|||||N|N
OB|OB|HDF|Speculum, Vaginal, Metal|1||N|N||884.4520|4|||||N|N
OB|OB|HDG|Speculum, Vaginal, Metal, Fiberoptic|1||N|N||884.4520|4|||||N|N
OB|OB|HDH|Needle, Cerclage, Gynecological|1||N|N||884.4530|4|||||N|N
OB|OB|HDI|Hook, Destructive, Obstetrical|2||N|P||884.4500|1|||||N|N
OB|OB|HDJ|Scissors, Umbilical|1||N|N||884.4520|4|||||N|N
OB|OB|HDK|Scissors, Episiotomy|1||N|N||884.4520|4|||||N|N
OB|OB|HDL|Retractor, Vaginal|1||N|N||884.4520|4|||||N|N
OB|OB|HDM|Packer, Uterine|1||N|N||884.4520|4|||||N|N
OB|OB|HDN|Dilator, Cervical, Expandable|3||N|N||884.4250|2|Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96||||N|N
OB|OB|HDO|Valve, Tubal Occlusion|3||N|N||884.5380|2|Call for PMAs 12/30/87 (52 FR 36883 10/1/87))||||Y|N
OB|OB|HDP|Elevator, Uterine|2||N|P||884.4530|1|||||N|N
OB|OB|HDQ|Dilator, Cervical, Fixed Size|1||N|N||884.4530|4|||||N|N
OB|OB|HDR|Cap, Cervical|2||N|P||884.5250|1|||||N|N
OB|OB|HDT|Device, Intrauterine, Contraceptive And Introducer|3||N|N||884.5360|2|Called for PMAs in FR 5/5/86 PMAs to be filed by 8/4/86||||Y|N
OB|OB|HDW|Diaphragm, Contraceptive (And Accessories)|2||N|P||884.5350|1|||||N|N
OB|OB|HDX|Dilator, Vaginal|2||N|P||884.3900|1|||||N|N
OB|OB|HDY|Dilator, Cervical, Hygroscopic-Laminaria|2||N|P||884.4260|1|||||N|N
OB|OB|HDZ|Knife, Cervical Cone|2||N|P||884.4530|1|||||N|N
OB|OB|HEA|Clip, Drape, Lithotomy|2||N|P||884.4900|1|||||N|N
OB|OB|HEB|Tampon, Menstrual, Unscented|2||N|Y||884.5470|1|||||N|N
OB|OB|HEC|Insufflator, Vaginal|1||N|N||884.5920|4|||||N|N
OB|OB|HED|Douche Apparatus, Vaginal, Therapeutic|1||N|N||884.5900|4|||||N|N
OB|OB|HEE|Set, Anesthesia, Paracervical|2||N|P||884.5100|1|||||N|N
OB|OB|HEG|Set, Anesthesia, Pudendal|2||N|P||884.5100|1|||||N|N
OB|OB|HEH|Chamber, Decompression, Abdominal|3||N|N||884.5225|2|||||N|N
OB|OB|HEI|Monitor, Heart-Valve Movement, Fetal, Ultrasonic|2||N|Y|M|884.2660|1|||||N|N
OB|OB|HEJ|Monitor, Hemic Sound, Ultrasonic|2||N|Y|M|884.2660|1|||||N|N
OB|OB|HEK|Monitor, Heart Sound, Fetal, Ultrasonic|2||N|Y|M|884.2660|1|||||N|N
OB|OB|HEL|Monitor, Heart Rate, Fetal, Ultrasonic|2||N|Y|M|884.2660|1|||||N|N
OB|OB|HEM|Imager, Ultrasonic Obstetric-Gynecologic|2||N|Y|M|884.2225|1|||||N|N
OB|OB|HEN|Caliper, Fetal Head, Ultrasonic|2||N|Y|M|884.2225|1|||||N|N
OB|OB|HEO|Analyzer, Data, Obstetric|3||N|N||884.2050|2|Call for PMAs to be filed by 10/3/00 per 65 FR 41332 on 7/5/00||||N|N
OB|OB|HEP|Monitor, Blood-Flow, Ultrasonic|2||N|Y|M|884.2660|1|||||N|N
OB|OB|HEQ|Monitor, Pressure, Arterial, Fetal, Ultrasonic|2||N|Y|M|884.2660|1|||||N|N
OB|OB|HER|Pelvimeter, External|1||N|N||884.4520|4|||||N|N
OB|OB|HES|Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)|2||N|P||884.1300|1|||||N|N
OB|OB|HET|Laparoscope, Gynecologic (And Accessories)|2||N|Y|M|884.1720|1|||||N|N
OB|OB|HEW|Culdoscope (And Accessories)|2||N|N||884.1640|1|||||N|N
OB|OB|HEX|Colposcope (And Colpomicroscope)|2||N|P||884.1630|1|||||N|N
OB|OB|HEZ|Endoscope, Transcervical (Amnioscope)(And Accessories)|2||N|P||884.1660|1|||||N|N
OB|OB|HFA|Amnioscope, Transabdominal (Fetoscope) (And Accessories)|f||N|N||884.1600|6|||||N|N
OB|OB|HFB|Forceps, Biopsy, Gynecological|1||N|N||884.4530|4|||||N|N
OB|OB|HFC|Aspirator, Endocervical|2||N|P||884.1050|1|||||N|N
OB|OB|HFD|Washer, Endometrial|2||N|P||884.1185|1|||||N|N
OB|OB|HFE|Brush, Endometrial|2||N|P||884.1100|1|||||N|N
OB|OB|HFF|Aspirator, Endometrial|2||N|P||884.1060|1|||||N|N
OB|OB|HFG|Coagulator, Laparoscopic, Unipolar (And Accessories)|2||N|P||884.4160|1|||||N|N
OB|OB|HFH|Coagulator, Hysteroscopic (And Accessories)|2||N|P||884.4160|1|||||N|N
OB|OB|HFI|Coagulator, Culdoscopic (And Accessories)|2||N|P||884.4160|1|||||N|N
OB|OB|HFJ|Prosthesis, Fallopian Tube|2||N|N||884.3650|1|||||Y|N
OB|OB|HFK|Mold, Vaginal|2||N|P||884.3900|1|||||N|N
OB|OB|HFL|Drain, Cervical|2||N|P||884.3200|4|||||N|N
OB|OB|HFM|Monitor, Uterine Contraction, External (For Use In Clinic)|2||N|P||884.2720|1|||||N|N
OB|OB|HFN|Transducer, Pressure, Intrauterine|2||N|P||884.2700|1|||||N|N
OB|OB|HFO|Recorder, Pressure, Intrauterine|2||N|P||884.2700|1|||||N|N
OB|OB|HFP|Monitor, Phonocardiographic, Fetal|2||N|P||884.2640|1|||||N|N
OB|OB|HFW|Clamp, Umbilical|2||N|P||884.4530|4|||||N|N
OB|OB|HFX|Clamp, Circumcision|2||N|P||884.4530|1|||||N|N
OB|OB|HFY|Band, Tubal Occlusion|3||N|N||884.5380|2|Call for PMAs 12/30/87 (52 FR 36883 10/1/87))||||Y|N
OB|OB|HFZ|Craniotribe|2||N|P||884.4500|1|||||N|N
OB|OB|HGA|Cranioclast|2||N|P||884.4500|1|||||N|N
OB|OB|HGB|Clip, Tubal Occlusion|3||N|N||884.5380|2|Call for PMAs 12/30/87 (52 FR 36883 10/1/87))||||Y|N
OB|OB|HGC|Clamp, Uterine|1||N|N||884.4520|4|||||N|N
OB|OB|HGD|Applicator, Vaginal|1||N|N||884.4520|4|||||N|N
OB|OB|HGE|Amniotome|1||N|N||884.4530|4|||||N|N
OB|OB|HGF|Source, Abortion Unit, Vacuum|2||N|P||884.5070|1|||||N|N
OB|OB|HGG|Controller, Abortion Unit, Vacuum|2||N|P||884.5070|1|||||N|N
OB|OB|HGH|Cannula, Suction, Uterine|2||N|P||884.5070|1|||||N|N
OB|OB|HGI|Electrocautery, Gynecologic (And Accessories)|2||N|Y||884.4120|1|||||N|N
OB|OB|HGK|Endoscope, Fetal Blood Sampling (And Accessories)|2||N|P||884.1660|1|||||N|N
OB|OB|HGL|Transducer, Ultrasonic, Obstetric|2||N|Y|M|884.2960|1|||||N|N
OB|OB|HGM|System, Monitoring, Perinatal|2||N|P||884.2740|1|||||N|N
OB|OB|HGN|Stethoscope, Fetal|1||N|N||884.2900|4|||||N|N
OB|OB|HGO|Monitor, Electroencephalographic, Fetal (And Accessories)|3||N|N||884.2620|2|Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96||||N|N
OB|OB|HGP|Electrode, Circular (Spiral), Scalp And Applicator|2||N|P||884.2675|1|||||N|N
OB|OB|HGS|Catheter, Intrauterine And Introducer|2||N|P||884.2700|1|||||N|N
OB|OB|HGW|Sampler, Blood, Fetal|2||N|P||884.1560|1|||||N|N
OB|OB|HGX|Pump, Breast, Powered|2||N|P||884.5160|1|||||N|N
OB|OB|HGY|Pump, Breast, Non-Powered|1||N|N||884.5150|4|||||N|N
OB|OB|HGZ|Heater, Perineal, Direct Contact|2||N|P||884.5390|4|||||N|N
OB|OB|HHA|Heater, Perineal, Radiant, Non-Contact|2||N|P||884.5390|4|||||N|N
OB|OB|HHD|Pad, Menstrual, Unscented|1||N|N||884.5435|4|||||N|N
OB|OB|HHE|Cup, Menstrual|2||N|P||884.5400|4|||||N|N
OB|OB|HHF|Remover, Intrauterine Device, Contraceptive, Hook-Type|1||N|N||884.4530|4|||||N|N
OB|OB|HHG|Dilator, Cervical, Vibratory|3||N|N||884.4270|2|Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96||||N|N
OB|OB|HHI|System, Abortion, Vacuum|2||N|P||884.5070|1|||||N|N
OB|OB|HHJ|Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic|2||N|Y|M|884.2225|1|||||N|N
OB|OB|HHK|Curette, Suction, Endometrial (And Accessories)|2||N|P||884.1175|1|||||N|N
OB|OB|HHL|Pad, Menstrual, Scented|2||N|P||884.5425|1|||||N|N
OB|OB|HHM|Sound, Uterine|1||N|N||884.4530|4|||||N|N
OB|OB|HHN|Cleidoclast|2||N|P||884.4500|1|||||N|N
OB|OB|HHO|Screw, Fibroid, Gynecological|2||N|P||884.4530|1|||||N|N
OB|OB|HHP|Table, Obstetrical, Manual (And Accessories)|2||N|P||884.4900|1|||||N|N
OB|OB|HHQ|System, Abortion, Metreurynter-Balloon|3||N|N||884.5050|2|Call for PMAs to be filed by 12/26/96 per 61 FR 50709 on 9/27/96||||N|N
OB|OB|HHR|Laser, Surgical, Gynecologic|2||N|Y||884.4550|1|||||N|N
OB|OB|HHS|Insert, Tubal Occlusion|3||N|N||884.5380|2|Call for PMAs 12/30/87 (52 FR 36883 10/1/87))||||Y|N
OB|OB|HHT|Spatula, Cervical, Cytological|2||N|P||884.4530|1|||||N|N
OB|OB|HHW|Pessary, Vaginal|2||N|P||884.3575|1|||||N|N
OB|OB|HHX|Holograph, Fetal, Acoustical|2||N|Y|M|884.2225|1|||||N|N
OB|OB|HIB|Speculum, Vaginal, Nonmetal|2||N|P||884.4530|4|||||N|N
OB|OB|HIC|Speculum, Vaginal, Nonmetal, Fiberoptic|2||N|P||884.4530|1|||||N|N
OB|OB|HIF|Insufflator, Laparoscopic|2||N|Y||884.1730|1|||||N|N
OB|OB|HIG|Insufflator, Hysteroscopic|2||N|Y||884.1700|1|||||N|N
OB|OB|HIH|Hysteroscope (And Accessories)|2||N|Y|M|884.1690|1|||||N|N
OB|OB|HII|Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use|3||N|N||884.5940|2|Call for PMAs to be filed by 7/12/2000 per 65 FR 19834 on 4/13/00||||N|N
OB|OB|HIL|Tampon, Menstrual, Scented, Deodorized|2||N|Y||884.5460|1|||||N|N
OB|OB|HIM|Electrocautery, Endoscopic And Accessories|2||N|N||884.4100|1|||||N|N
OB|OB|HIN|Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)|2||N|N||884.4150|1|||||N|N
OB|OB|HIO|Sampler, Amniotic Fluid (Amniocentesis Tray)|1||N|N||884.1550|4|||||N|N
OB|OB|HIQ|Electrode, Clip, Fetal Scalp (And Applicator)|3||N|N||884.2685|2|Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96||||N|N
OB|OB|HIR|Perineometer|2||N|N||884.1425|1|||||N|N
OB|OB|HIS|Condom|2||N|Y|M|884.5300|1|||||N|N
OB|OB|KNA|Instrument, Manual, Specialized Obstetric-Gynecologic|2||N|N||884.4530|4|||||N|N
OB|OB|KNB|Instrument, Destructive, Fetal, Obstetric|2||N|P||884.4500|1|||||N|N
OB|OB|KNC|Table, Obstetric (And Accessories)|2||N|P||884.4900|1|||||N|N
OB|OB|KND|Heater, Perineal|2||N|P||884.5390|4|||||N|N
OB|OB|KNE|Set, Anesthesia, Obstetric|2||N|P||884.5100|1|||||N|N
OB|OB|KNF|Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)|2||N|P||884.4160|1|||||N|N
OB|OB|KNG|Monitor, Ultrasonic, Fetal|2||N|Y|M|884.2660|1|||||N|N
OB|OB|KNH|Device, Occlusion, Tubal, Contraceptive|3||N|N||884.5380|2|Call for PMAs to be filed by 12/30/87 (52 FR 36883 (10/1/87))||||Y|N
OB|OB|KOH|Instrument, Manual, General Obstetric-Gynecologic|1||N|N||884.4520|4|||||N|N
OB|OB|KXN|Monitor, Cardiac, Fetal|2||N|P||884.2600|1|||||N|N
OB|OB|KXO|Monitor, Pressure, Intrauterine|2||N|P||884.2700|1|||||N|N
OB|OB|KXP|Stent, Vaginal|2||N|P||884.3900|1|||||N|N
OB|OB|KXQ|Vibrator For Therapeutic Use, Genital|2||N|P||884.5960|4|||||N|N
OB|OB|LBX|Pelvimeter, Internal|2||N|P||884.4530|1|||||N|N
OB|OB|LHZ|Viscometer, Mucus, Cervical|1||N|N||884.1040|4|||||N|N
OB|OB|LLW|Laser, Neodymium:Yag For Gynecologic Use|2||N|Y||884.4550|1|||||N|N
OB|OB|LQK|Home Uterine Activity Monitor|2||N|N||884.2730|1|||||N|N
OB|OB|LTZ|Condom With Nonoxynol-9|2||N|Y||884.5310|1|||||N|N
OB|OB|LZL|Micro-Condom|3||N|N||884.5320|2|Call for PMAs to be filed by 9/12/02 per 67 FR 40849 on 6/14/02||||N|N
OB|OB|MBU|Condom, Female, Single-Use|3||N|N||884.5330|2|Class 3 pma||||N|N
OB|OB|MFD|Cannula, Intrauterine Insemination|2||N|N||884.5250|1|||||N|N
OB|OB|MKO|Falloposcope|2||N|N||884.1690|1|||||N|N
OB|OB|MOH|Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use)|2||N|N||884.2730|1|||||N|N
OB|OB|MOK|Vaginoscope And Accessories|2||N|P||884.1630|1|||||N|N
OB|OB|MOL|Condom, Synthetic|2||N|Y||884.5300|1|||||N|N
OB|OB|MPU|Source, Chemiluminescent Light|2||N|N||884.4530|4|||||N|N
OB|OB|MQE|Needle, Assisted Reproduction|2||N|Y||884.6100|1|||||N|N
OB|OB|MQF|Catheter, Assisted Reproduction|2||N|Y||884.6110|1|||||N|N
OB|OB|MQG|Accessory, Assisted Reproduction|2||N|Y||884.6120|1|||||N|N
OB|OB|MQH|Microtools, Assisted Reproduction (Pipettes)|2||N|Y||884.6130|1|||||N|N
OB|OB|MQI|Microtool Fabrication, Assisted Reproduction|2||N|Y||884.6140|1|||||N|N
OB|OB|MQJ|Micromanipulators And Microinjectors, Assisted Reproduction|2||N|Y||884.6150|1|||||N|N
OB|OB|MQK|Labware, Assisted Reproduction|2||N|Y||884.6160|1|||||N|N
OB|OB|MQL|Media, Reproductive|2||N|Y||884.6180|1|||||N|N
OB|OB|MRX|System, Assisted Reproduction Laser|2||N|N||884.6200|1|This system is inteded to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization patients with otherwise poor prognois for successful pregnancy outcome, such as advanced maternal age, prior failed in vitro fertilization procedures, cryopreserved embryos, or abnormal zona pellucida morphology.||||N|N
OB|OB|MSC|Barrier,Std,Oral Sex|2||N|N||884.5300|1|||||N|N
OB|OB|MTW|System,Water,Reproduction,Assisted,And Purification|2||N|Y||884.6170|1|||||N|N
OB|OB|MTX|Microscope And Microscope Accessories,Reproduction,Assisted|1||N|Y||884.6190|4|||||N|N
OB|OB|NBV|Device, Engorgement, Clitoral|2||N|N||884.5970|1|||||N|N
OB|OB|NBZ|Clamp And Cutter, Umbilical|2||N|N||884.4530|1|||||N|N
OB|OB|NHM|Sheet, Recording, Breast Examination|2||N|N||884.2990|1|This recording sheet is intended to for clinicians to mark the locationof a palpable breast lump identified by a clinical breast examination.||||N|N
OB|OB|NKA|System, Documentation, Breast Lesion|2||N|N||884.2990|1|A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam.||||N|N
OB|OB|NKC|Tubing/Tubing With Filter, Insufflation, Laparoscopic|1||N|N||884.1730|4|||||N|N
OB|OB|NMG|Forceps, Biopsy, Gynecological, Reprocessed|2||N|N||884.4530|1|||||N|N
OB|OB|NMH|Laparoscope And Accessories, Gynecologic, Reprocessed|2||N|N||884.1720|1|A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.||||N|N
OB|OB|NMI|Laparoscopic Insufflator And Accessories, Reprocessed|1||N|N||884.1730|1|||||N|N
OB|OB|NNB|Needle, Reproduction, Assisted, Reprocessed|2||N|N||884.6100|1|||||N|N
OB|OB|NRC|Pads, Menstrual, Scented-Deodorized|1||N|N||884.5425|4|A scented or scented deodorized pad is a device made of common cellulosic or synthetic material with an established safety profile.  This does not include menstrual pads treated with added antimicrobial agents.  These are used to absorb menstrual or other vaginal discharge.   These are class i exempt device.||||N|N
OB|OB|NUC|Lubricant, Personal|2||N|N||884.5300|1|This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.  This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.||||N|N
OB|OB|NUQ|Pad, Menstrual, Reusable|1||N|N||884.5435|4|A reusable menstrual pad is made of cellulosic or synthetic material used to   absorb menstrual fluid or other vaginal discharge.||||N|N
OB|OB|NUR|Pad, Interlabial|1||N|N||884.5435|4|A interlabial pad made of cellulosic or synthetic material which is placed over the vaginal introitus to absorb menstrual fluid or other vaginal discharge.||||N|N
OB|OB|NVT|Tubing And Tubing/Filter Fits|1||N|N||884.1700|4|Tubing and tubing/filter fits are used when there is a need to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.|tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation.|tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access|distend the uterine cavity|N|N
OB|OB|NWV|Laparoscopic Accessories, Gynecologic|1||N|N||884.1720|4|Exempt laparoscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc.  A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.|Metal instruments|Part of a system where the accessories advance the working channel of the laparoscope to perform it's function.|Abdominal cavity.|N|N
OB|OB|NWW|Hysteroscope Accessories|1||N|N||884.1690|4|Exempt hysteroscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc.  A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.|Metal instruments|Part of system that advances through the working channel of the hysteroscope to perform it's function.|Uterus|N|N
OB|OB|OBB|Kit, Conception-Assist, Home Use|2||N|N||884.5250|1|The kit is intended for assisted insemination in situations in which low sperm count , sperm immobility, or hostile vaginal environment have been diagnosed.  The kit is used for semen collection and placement into the bowl of a cervical cap as an aid to conception.  It is to be used at home following physician instruction.  The Cap should not be left in place for more than 6 hours.  The kit consists of:  conception (cervical) caps; 3 polyurethane condoms; 24 ovulation predictors; 3 pregnancy test kits; 3 "sperm friendly" moisturizer samples (Pre Lubricant); 1 conception journal; 1 instruction manual; 2 conception wheels (1 in English and 1 in French); 1 medical provider envelope.|The Kit consists of :  conception (cervical) caps (1 for practice insertions); 3 polyurethane condoms; 24 ovulation predictors; 3 pregnancy test kits; 3 "sperm friendly" moisturizer samples (Pre Lubricant); 1 conception journal; 1 instruction manual; 2 conception wheels (1 in English and 1 in French); 1 medical provider envelope.  All device contents have been previously cleared through pre-market notifications; however, the condom and cervical cap have new indications for use (semen collector and collection cap respectively).|During sexual intercouse, sperm is collected in a polyurethane semen collection device (condom).  Immediately thereafter, this sperm is transferred to the bowl of a cervical cap (made of silicone elastomers).  This cap is placed on the cervix for up to 6 hours, so as to improve the chances of insemination.|Sperm, uterine horn, vagina and embryo (if any) have the potential to be affected by this device.|N|N
OB|OB|OBY|Condom, Female, Animal Tissue|3||N|N||884.5330|2|A female condom is a sheath-like device that lines the vaginal wall and is inserted into the vagina prior to the initiation of coitus. It is indicated for contraceptive and prophylactic (preventing the transmission of sexually transmitted diseases) purposes.|A sheath like device made from animal tissue, with retention mechanisms as to stay in place during coitus.|Provides a thin film barrier to sperm and std microorganisms.|vagina|N|N
OB|OB|OHC|Obstetrical Vacuum Delivery Kit|2||N|N||884.4340|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
OB|OB|OHD|Gynecological Laparoscopic Kit|2||N|N||884.1720|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
OB|OB|OHE|Forensic Evidence Sexual Assault Kit|2||N|N||884.1630|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
OB|OB|OHF|Culdocentesis Kit|2||N|N||884.1640|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
OB|OB|OHG|Circumcision Tray|2||N|N||884.4530|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
OB|OB|OHH|Breast Pump Kit|2||N|N||884.5160|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
OB|OB|OHL|Pap Smear Kit|2||N|N||884.4530|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
OB|OB|OHM|Cesarean Section Kit|2||N|N||884.1720|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
OB|OB|OJF|Hysterectomy Kit|2||N|N||884.4530|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
OB|OB|OKU|Emergency Obstetrical Kit|1||N|N||884.4520|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|N|N
OB|OB|OKV|Obstetrical Kit|2||N|N||884.4520|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|N|N
OB|OB|OKW|Seminal Fluid Collection Kit|2||N|N||884.5300|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|N|N
OB|OB|OKX|Obstetrics And Gynecology Trocar Kit|2||N|N||884.1720|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|N|N
OB|OB|OKY|Cytology Kit|2||N|N||884.4530|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|N|N
OB|OB|OKZ|Endometrial Sampling Kit|2||N|N||884.1175|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
OB|OB|OOA|Hemorrhoid Prevention Pressure Wedge|2||N|N||884.5200|4|Provides a counter-pressure to the anus during vaginal delivery.  Intended to prevent the occurrence of and/or stop the progression of hemorrhoids associated with vaginal delivery.|Items include: rigid base with cushioning pad and two lateral straps and two adhesive pads that are applied to the buttocks|Uses a rigid base with cushioning pad applied to the anus held in place by two adhesive strips attached to the buttocks, to provide a counter-pressure to the anus during vaginal delivery|anus, hemorrhoids|N|N
OB|OB|OQY|Intrauterine Tamponade Balloon|2||N|N||884.4530|1|provides temporary control or reduction of postpartum uterine bleeding|The device consists of a catheter with a balloon at the distal end.  The balloon is distended to achieve tamponade or reduction of post partum uterine bleeding.|The clinician passes the balloon through the vagina and cervix into the uterus.  Then, he/she distends the balloon and closely monitors the patient's bleeding.|uterus, cervix, vagina|N|N
OB|OB|OSP|Uterine Electromyographic Monitor|2||N|N||884.2720|1|The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen.  It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton pregnancy.|Monitor with associated electronics and patient skin electrodes.|abdominal EMG surface electrodes that pick up electrical activity from the uterus in labor, electrical signal converted to a monitor tracing.|Maternal abdomen and uterus|N|N
OB|OB|OSV|Insufflator, Endoscopic Vessel Harvesting|2||N|N||884.1730|1|To provide selected flow rates and pressures of co2 gas to separate tissue planes so the saphenous vein or radial artery can be isolated and ligated.|An electronic software controlled gas insufflator which can accept CO2 gas from either a tank or central wall supply.  The gas flow rate and pressure can be adjusted by the user.|The insufflator delivers CO2 gas at a controlled flow rate and pressure to separate tissue planes so the saphenous vein or radial artery can be isolated and ligated.|Leg, saphenous vein or arm, radial artery|N|N
OB|OB|PBH|Embryo Image Assessment System, Assisted Reproduction|2||N|N||884.6195|1|The device will obtain and analyze light microscopy images of developing embryos.  This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing .|Optical imaging system and analysis software|Imaging system that will obtain and analyze light microscopy images of developing embryos.  This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing|Human Embryos|N|N
OB|OB|PBQ|Fixation, Non-Absorbable Or Absorbable,  For Pelvic Use|2||N|N||884.4530|1|Attaching suture or stapling ligaments of the pelvic floor.|non-absorbable or absorbable suture or staple; may include instruments and/or tissue anchoring components as part of a kit|provides mechanism for attachment to and/or from ligaments of the pelvic floor|uterus, vagina, pelvic floor|Y|N
OB|OB|PCF|Sampler, Endocervical|2||N|N||884.1050|1|Obtains tissue samples from the endocervical canal for histological analysis.|handle and sheath with collection tip; collection tip is designed to scrape endocervical canal and collect an endocervical tissue sample|inserted manually through the vaginal and into the endocervix; collection tip scrapes the endocervical canal and collects endocervical tissue sample|cervix|N|N
OB|OB|PEB|Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible|2||N|N||884.5300|1|A personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication.  This device may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.  This device is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive.  This device may also be used during fertility interventions to facilitate entry of diagnostic and therapeutic devices.|Liquid or gel|Coats vaginal and/or penile tissue to reduce friction during sexual activity with or without a condom; is non-toxic to sperm, oocytes, and developing embryos and does not interfere with the fertilization process; lubricates devices used during fertility interventions.|Vagina and/or penis|N|N
OB|OB|PFJ|Catheter, Balloon, Dilation Of Cervical Canal|2||N|N||884.4260|1|Mechanical dilation of the cervical canal for labor.|Catheter with inflatable balloon|Use mechanical force to dilate cervix to prepare for vaginal delivery.|Uterine cervix|N|N
OB|OB|PGK|Cannula, Injector, Uterine, Endometrial Biopsy|2||N|N||884.4530|1|to deliver saline and/or contrast media to complete saline infusion sonohysterography and/or hysterosalpingogram respectively and to obtain endometrial biopsy|cannula that allows injection of saline and/or contrast media and component that collects an endometrial biopsy sample|inserted manually through the vagina and cervix and into the uterus; delivers saline and/or contrast media into the uterus and fallopian tubes, collects endometrial biopsy sample|uterus, fallopian tubes|N|N
OB|OB|PGT|Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar|2||N|N||884.1710|1|to distend the uterus with saline and maintain distension through closed-loop recirculation of filtered distension fluid during diagnostic and operative hysteroscopy.  It is also intended for cutting and coagulation of uterine tissue.|controller that provides bipolar frequency and fluid management through the use of two peristaltic pumps.  Bipolar frequency is delivered to a bipolar electrosurgical resection device.  Fluid management is provided via infusion/aspiration through tubing, sensors, tissue collection container and filter.|a closed-loop system with a preset volume of saline available for use during hysteroscopy.  Fluid is continuously recirculated by pumps from a 3L saline bag, into the uterus, through a tissue trap and a filter and then back to the bag.  Cutting and coagulation are accomplished through use of a bipolar device that has a reciprocating loop electrode.|uterus|N|N
OB|OB|PKN|Dilator, Cervical, Synthetic, Osmotic|2||N|N||884.4260|1|Cervical softening and dilation|Small mass of synthetic material|When placed in the cervical canal, the device absorbs moisture, swells, and exerts radial pressure on the surrounding structures, resulting in mechanical dilation and promotion of cervical ripening.|Cervical canal|N|N
OB|OP|NPB|System, Monitoring, For Progress Of Labor|2||N|N||884.2800|1|This monitoring system for progress of labor provides intrapartum measurement of cervical dilation, fetal head station, and/or other sentinel anatomical markers.  This device is intended to be used adjunctively with other diagnostic information in order to clinically follow the progress of labor.|This monitoring system for progress of labor provides intrapartum measurement of cervical dilation, fetal head station, and/or other sentinel anatomical markers.  This device is intended to be used adjunctively with other diagnostic information in order to clinically follow the progress of labor.|This monitoring system for progress of labor provides intrapartum measurement of cervical dilation, fetal head station, and/or other sentinel anatomical markers.  This device is intended to be used adjunctively with other diagnostic information in order to clinically follow the progress of labor.|This monitoring system for progress of labor provides intrapartum measurement of cervical dilation, fetal head station, and/or other sentinel anatomical markers.  This device is intended to be used adjunctively with other diagnostic information in order to clinically follow the progress of labor.|N|N
OB|SU|OTN|Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator|2||N|N||878.3300|1|Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility|synthetic woven or non-woven fabric of varying material properties (e.g., density, pore size, weave, resorption, etc.); design can be pre-configured or can be a sheet to allow surgeon to cut mesh to desired size and shap|placed under the urethra transvaginally using a transobturator (one vaginal incision and two groin/upper thigh incisions) or retropubic (one vaginal incision and two abdominal incisions) approach; during instances of increased abdominal pressure (e.g., coughing, laughing, sneezing, etc.) the device applies pressure to the urethra to prevent urine leakage|urethra, vagina|Y|N
OB|SU|OTO|Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed|2||N|N||878.3300|1|Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.|synthetic woven or non-woven fabric of varying material properties (e.g., density, pore size, weave, resorption, etc.); design can be pre-configured for specific repair or can be a sheet to allow surgeon to cut mesh to desired size and shape|permanent implant placed transabdominally that provides mechanical support and/or serves as a bridging material for suspending the vaginal apex or uterus from the sacral promontory.|vagina, uterus, sacrum|Y|N
OB|SU|OTP|Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed|2||N|N||878.3300|1|Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed transvaginally|synthetic woven or non-woven fabric of varying material properties (e.g., resorption, density, pore size, weave, etc.); design can be pre-configured for specific repair or can be a sheet to allow surgeon to cut mesh to desired size and shape|permanent implant placed transvaginally that provides mechanical support for weakened tissues of the pelvic floor|vagina, pelvic floor, uterus|Y|N
OB|SU|PAG|Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator|2||N|N||878.3300|1|Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.|Non-synthetic woven or non-woven fabric of varying material properties (e.g., density, pore size, weave, resorption, etc.); design can be pre-configured or can be a sheet to allow surgeon to cut the mesh to desired size and shape.|Placed under the urethra transvaginally using a transobturator (one vaginal incision and two groin/upper thigh incisions) or retropubic (one vaginal incision and two abdominal incisions) approach; during instances of increased abdominal pressure (e.g., coughing, laughing, sneezing, etc.) the device applies pressure to the urethra to prevent urine leakage.|urethra, vagina|Y|N
OB|SU|PAH|Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling|2||N|N||878.3300|1|Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.|Synthetic woven or non-woven fabric of varying material properties (e.g., density, pore size, weave, resorption, etc.); design can be pre-configured or can be a sheet to allow surgeon to cut mesh to desired size and shape.|With a single vaginal incision, the sling is placed under the urethra; during instances of increased abdominal pressure (e.g., coughing, laughing, sneezing, etc.) the device applies pressure to the urethra to prevent urine leakage.|urethra, vagina|Y|N
OB|SU|PAI|Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed|2||N|N||878.3300|1|Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical and uterine prolapse repair completed transvaginally.|Non-synthetic woven or non-woven fabric of varying material properties (e.g., density, pore size, weave, resorption, etc.); design can be pre-configured for specific repair or can be a sheet to allow surgeon to cut the mesh to desired size and shape.|Permanent implant placed transvaginally that provides mechanical support for weakened tissues of the pelvic floor.|vagina, pelvic floor, uterus|Y|N
OB|SU|PAJ|Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed|2||N|N||878.3300|1|Bridging material to attach the vaginal apex or uterus to the sacral promontory; procedures include abdominal sacrocolpopexy, laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy.|Non-synthetic woven or non-woven fabric of varying material properties (e.g., density, pore size, weave, resorption, etc.); design can be pre-configured for specific repair or can be a sheet to allow surgeon to cut the mesh to desired size and shape.|Permanent implant placed transabdominally that provides mechanical support and/or serves as a bridging material for suspending the vaginal apex or uterus to the sacral promontory.|vagina, uterus, sacrum|Y|N
OB||HHY|Prosthesis, Suture, Cerclage|3||N|N|||2|||||N|N
OB||LHD|Device, Fertility Diagnostic, Proceptive|N|6|N|N|||4|||||N|N
OB||LIY|Test, Cervical Mucus Penetration|U|1|N|N|||1|||||N|N
OB||LKF|Cannula, Manipulator/Injector, Uterine|U|1|N|N|||1|||||N|N
OB||LLQ|Cap, Cervical, Contraceptive|3||N|N|||2|||||N|N
OB||LLT|Monitor, Fetal Ph|3||N|N|||3|||||N|N
OB||LLX|Catheter, Sampling, Chorionic Villus|3||N|N|||2|||||N|N
OB||LOB|Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination|3||N|N|||2|||||N|N
OB||LTA|Fluid, Hysteroscopy|3||N|N|||2|||||N|N
OB||LTY|Fluid, Cytological Collection|3||N|N|||2|||||N|N
OB||MCN|Barrier, Absorable, Adhesion|3||N|N|||2|||||N|N
OB||MCP|Stimulator, Fetal, Acoustic|3||N|N|||2|||||N|N
OB||MDG|System, Intrafallopian Cannula|U|1|N|N|||1|||||N|N
OB||MGI|Aspirator, Ultrasonic|3||N|N|||3|||||N|N
OB||MKN|Catheter, Balloon, Transcervical|3||N|N|||2|||||N|N
OB||MLS|Labor And Delivery Kit|N|6|N|N|||7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|N|N
OB||MLT|Kit, Pelvic Exam|N|6|N|N|||7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
OB||MMA|Oximeter, Fetal Pulse|3||N|N|||2|||||N|N
OB||MNA|Device, Semen Analysis|U|1|N|N|||1|||||N|N
OB||MNB|Device, Thermal Ablation, Endometrial|3||N|N|||2|||||N|N
OB||MOV|Catheters, Salpingography|U|1|N|N|||1|||||N|N
OB||MPR|Stent,Bladder,Fetal|f||N|N|||6|||||Y|Y
OB||MPT|Contraception Calculator|U|1|N|N|||1|||||N|N
OB||MWM|Sensor,Electro-Optical(For Cervical Cancer)|3||N|N|||2|An optical detection system for the identification of areas on the cervix likely to contain cancer or precancerous cells.||||N|N
OB||NRZ|Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided|3||N|N|||2|An mr-guided focused ultrasound system is intended to use hifu to ablate soft tissue.  Mr imaging and thermal mapping are used to plan and monitor the use of ultrasound ablation before and during the procedure.||||N|N
OB||OVX|Water Immersion Labor Pool|N|6|N|N|||7|Partial water immersion during labor in hospitals, birth centers and home.|Labor pools/tubs are structures intended to hold water which may be heated.  They may be portable structures which are inflated or easily assembled which are filled using a hose or fixed structures which make use of fixed plumbing.   They may be for single patient use or for multiple users.|The pool/tub provides a water environment in which a pregnant woman may labor.|Area below the head.|N|N
OB||PAS|Rf/Microwave Hyperthermia System, Cancer Treatment|f||N|N|||6|Used in conjunction with radiation therapy for the treatment of cervical carcinoma patients who normally would be treated with combined chemotherapy and radiation but are ineligible for chemotherapy due to patient related factors.|Hyperthermia System|Hyperthermia|Cervical carcinoma|N|N
OB||PKF|D And C Tray|N|6|N|N|||7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm .  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm .  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm .  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm .  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
OP|GU|KYH|Endoscope, Ophthalmic|2||N|P||876.1500|1|||||N|N
OP|GU|MPA|Endoilluminator|2||N|P||876.1500|1|||||N|N
OP|GU|NKZ|Endoilluminator, Reprocessed|2||N|N||876.1500|1|Used intraocularly to provide light into the posterior of the eye during retinal surgery.  Same as product code MPA, except this one is reprocessed.||||N|N
OP|HO|MRH|Pump, Infusion, Ophthalmic|2||N|P||880.5725|1|||||N|N
OP|OP|FCT|Headlight, Fiberoptic Focusing|2||N|P||886.4335|4|||||N|N
OP|OP|FSR|Light, Headband, Surgical|2||N|P||886.4335|4|||||N|N
OP|OP|FTZ|Locator, Magnetic|1||Y|N||886.4445|4|||||N|N
OP|OP|HIT|Tester, Color Vision|1||Y|N||886.1170|4|||||N|N
OP|OP|HIW|Anomaloscope|1||N|N||886.1070|4|||||N|N
OP|OP|HIX|Maxwell Spot, Ac-Powered|1||N|N||886.1435|4|||||N|N
OP|OP|HIY|Brush, Haidinger, (Including Macular Integrity)|1||N|N||886.1090|4|||||N|N
OP|OP|HJA|Photokeratoscope|1||N|N||886.1350|4|||||N|N
OP|OP|HJB|Instrument, Measuring, Corneal Radius|1||N|N||886.1450|4|||||N|N
OP|OP|HJC|Esthesiometer, Ocular|1||N|N||886.1040|4|||||N|N
OP|OP|HJD|Illuminator, Color Vision Plate|1||N|N||886.1160|4|||||N|N
OP|OP|HJF|Magnifier, Hand-Held, Low-Vision|1||Y|N||886.5540|4|||||N|N
OP|OP|HJG|System, Reading, Television, Closed-Circuit|1||N|N||886.5820|4|||||N|N
OP|OP|HJH|Loupe, Binocular, Low Power|1||Y|N||886.5120|4|||||N|N
OP|OP|HJI|Lens, Fundus, Hruby, Diagnostic|1||Y|N||886.1395|4|||||N|N
OP|OP|HJJ|Lens, Fresnel, Flexible, Diagnostic|1||Y|N||886.1390|4|||||N|N
OP|OP|HJK|Lens, Contact, Polymethylmethacrylate, Diagnostic|2||N|P||886.1385|1|||||N|N
OP|OP|HJL|Lens, Condensing, Diagnostic|1||Y|N||886.1380|4|||||N|N
OP|OP|HJM|Transilluminator, Ac-Powered|2||N|P||886.1945|4|||||N|N
OP|OP|HJN|Transilluminator, Battery-Powered|1||N|N||886.1945|4|||||N|N
OP|OP|HJO|Biomicroscope, Slit-Lamp, Ac-Powered|2||N|Y|M|886.1850|1|||||N|N
OP|OP|HJQ|Stereoscope, Ac-Powered|1||N|N||886.1870|4|||||N|N
OP|OP|HJR|Stereoscope, Battery-Powered|1||Y|N||886.1870|4|||||N|N
OP|OP|HJS|Test, Spectacle Dissociation, Ac-Powered (Lancaster)|1||N|N||886.1910|4|||||N|N
OP|OP|HJT|Haploscope|1||N|N||886.1340|4|||||N|N
OP|OP|HJW|Adaptometer (Biophotometer)|1||N|N||886.1050|4|||||N|N
OP|OP|HJX|Reader, Prism, Ophthalmic|1||Y|N||886.5810|4|||||N|N
OP|OP|HJY|Reader, Bar, Ophthalmic|1||Y|N||886.5800|4|||||N|N
OP|OP|HJZ|Crutch, Ptosis|1||Y|N||886.5600|4|||||N|N
OP|OP|HKB|Telescope, Hand-Held, Low-Vision|1||Y|N||886.5870|4|||||N|N
OP|OP|HKC|Spectacle Microscope, Low-Vision|1||Y|N||886.5540|4|||||N|N
OP|OP|HKD|Tape, Nystagmus|1||Y|N||886.1905|4|||||N|N
OP|OP|HKF|Mirror, Headband, Ophthalmic|1||N|N||886.1500|4|||||N|N
OP|OP|HKG|Fornixscope|1||Y|N||886.1320|4|||||N|N
OP|OP|HKI|Camera, Ophthalmic, Ac-Powered|2||N|P||886.1120|1|||||N|N
OP|OP|HKK|Telescope, Spectacle, Low-Vision|1||Y|N||886.5870|4|||||N|N
OP|OP|HKL|Retinoscope, Ac-Powered|2||N|Y|M|886.1780|1|||||N|N
OP|OP|HKM|Retinoscope, Battery-Powered|1||Y|N||886.1780|4|||||N|N
OP|OP|HKN|Refractor, Manual, Non-Powered, Including Phoropter|1||Y|N||886.1770|4|||||N|N
OP|OP|HKO|Refractometer, Ophthalmic|1||N|N||886.1760|4|||||N|N
OP|OP|HKP|Instrument, Vitreous Aspiration And Cutting, Battery-Powered|2||N|Y|M|886.4150|1|||||N|N
OP|OP|HKQ|Prism, Rotary, Ophthalmic|1||Y|N||886.1665|4|||||N|N
OP|OP|HKR|Lens, Maddox|1||Y|N||886.1400|4|||||N|N
OP|OP|HKS|Prism, Gonioscopic|1||N|N||886.1660|4|||||N|N
OP|OP|HKT|Prism, Fresnel, Ophthalmic|1||Y|N||886.1655|4|||||N|N
OP|OP|HKW|Prism, Bar, Ophthalmic|1||Y|N||886.1650|4|||||N|N
OP|OP|HKX|Tonometer, Ac-Powered|2||N|N||886.1930|1|||||N|N
OP|OP|HKY|Tonometer, Manual|2||N|P||886.1930|1|||||N|N
OP|OP|HKZ|Sterilizer, Tonometer|1||N|N||886.1940|4|||||N|N
OP|OP|HLA|Calibrator, Tonometer|2||N|P||886.1930|1|||||N|N
OP|OP|HLC|Instrument, Measuring, Stereopsis|1||Y|N||886.1460|4|||||N|N
OP|OP|HLD|Engine, Trephine, Accessories, Gas-Powered|1||N|Y|M|886.4070|4|||||N|N
OP|OP|HLE|Ruler, Nearpoint (Punctometer)|1||Y|N||886.1790|4|||||N|N
OP|OP|HLF|Device, Measuring, Lens Radius, Ophthalmic|1||N|N||886.1430|4|||||N|N
OP|OP|HLG|Pupillometer, Ac-Powered|1||N|N||886.1700|4|||||N|N
OP|OP|HLH|Pupillometer, Manual|1||Y|N||886.1700|4|||||N|N
OP|OP|HLI|Ophthalmoscope, Ac-Powered|2||N|Y|M|886.1570|1|||||N|N
OP|OP|HLJ|Ophthalmoscope, Battery-Powered|2||N|Y|M|886.1570|1|||||N|N
OP|OP|HLK|Screen, Tangent, Target, Battery-Powered|1||Y|N||886.1810|4|||||N|N
OP|OP|HLL|Monitor, Eye Movement|2||N|P||886.1510|1|||||N|N
OP|OP|HLM|Instrument, Measuring, Lens, Ac-Powered|1||N|N||886.1425|4|||||N|N
OP|OP|HLN|Gauge, Lens, Ophthalmic|1||N|N||886.1420|4|||||N|N
OP|OP|HLO|Test, Spectacle Dissociation, Battery-Powered (Lancaster)|1||Y|N||886.1910|4|||||N|N
OP|OP|HLP|Target, Fusion And Stereoscopic|1||Y|N||886.1880|4|||||N|N
OP|OP|HLQ|Keratoscope, Ac-Powered|1||N|N||886.1350|4|||||N|N
OP|OP|HLR|Keratoscope, Battery-Powered|1||Y|N||886.1350|4|||||N|N
OP|OP|HLS|Exophthalmometer|1||N|N||886.1270|4|||||N|N
OP|OP|HLT|Preamplifier, Ac-Powered, Ophthalmic|2||N|P||886.1640|1|||||N|N
OP|OP|HLW|Preamplifier, Battery-Powered, Ophthalmic|2||N|P||886.1640|1|||||N|N
OP|OP|HLX|Photostimulator, Ac-Powered|2||N|P||886.1630|1|||||N|N
OP|OP|HLZ|Electrode, Corneal|2||N|P||886.1220|1|||||N|N
OP|OP|HMC|Monitor, Eye Movement, Diagnostic|2||N|P||886.1510|1|||||N|N
OP|OP|HMD|Chair, Ophthalmic, Manual|1||Y|N||886.1140|4|||||N|N
OP|OP|HME|Chair, Ophthalmic, Ac-Powered|1||N|N||886.1140|4|||||N|N
OP|OP|HMF|Stand, Instrument, Ac-Powered, Ophthalmic|1||N|N||886.1860|4|||||N|N
OP|OP|HMG|Stand, Instrument, Ophthalmic, Non-Powered|1||N|N||886.1860|4|||||N|N
OP|OP|HMH|Rack, Skiascopic|1||N|N||886.1750|4|||||N|N
OP|OP|HMJ|Screen, Tangent, Projection, Battery-Powered|1||Y|N||886.1810|4|||||N|N
OP|OP|HMK|Euthyscope, Ac-Powered|2||N|P||886.1250|4|||||N|N
OP|OP|HML|Euthyscope, Battery-Powered|1||N|N||886.1250|4|||||N|N
OP|OP|HMM|Distometer|1||Y|N||886.1190|4|||||N|N
OP|OP|HMQ|Marker, Sclera|1||N|N||886.4570|4|||||N|N
OP|OP|HMR|Marker, Ocular|1||N|N||886.4570|4|||||N|N
OP|OP|HMS|Drum, Eye Knife Test|1||Y|N||886.4230|4|||||N|N
OP|OP|HMX|Cannula, Ophthalmic|1||N|N||886.4350|4|||||N|N
OP|OP|HMY|Keratome, Battery-Powered|1||N|Y|M|886.4370|1|||||N|N
OP|OP|HMZ|Trabeculotome|1||N|N||886.4350|4|||||N|N
OP|OP|HNA|Spud, Ophthalmic|1||N|N||886.4350|4|||||N|N
OP|OP|HNB|Spoon, Ophthalmic|1||N|N||886.4350|4|||||N|N
OP|OP|HNC|Specula, Ophthalmic|1||N|N||886.4350|4|||||N|N
OP|OP|HND|Spatula, Ophthalmic|1||N|N||886.4350|4|||||N|N
OP|OP|HNE|Snare, Enucleating|1||N|N||886.4350|4|||||N|N
OP|OP|HNF|Scissors, Ophthalmic|1||N|N||886.4350|4|||||N|N
OP|OP|HNG|Rongeur, Lachrymal Sac|1||N|N||886.4350|4|||||N|N
OP|OP|HNH|Ring, Ophthalmic (Flieringa)|1||N|N||886.4350|4|||||N|N
OP|OP|HNI|Retractor, Ophthalmic|1||N|N||886.4350|4|||||N|N
OP|OP|HNJ|Punch, Corneo-Scleral|1||N|N||886.4350|4|||||N|N
OP|OP|HNK|Probe, Trabeculotomy|1||N|N||886.4350|4|||||N|N
OP|OP|HNL|Probe, Lachrymal|1||N|N||886.4350|4|||||N|N
OP|OP|HNM|Needle, Ophthalmic Suturing|1||N|N||886.4350|4|||||N|N
OP|OP|HNN|Knife, Ophthalmic|1||N|N||886.4350|4|||||N|N
OP|OP|HNO|Keratome, Ac-Powered|1||N|Y|M|886.4370|1|||||N|N
OP|OP|HNP|Introducer, Sphere|1||N|N||886.4350|4|||||N|N
OP|OP|HNQ|Hook, Ophthalmic|1||N|N||886.4350|4|||||N|N
OP|OP|HNR|Forceps, Ophthalmic|1||N|N||886.4350|4|||||N|N
OP|OP|HNS|Expressor|1||N|N||886.4350|4|||||N|N
OP|OP|HNT|Erisophake|1||N|N||886.4350|4|||||N|N
OP|OP|HNW|Dilator, Lachrymal|1||N|N||886.4350|4|||||N|N
OP|OP|HNX|Depressor, Orbital|1||N|N||886.4350|4|||||N|N
OP|OP|HNY|Cystotome|1||N|N||886.4350|4|||||N|N
OP|OP|HNZ|Curette, Ophthalmic|1||N|N||886.4350|4|||||N|N
OP|OP|HOA|Compressor, Orbital|1||N|N||886.4350|4|||||N|N
OP|OP|HOB|Clamp, Muscle, Ophthalmic|1||N|N||886.4350|4|||||N|N
OP|OP|HOC|Clip, Iris Retractor|1||N|N||886.4350|4|||||N|N
OP|OP|HOD|Clamp, Eyelid, Ophthalmic|1||N|N||886.4350|4|||||N|N
OP|OP|HOE|Caliper, Ophthalmic|1||N|N||886.4350|4|||||N|N
OP|OP|HOF|Burr, Corneal, Manual|1||N|N||886.4350|4|||||N|N
OP|OP|HOG|Burr, Corneal, Battery-Powered|1||N|Y|M|886.4070|4|||||N|N
OP|OP|HOH|Spectacle, Operating (Loupe), Ophthalmic|1||Y|N||886.4770|4|||||N|N
OP|OP|HOI|Spectacle, Magnifying|1||N|N||886.5840|4|||||N|N
OP|OP|HOJ|Screen, Tangent, Target|1||N|N||886.1810|4|||||N|N
OP|OP|HOK|Screen, Tangent, Projection, Ac-Powered|1||N|N||886.1810|4|||||N|N
OP|OP|HOL|Screen, Tangent, Felt (Campimeter)|1||N|N||886.1810|4|||||N|N
OP|OP|HOM|Screen, Tangent, Ac-Powered (Campimeter)|1||N|N||886.1810|4|||||N|N
OP|OP|HON|Perimeter, Manual|1||Y|N||886.1605|4|||||N|N
OP|OP|HOO|Perimeter, Ac-Powered|1||N|N||886.1605|4|||||N|N
OP|OP|HOP|Campimeter, Stereo, Battery-Powered|1||Y|N||886.1810|4|||||N|N
OP|OP|HOQ|Grid, Amsler|1||Y|N||886.1330|4|||||N|N
OP|OP|HOR|Simulatan (Including Crossed Cylinder)|1||Y|N||886.1840|4|||||N|N
OP|OP|HOS|Projector, Ophthalmic|1||N|N||886.1680|4|||||N|N
OP|OP|HOT|Aid, Vision Image Intensification|1||Y|N||886.5910|4|||||N|N
OP|OP|HOW|Drum, Opticokinetic|1||Y|N||886.1200|4|||||N|N
OP|OP|HOX|Chart, Visual Acuity|1||Y|N||886.1150|4|||||N|N
OP|OP|HOY|Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)|1||Y|N||886.4750|4|||||N|N
OP|OP|HOZ|Sponge, Ophthalmic|2||N|P||886.4790|4|||||N|N
OP|OP|HPA|Frame, Trial, Ophthalmic|1||Y|N||886.1415|4|||||N|N
OP|OP|HPB|Clip, Lens, Trial, Ophthalmic|1||N|N||886.1410|4|||||N|N
OP|OP|HPC|Set, Lens, Trial, Ophthalmic|1||N|N||886.1405|4|||||N|N
OP|OP|HPD|Lens, Bagolini|1||Y|N||886.1375|4|||||N|N
OP|OP|HPE|Aid, Vision, Optical, Battery-Powered|1||Y|N||886.5915|4|||||N|N
OP|OP|HPF|Aid, Vision, Electronic, Ac-Powered|1||N|N||886.5900|4|||||N|N
OP|OP|HPG|Aid, Vision, Electronic, Battery-Powered|1||N|N||886.5900|4|||||N|N
OP|OP|HPI|Aid, Vision, Optical, Ac-Powered|1||N|N||886.5915|4|||||N|N
OP|OP|HPJ|Instrument, Visual Field, Laser|2||N|P||886.1360|1|||||N|N
OP|OP|HPK|Tonograph|2||N|P||886.1930|1|||||N|N
OP|OP|HPL|Device, Fixation, Ac-Powered, Ophthalmic|1||N|N||886.1290|4|A fixation device is an AC-powered device intended for use as a fixation target for the patient during ophthalmologic examination.  The patient directs his or her gaze so that the visual image of the object falls on the fovea centralis (the center of the macular retina of the eye.)||||N|N
OP|OP|HPM|Locator, Metal, Electronic|2||N|P||886.4400|4|||||N|N
OP|OP|HPN|Magnet, Permanent|1||Y|N||886.4445|4|||||N|N
OP|OP|HPO|Magnet, Ac-Powered|2||N|P||886.4440|4|||||N|N
OP|OP|HPP|Headlamp, Operating, Battery-Operated|1||N|N||886.4335|4|||||N|N
OP|OP|HPQ|Headlamp, Operating, Ac-Powered|2||N|P||886.4335|4|||||N|N
OP|OP|HPS|Unit, Cryophthalmic|2||N|P||886.4170|1|||||N|N
OP|OP|HPT|Perimeter, Automatic, Ac-Powered|1||N|N||886.1605|4|||||N|N
OP|OP|HPW|Probe And Counter, Isotope, For Phosphorus 32|2||N|P||886.1670|1|||||N|N
OP|OP|HPY|Unit, Electrolysis, Battery-Powered, Ophthalmic|1||N|N||886.4250|4|||||N|N
OP|OP|HPZ|Implant, Eye Sphere|2||N|N||886.3320|1|||||Y|N
OP|OP|HQA|Unit, Cryotherapy, Ophthalmic|2||N|P||886.4170|1|||||N|N
OP|OP|HQB|Photocoagulator And Accessories|2||N|P||886.4690|1|||||N|N
OP|OP|HQC|Unit, Phacofragmentation|2||N|Y|M|886.4670|1|||||N|N
OP|OP|HQD|Lens, Contact (Other Material) - Daily|2||N|Y||886.5916|1|||||N|N
OP|OP|HQE|Instrument, Vitreous Aspiration And Cutting, Ac-Powered|2||N|Y|M|886.4150|1|||||N|N
OP|OP|HQF|Laser, Ophthalmic|2||N|Y||886.4390|1|||||N|N
OP|OP|HQG|Lens, Spectacle, Non-Custom (Prescription)|1||N|N||886.5844|4|||||N|N
OP|OP|HQH|Eye, Artificial, Non-Custom|1||N|N||886.3200|4|||||N|N
OP|OP|HQJ|Implant, Absorbable, (Scleral Buckling Methods)|2||N|N||886.3300|1|||||Y|N
OP|OP|HQL|Intraocular Lens|3||N|N||886.3600|2|||||Y|N
OP|OP|HQM|Keratoprosthesis, Permanent Implant|2||N|N||886.3400|1|||||Y|N
OP|OP|HQN|Conformer, Ophthalmic|2||N|N||886.3130|4|||||N|N
OP|OP|HQO|Unit, Cautery, Thermal, Ac-Powered|2||N|P||886.4115|1|||||N|N
OP|OP|HQP|Unit, Cautery, Thermal, Battery-Powered|2||N|P||886.4115|1|||||N|N
OP|OP|HQQ|Apparatus, Cautery, Radiofrequency, Battery-Powered|2||N|P||886.4100|1|||||N|N
OP|OP|HQR|Apparatus, Cautery, Radiofrequency, Ac-Powered|2||N|P||886.4100|1|||||N|N
OP|OP|HQS|Burr, Corneal, Ac-Powered|1||N|Y|M|886.4070|4|||||N|N
OP|OP|HQT|Shell, Scleral|2||N|N||886.3800|4|||||Y|N
OP|OP|HQW|Clip, Tantalum, Ophthalmic|2||N|N||886.3100|4|||||Y|N
OP|OP|HQX|Implant, Orbital, Extra-Ocular|2||N|N||886.3340|1|||||Y|N
OP|OP|HQY|Sunglasses (Non-Prescription Including Photosensitive)|1||N|N||886.5850|4|||||N|N
OP|OP|HQZ|Frame, Spectacle|1||N|N||886.5842|4|||||N|N
OP|OP|HRC|Sterilizer, Soft-Lens, Thermal, Battery-Powered|2||N|P||886.5928|1|||||N|N
OP|OP|HRD|Sterilizer, Soft-Lens, Thermal, Ac-Powered|2||N|P||886.5928|1|||||N|N
OP|OP|HRE|Cabinet, Instrument, Ac-Powered, Ophthalmic|1||N|N||886.1860|4|||||N|N
OP|OP|HRF|Engine, Trephine, Accessories, Battery-Powered|1||N|Y|M|886.4070|4|||||N|N
OP|OP|HRG|Engine, Trephine, Accessories, Ac-Powered|1||N|Y|M|886.4070|4|||||N|N
OP|OP|HRH|Trephine, Manual, Ophthalmic|1||N|N||886.4350|4|||||N|N
OP|OP|HRI|Pupillograph|1||N|N||886.1690|4|||||N|N
OP|OP|HRJ|Table, Instrument, Powered, Ophthalmic|1||N|N||886.4855|4|||||N|N
OP|OP|HRK|Table, Instrument, Manual, Ophthalmic|1||Y|N||886.4855|4|||||N|N
OP|OP|HRL|Unit, Beta, Radiation, Ophthalmic|2||N|P||886.5100|1|||||N|N
OP|OP|HRN|Unit, Cryophthalmic, Ac-Powered|2||N|P||886.4170|1|||||N|N
OP|OP|HRO|Unit, Electrolysis, Ac-Powered, Ophthalmic|2||N|P||886.4250|4|||||N|N
OP|OP|HRP|Pen, Marking, Surgical|1||N|N||886.4570|4|||||N|N
OP|OP|KYB|Lens, Guide, Intraocular|1||N|Y|M|886.4300|4|||||N|N
OP|OP|KYD|Strip, Schirmer|1||N|N||886.1800|4|||||N|N
OP|OP|KYE|Inserter/Remover Contact Lens|1||N|N||886.5420|4|||||N|N
OP|OP|KYF|Implant, Eye Valve|2||N|N||886.3920|1|||||Y|N
OP|OP|KYG|Device, Irrigation, Ocular Surgery|1||N|N||886.4360|4|||||N|N
OP|OP|LCC|Applicator, Ocular Pressure|2||N|P||886.4610|1|||||N|N
OP|OP|LPL|Lenses, Soft Contact, Daily Wear|2||N|Y||886.5925|1|||||N|N
OP|OP|LPM|Lenses, Soft Contact, Extended Wear|3||N|N||886.5925|2|||||N|N
OP|OP|LPN|Accessories, Soft Lens Products|2||N|Y||886.5928|1|||||N|N
OP|OP|LPO|Gases Used Within Eye To Place Pressure On Detached Retina|3||N|N||886.4270|2|||||N|N
OP|OP|LQJ|Lens, Surgical, Laser, Accesssory, Ophthalmic Laser|2||N|Y||886.4390|1|||||N|N
OP|OP|LRX|Case, Contact Lens|2||N|Y||886.5928|1|||||N|N
OP|OP|LWL|Fluid, Intraocular|3||N|N||886.4275|2|||||N|N
OP|OP|LXS|Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla|2||N|Y||886.4392|1|||||N|N
OP|OP|LYL|Accessories, Solution, Ultrasonic Cleaners For Lenses|2||N|Y||886.5928|1|||||N|N
OP|OP|LZP|Aid, Surgical, Viscoelastic|3||N|N||886.4275|2|||||N|N
OP|OP|MFK|Lens, Multifocal Intraocular|3||N|N||886.3600|2|||||N|N
OP|OP|MJP|Lens, Intraocular, Toric Optics|3||N|N||886.3600|2|||||Y|N
OP|OP|MLP|Keratoprosthesis, Temporary Implant, Surgical Use|2||N|Y||886.3400|1|||||Y|N
OP|OP|MLZ|Vitrectomy, Instrument Cutter|2||N|Y|M|886.4150|1|||||N|N
OP|OP|MMC|Dilator, Expansive Iris (Accessory)|2||N|Y|M|886.4150|1|||||N|N
OP|OP|MMF|Photorefractor|2||N|P||886.1120|4|||||N|N
OP|OP|MMQ|Topographer, Corneal, Ac-Powered|1||N|N||886.1350|4|||||N|N
OP|OP|MOE|Collagen Corneal Shield|1||Y|N||886.4750|4|||||N|N
OP|OP|MQU|Ocular Peg|2||N|N||886.3320|1|||||Y|N
OP|OP|MRC|Products, Contact Lens Care, Rigid Gas Permeable|2||N|Y||886.5918|1|||||N|N
OP|OP|MSR|Tubing, Replacement, Phacofragmentation Unit|2||N|P||886.4150|1|||||N|N
OP|OP|MSS|Folders And Injectors, Intraocular Lens (Iol)|1||N|Y||886.4300|1|||||N|N
OP|OP|MTZ|Wrap, Implant, Orbital|2||N|N||886.3320|1|||||Y|N
OP|OP|MUS|Fluidic, Phacoemulsification/Phacofragmentation|2||N|P||886.4670|1|||||N|N
OP|OP|MUW|Lens, Contact (Orthokeratology)|2||N|N||886.5916|1|||||N|N
OP|OP|MVN|Lens, Contact, (Disposable)|2||N|Y||886.5925|1|||||N|N
OP|OP|MWL|Lens,Contact(Rigid Gas Permeable)-Extended Wear|3||N|N||886.5916|2|||||N|N
OP|OP|MXK|Device,Analysis,Anterior Segment|2||N|P||886.1850|1|||||N|N
OP|OP|MXO|Laser,System,Phacolysis|2||N|P||886.4670|1|||||N|N
OP|OP|MXY|Cannula,Ophthalmic,Posterior Capsular Polishing,Polyvinyl Acetal|1||N|N||886.4350|4|||||N|N
OP|OP|MYC|Ophthalmoscope,Laser,Scanning|2||N|Y||886.1570|1|||||N|N
OP|OP|MYD|Keratome,Water Jet|1||N|Y||886.4370|1|||||N|N
OP|OP|MZD|System,In-Office Tinting,Contact Lenses|2||N|Y||886.5925|1|||||N|N
OP|OP|NAA|Lens,Intraocular,Accommodative|3||N|N||886.3600|2|||||Y|N
OP|OP|NAI|Lens,Prescription,Color Deficiency|1||N|N||886.5844|4|||||N|N
OP|OP|NCE|Injector, Capsular Tension Ring|1||N|Y||886.4300|1|||||N|N
OP|OP|NCF|Aberrometer, Ophthalmic|1||N|N||886.1760|4|||||N|N
OP|OP|NCK|Button, Iris, Eye, Artificial|1||N|N||886.3200|4|||||N|N
OP|OP|NCR|Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered|2||N|P||886.4100|1|||||N|N
OP|OP|NCZ|Lens, Contact, For Color Vision Deficiency|2||N|N||886.5925|1|||||N|N
OP|OP|NFD|Selector, Color, Spectacle, Lens, Tint|1||N|N||886.1160|4|||||N|N
OP|OP|NFM|Expander, Tissue, Orbital|2||N|N||886.3320|1|||||Y|N
OP|OP|NGY|Cannula, Trocar, Ophthalmic|1||N|N||886.4350|4|The trocar/cannula set is a manual surgical instrument intended for use as single-use, disposable cannula system for establishing an entry site conduit for passing ophthalmic instruments used to perform posterior ophthalmic surgical procedures.||||N|N
OP|OP|NIC|Lens, Contact, For Reading Discomfort|2||N|N||886.5925|1|This lens is indicated for daily wear for the correction of refractive ametropia in persons with non-diseased eyes. This lens may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.||||N|N
OP|OP|NIZ|Lens, Iris Reconstruction|3||N|N||886.3600|2|An iris reconstruction lens is an intraocular lens (IOL) which is used in patients with partial  or complete loss of the iris induced by trauma or congenital defect. The IOL serves as an artificial iris and lens,  reducing light sensitivity and/or glare disability. The device is implanted in the capsular bag or sulcus for the correction  of aphakia and aniridia.||||Y|N
OP|OP|NJG|Flasher, Afterimage, Ophthalmic|2||N|P||886.1300|1|||||N|N
OP|OP|NJH|Lens, Spectacle (Prescription), For Reading Discomfort|1||N|N||886.5844|4|Colored spectacle lenses may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.||||N|N
OP|OP|NJJ|Tonometer, Analyzer, Ocular Blood Flow|2||N|P||886.1930|1|Tonometry for measuring and recording intraocular pressures and intraocular pulse amplitudes, pulsatile ocular blood flow, pulsatile ocular blood volume, pulsatility index equivalent.  Description of why current product c lassificaiton name/product code will not suffice: This device measures intraocular pressure, which is what a tonometer does.  However, because it can measure the small changes in pressure caused by the blood pressure pulse in the ocular arterial vessels, it is also capable of measuring and calculating parameters associated with the ocular blood flow, including intraocular pressure pulse amplitude, pulsatile ocular blood flow, and pulsatile ocular blood volume.||||N|N
OP|OP|NKX|Needle, Phacoemulsification, Reprocessed|2||N|N||886.4670|1|Needle for phacoemulsification device to remove cataractous lens.  Same as needle for main phacoemulsification device and un-reprocessed needle with product code HQC, except this is a "reprocessed" needle.  The Phacoemulsification device is NOT reprocessed, just the needle.||||N|N
OP|OP|NKY|Blade, Keratome, Reprocessed|1||N|N||886.4370|1|Blade for keratome to make flap in cornea for LASIK refractive surgery.  Same as previously cleared blade for keratomes, product codes HMY and HNO, except this is reprocessed.||||N|N
OP|OP|NLA|Knife, Ophthalmic, Reprocessed|1||N|N||886.4350|1|Used for cutting soft tissue in or around the eye.  Surgical knife same as product code HNN, except this one is reprocessed.||||N|N
OP|OP|NOG|Topographer, Corneal, Battery Powered|1||Y|N||886.1350|4|external aesthetic restoration prosthesis||||N|N
OP|OP|NOH|Photokeratoscope, Battery Powered|1||Y|N||886.1350|4|external aesthetic restoration prosthesis||||N|N
OP|OP|NOI|Stand, Instrument, Ophthalmic, Battery Powered|1||Y|N||886.1860|4|AC-powered or non-powered device intended to store ophthalmic instruments in a readily accessible position.||||N|N
OP|OP|NQB|Conformer, Ophthalmic, Biological Tissue|2||N|N||886.3130|4|The ophthalmic conformer with molded plastic and biological tissue insert is introduced temporarily between the eyeball and eyelid to maintain space in the orbital cavity, prevent closure or adhesions during the healing process following surgery, and enables positioning of biological tissue to the ocular surface without the need for sutures.||||Y|N
OP|OP|NQE|Microscope, Specular|2||N|P||886.1850|1|Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.||||N|N
OP|OP|NUU|Lens, Contact, Orthokeratology, Overnight|3||N|N||886.5916|2|TEMPORARY REDUCTION OF MYOPIA OR REFRACTIVE ERROR.||||N|N
OP|OP|NVB|Intraocular, Pressure Measuring Device|3||N|N||886.4280|2|MANUAL OR AC POWERED DEVICE INTENDED TO MEASURE INTRAOCULAR PRESSURE. INTENDED FOR USE IN THE DIAGNOSIS OF GLAUCOMA.||||N|N
OP|OP|NXM|Prosthesis, Eyelid Spacer/Graft, Biologic|2||N|N||886.3130|4|For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid.|Lyophilized sheets of SIS cut to various sizes|Natural collagen matrix which reinforces tissue and promotes cellular ingrowth|Eyelid, eyelid area|Y|N
OP|OP|NXR|Fixation, Vision Training, Binocular|1||N|N||886.1290|4|To improve speed, accuracy, and coordination of binocular eye movements and changes of accommodation.  To treat poor accommodation and vergence facility, convergence insufficiency, and accommodative lag.|Lights are spaced along a rod or positioned two-dimensionally on a screen.  Various materials are used for the rod or screen.|Multiple fixation targets move or alternate in preprogrammed sequences.|The eye|N|N
OP|OP|NYK|Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)|2||N|N||886.1385|1|Pmma diagnostic contact lens ophthalmodynamometer is intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis of intraocular abnormalities.  The device is indicated for examination of the ocular fundus, vitreous and retinal structures, while manually applying force to the eye with the contact lens.  The device measures and displays the amount of force that is applied to the eye.|The contact lens consists of a curved shell of acrylic plastic (PMMA), which is adapted with electronic sensors for measurement of pressure applied to the eye.  The pressure values are displayed on a LCD display.|The examination PMMA contact lens is adapted with electronic sensors for measurement of pressure applied to the eye. The pressure values are displayed on a LCD display.|Eye|N|N
OP|OP|OBO|Tomography, Optical Coherence|2||N|N||886.1570|1|Viewing, imaging, measurement, and analysis of ocular structures.  Diagnostic device to aid in the detection and management of various ocular diseases.|Computerized imaging device consisting of light sources and beam delivery and scanning optics.|Cross sectional tomograms of ocular structures are obtained using non-invasive, non-contact, low-coherence optical interferometry.|Eye.|N|N
OP|OP|OHW|Burr, Corneal, Battery Powered, Rust Ring Removal|1||N|N||886.4070|4|A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye and is class I exempt when intended only for rust ring removal.|A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye and is class I exempt when intended only for rust ring removal.|A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye and is class I exempt when intended only for rust ring removal.|A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye and is class I exempt when intended only for rust ring removal.|N|N
OP|OP|OHX|Burr, Corneal, Ac-Powered, Rust Ring Removal|1||N|N||886.4070|4|A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye and is class I exempt when intended only for rust ring removal.|A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye and is class I exempt when intended only for rust ring removal.|A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye and is class I exempt when intended only for rust ring removal.|A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye and is class I exempt when intended only for rust ring removal.|N|N
OP|OP|OJK|Eye Tray|2||N|N||886.4790|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
OP|OP|OOE|Ophthalmic Femtosecond Laser|2||N|N||886.4390|1|Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.|The device consists of a laser console, a computer with grahic user interface, a beam delivery system that positions and focuses the laser beam, and a patient interface system that flattens the cornea and holds the patient's eye still during the surgical procedure.|A Nd:glass solid state laser generates sub-picosecond pulses at a 15 kHz repetition rate.  The beam is focused at high convergence to a spot diameter <6 microns at the target location.  Tissue is vaporized in a very small region at the focal point.  A computer-controlled 3-dimensional scanning system positions the beam with micron-scale accuracy.|Anterior lens capsule of the eye.|N|N
OP|OP|OPT|Infrared Hematoma Detector|2||N|N||882.1935|1|To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.|This is a standard infrared handheld laser that is scanned across the scalp.  The information is transmitted to a handheld Personal Digital Assistant that displays Optical Density measurements|Use of low level infrared laser radiation to detect hemoglobin concentration which relates to presence of a hemotoma.|To be used on the head.  The testing divides the head into 8 sections four on the left side and the corresponding 4 sites on the right side.|N|N
OP|OP|ORZ|Eyelid Thermal Pulsation System|2||N|N||886.5200|1|Therapeutic application of heat and massage to the eyelids.|Comprised of two components, a single-use disposable unit made of biocompatible polycarbonate and silicone that is inserted around the patient's eyelids, and a handheld control system, which connects to the single-use disposable unit|Battery-operated, handheld device that the physician uses in an in-office procedure to control the application of warmth and massage to the eyelids. The handheld device connects to a single-use disposable unit made of biocompatible polycarbonate and silicone that is inserted around the patient's eyelids. The device provides controlled warmth to the inner eyelid surface, close to the location of the meibomian glands, and intermittent massage to the outer eyelid surface to facilitate release of lipid from the cystic meibomian glands.|eyelids|N|N
OP|OP|OTZ|Graft Insertion Instrument For Endothelial Keratoplasty|1||N|N||886.4300|1|A graft insertion device for endothelial keratoplasty is a device intended to be inserted into the eye during surgery to direct the insertion of a corneal graft and be removed after insertion is completed.|Multiple different configurations may exist: similar to intraocular lens guide/injector, retractable spatula, multiple component systems, etc. Design is meant to specifically deliver corneal graft into eye.|A graft insertion device for endothelial keratoplasty functions as a protective guide for the insertion of a donor corneal graft through a corneal incision. Once the graft tissue has been loaded into the insertion device, the device is inserted through the corneal incision in the subject's eye. Once in the eye, the operator can then releases or dispenses the tissue graft from the device. Following graft release, the graft insertion device is removed.|Eye|N|N
OP|OP|OUM|Adaptometer (Biophotometer), Software-Based Data Acquistion And Stimulus Generation|1||N|N||886.1050|1|Measurement of retinal adaptation (regeneration of the visual purple) and absolute visible sensitivity to light.|The device is typically plastic or metal enclosed and desk top-based. In the enclosure are electronic components, including a light source, measurement components. and electronics containing software for data acquisition and stimulus generation.|A light source stimulates the retina and the the time required for retinal adaptation (regeneration of the visual purple) is measured. The minimum light threshold is also determined, in this same fashion.    Stimulus generation and data acquisition are the only features of the device which are software controlled.|Retina and ocular structures|N|N
OP|OP|PIC|Oral Electronic Vision Aid|2||N|N||886.5905|1|To use as an oral electronic vision aid in conjunction with other assistive devices (e.g., the white cane, guide dog, etc.)|headset (camera, glasses), intra-oral electrode array, battery, cable, software package|Translates images of objects captured by a digital camera into electro-tactile signals that are presented to the user's tongue.|tongue, eyes|N|N
OP|OP|PJZ|Camera, Ophthalmic, Ac-Powered, General-Use|2||N|N||886.1120|4|An ophthalmic camera intended to capture and store images of the eye and surrounding area.|The device is a self-contained unit consisting of hardware (lens, camera sensor), software (capable of storing and basic processing), and a light source.  The device is AC-powered.|The images may be captured by use with or without mydriatic agents. The device makes use of a series of lenses to capture a clear, high-resolution, non-distorted image of the eye (e.g., retina). Light may be provided by sources such as LED, halogen or incandescent bulb; however, the optical radiation assessment shall not exceed a group 1 determination per ISO 15004-2:2007. The device shall also not incorporate the use of a reference database.|The target area is the eye (lid, orbit) and ocular tissues (anterior and posterior segment).|N|N
OP|RA|NFF|Device, Storage, Images, Ophthalmic|1||N|N||892.2010|4|||||N|N
OP|RA|NFG|Device, Communications, Images, Ophthalmic|1||N|N||892.2020|4|||||N|N
OP|RA|NFH|Digitizer, Images, Ophthalmic|2||N|P||892.2030|7|||||N|N
OP|RA|NFI|Device, Hardcopy, Images, Ophthalmic|2||N|P||892.2040|7|||||N|N
OP|RA|NFJ|System, Image Management, Ophthalmic|2||N|P||892.2050|1|||||N|N
OP||HPX|Lens, Contact (Polymethylmethacrylate)|U|1|N|N|||1|||||N|N
OP||LOG|Catheter, Balloon For Retinal Reattachment|3||N|N|||2|||||N|N
OP||LOH|System, Identification, Contact Lens|3||N|N|||2|||||N|N
OP||LOI|Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary|3||N|N|||2|||||N|N
OP||LQB|Medical Computers And Software For Ophthalmic Use|3||N|N|||3|||||N|N
OP||LQE|Implant, Corneal, Refractive|f||N|N|||6|||||Y|N
OP||LXP|Plug, Scleral|U|1|N|N|||1|||||N|N
OP||LXQ|Cup, Eye|U|1|N|N|||1|||||N|N
OP||LYX|Media, Corneal Storage|U|1|N|N|||1|||||N|N
OP||LZQ|Tissue Adhesive For Ophthalmic Use|3||N|N|||2|||||N|N
OP||LZR|Ultrasound, Cyclodestructive|3||N|N|||2|||||N|N
OP||LZS|Excimer Laser System|3||N|N|||2|||||N|N
OP||LZU|Plug, Punctum|U|1|N|N|||1|||||N|N
OP||MML|Weights, Eyelid, External|U|1|N|N|||1|||||N|N
OP||MRJ|Ring, Endocapsular|3||N|N|||2|||||Y|N
OP||MSG|Ophthalmoscopes,Replacement Batteries,Hand-Held|U|1|N|N|||1|||||N|N
OP||MSI|Solution, Cleaning/Lubricating, Artifical Eye|3||N|N|||2|||||N|N
OP||MTA|Lens, Intraocular, Phakic|3||N|N|||2|||||Y|N
OP||MUR|Graft, Sclera, Reinforcement|3||N|N|||3|||||Y|N
OP||MWD|Electrosurgical,Radio Frequency,Refractive Correction|3||N|N|||2|||||N|N
OP||NBF|Prosthesis,Retinal|f||N|N|||6|||||Y|N
OP||NCJ|Telescope, Implantable, Miniature|3||N|N|||2|||||Y|N
OP||ODK|Refractive Corneal Implant|f||N|N|||6|Intended for the reduction or elimination of myopia and astigmatism in patients with keratoconus so that their functional vision may be restored and the need for a corneal transplant procedure may be potentially deferred.|Two clear polymethylmethacrylate segments, each having an arc length of 150 degree.|When placed in the corneal stroma outside of the patient's central optical zone, the product reduces the cone by flattening the cornea and for non-central keratoconus repositions the cone centrally.|Corneal stroma|Y|N
OP||OGO|Intraocular Pressure Lowering Implant|3||N|N|||2|An intraocular pressure lowering implant is a device intended to reduce intraocular pressure when implanted in eyes which have not failed conventional medical and surgical treatment.|This device category includes various materials, both biodegradable and non-biodegradable, and includes devices of various designs.|An intraocular pressure lowering implant uses various methods such as increasing aqueous outflow to reduce intraocular pressure|Eye|Y|N
OP||OKS|Lacrimal Stents And Intubation Sets|U|1|N|N|||1|Lacrimal stents and intubations sets are intended to repair the lacrimal drainage system.  Lacrimal stents and intubations sets are indicated for, but limited to, the treatment of epiphora in infants and adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in an infant.|A stent is a small tube generally made of silicone that is placed at the point of constriction to open it up. The intubation set is composed of a balloon and catheter composed of silicone.|The nasal punctum is probed with a fine stainless steel probe to determine the patency of the opening and adjoining lacrimal duct. This procedure is known as dilation and then maybe followed by sterile saline irrigation to test for lower patency of the lacrimal duct. In some cases, dilation and irrigation alone are not sufficient. In those cases, a balloon and cathether composed of silicone is inserted into the punctum and then into the lacrimal duct to keep the nasolacrimal duct open thereby facilitating the drainage of tear fluid from the eye.|These devices are restricted to the nasal punctum and lacrimal ducts of the eye.|Y|N
OP||OXW|Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy|N|3|N|N|||3|Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through the electrodes to the patient's eyelid to create a microcurrent loop that flows through the retina.|Electrical stimulation unit with leads and cutaneous electrodes|Applies an electrical current through electrodes on a patient's eyelid (skin)|Eyelid|N|N
OP||PFZ|Ophthalmic Sealant|3||N|N|||2|An ophthalmic sealant is intended to maintain an incision closure and aid in preventing fluid egress from incisions in the eye.|A topical liquid/hydrogel/material which creates a temporary adherent closure.|An ophthalmic sealant device is applied to an incision in the eye following an intraocular surgery. Once applied to the surface of the eye, the device adheres to the ocular tissue and aids in incision closure and prevention of fluid egress.|eye|N|N
OR|NE|OAN|Orthosis, Cranial, Laser Scan|2||N|N||882.5970|1|A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape.  A laser scanning accessory may be used to create a scan of the infant's head.  Indicated for infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.|Cranial orthotics are custom-made for each patient's head.  They are typically made from plastics, foam and velcro.|A mold is made of the baby's head to create the orthotic.  Plaster or laser scanning may be used to create the mold.|Infant craniums|N|N
OR|NE|OLO|Orthopedic Stereotaxic Instrument|2||N|N||882.4560|1|Stereotaxic guidance during orthopedic surgery procedures.  Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.|Device consists of Camera, computer, various shaped tracking arrays, computer interface for commmunication between user and device.|User loads Computer software pre-Op to plan surgery procedure, then registers the patient anatomy during surgery to allow software to track patient anatomy, implants, and surgical tools in real time/space.|Orthopedic joints and spinal procedures where tracking of instrumentation is desired.|N|N
OR|NE|OSE|Patient Specific Manual Navigation System|2||N|N||882.4560|1|Intended for defining implant alignment relative to a patient's anatomy.|Manual Instrument with auxiliary software.|Pre-operative imagery is used to establish a correlation between the patient's anatomy and the instrument.|Orthopedic Joints|N|N
OR|NE|OSF|Patient Specific Manual Orthopedic Stereotaxic System|2||N|N||882.4560|1|Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy.|Manual instrument and auxiliary software.|Pre-operative imagery, such as CT or radiographs, is used to establish a correlation between the patient's AP plane and the instrument¿s plane.|Acetabulum|N|N
OR|OR|HRR|Scissors, Orthopedic, Surgical|1||N|N||888.4540|4|||||N|N
OR|OR|HRS|Plate, Fixation, Bone|2||N|N||888.3030|1|||||Y|N
OR|OR|HRT|Stripper, Surgical|1||N|N||888.4540|4|||||N|N
OR|OR|HRW|Dynamometer, Nonpowered|1||N|N||888.1250|4|||||N|N
OR|OR|HRX|Arthroscope|2||N|Y|M|888.1100|1|||||N|N
OR|OR|HRY|Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer|2||N|N||888.3530|1|||||Y|N
OR|OR|HRZ|Prosthesis, Knee, Hinged (Metal-Metal)|3||N|N||888.3480|2|PMAs to be filed by 12/26/96 (61 FR 50710 (9/27/96))||||Y|N
OR|OR|HSA|Prosthesis, Knee, Hemi-, Femoral|3||N|N||888.3570|2|||||Y|N
OR|OR|HSB|Rod, Fixation, Intramedullary And Accessories|2||N|N||888.3020|1|||||Y|N
OR|OR|HSD|Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented|2||N|N||888.3690|1|||||Y|N
OR|OR|HSH|Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)|2||N|N||888.3590|1|||||Y|N
OR|OR|HSN|Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer|2||N|N||888.3110|1|||||Y|N
OR|OR|HSP|Splint, Traction|1||Y|N||888.5890|4|||||N|N
OR|OR|HSQ|Belt, Pelvic, Traction|1||Y|N||888.5890|4|||||N|N
OR|OR|HSR|Unit, Traction, Hip, Non-Powered, Non-Penetrating|1||Y|N||888.5890|4|||||N|N
OR|OR|HSS|Halter, Head, Traction|1||Y|N||888.5890|4|||||N|N
OR|OR|HST|Apparatus, Traction, Non-Powered|1||Y|N||888.5850|4|||||N|N
OR|OR|HSX|Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer|2||N|N||888.3520|1|||||Y|N
OR|OR|HTG|Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented|2||N|N||888.3580|1|||||Y|N
OR|OR|HTH|Protractor|1||N|N||888.4600|4|||||N|N
OR|OR|HTJ|Gauge, Depth|1||N|N||888.4300|4|||||N|N
OR|OR|HTN|Washer, Bolt Nut|2||N|N||888.3030|1|||||Y|N
OR|OR|HTO|Reamer|1||N|N||888.4540|4|||||N|N
OR|OR|HTP|File|1||N|N||888.4540|4|||||N|N
OR|OR|HTQ|Broach|1||N|N||888.4540|4|||||N|N
OR|OR|HTS|Knife, Orthopedic|1||N|N||888.4540|4|||||N|N
OR|OR|HTT|Burr, Orthopedic|1||N|N||888.4540|4|||||N|N
OR|OR|HTW|Bit, Drill|1||N|N||888.4540|4|||||N|N
OR|OR|HTX|Rongeur|1||N|N||888.4540|4|||||N|N
OR|OR|HTY|Pin, Fixation, Smooth|2||N|N||888.3040|1|||||Y|N
OR|OR|HWA|Impactor|1||N|N||888.4540|4|||||N|N
OR|OR|HWB|Extractor|1||N|N||888.4540|4|||||N|N
OR|OR|HWC|Screw, Fixation, Bone|2||N|N||888.3040|1|||||Y|N
OR|OR|HWD|Starter, Bone Screw|1||N|N||888.4540|4|||||N|N
OR|OR|HWI|Corkscrew|1||N|N||888.4540|4|||||N|N
OR|OR|HWJ|Awl|1||N|N||888.4540|4|||||N|N
OR|OR|HWK|Trephine|1||N|N||888.4540|4|||||N|N
OR|OR|HWL|Set, Hollow Mill|1||N|N||888.4540|4|||||N|N
OR|OR|HWN|Instrument, Compression|1||N|N||888.4540|4|||||N|N
OR|OR|HWO|Skid, Bone|1||N|N||888.4540|4|||||N|N
OR|OR|HWP|Punch, Femoral Neck|1||N|N||888.4540|4|||||N|N
OR|OR|HWQ|Passer|1||N|N||888.4540|4|||||N|N
OR|OR|HWR|Driver, Prosthesis|1||N|N||888.4540|4|||||N|N
OR|OR|HWT|Template|1||N|N||888.4800|4|||||N|N
OR|OR|HWW|Countersink|1||N|N||888.4540|4|||||N|N
OR|OR|HWX|Tap, Bone|1||N|N||888.4540|4|||||N|N
OR|OR|HXA|Prosthesis, Tendon, Passive|2||N|N||888.3025|1|||||Y|N
OR|OR|HXB|Probe|1||N|N||888.4540|4|||||N|N
OR|OR|HXC|Wrench|1||N|N||888.4540|4|||||N|N
OR|OR|HXE|Fork|1||N|N||888.4540|4|||||N|N
OR|OR|HXG|Tamp|1||N|N||888.4540|4|||||N|N
OR|OR|HXI|Passer, Wire, Orthopedic|1||N|N||888.4540|4|||||N|N
OR|OR|HXJ|Staple Driver|1||N|N||888.4540|4|||||N|N
OR|OR|HXK|Holder, Needle; Orthopedic|1||N|N||888.4540|4|||||N|N
OR|OR|HXN|Applier, Cerclage|1||N|N||888.4540|4|||||N|N
OR|OR|HXO|Pusher, Socket|1||N|N||888.4540|4|||||N|N
OR|OR|HXP|Instrument, Bending Or Contouring|1||N|N||888.4540|4|||||N|N
OR|OR|HXQ|Crimper, Pin|1||N|N||888.4540|4|||||N|N
OR|OR|HXS|Twister, Wire|1||N|N||888.4540|4|||||N|N
OR|OR|HXW|Bender|1||N|N||888.4540|4|||||N|N
OR|OR|HXX|Screwdriver|1||N|N||888.4540|4|||||N|N
OR|OR|HXY|Brace, Drill|1||N|N||888.4540|4|||||N|N
OR|OR|HXZ|Cutter, Wire|1||N|N||888.4540|4|||||N|N
OR|OR|JDB|Prosthesis, Elbow, Semi-Constrained, Cemented|2||N|N||888.3160|1|||||Y|N
OR|OR|JDC|Prosthesis, Elbow, Constrained, Cemented|2||N|N||888.3150|1|||||Y|N
OR|OR|JDD|Prosthesis, Upper Femoral|2||N|N||888.3360|1|||||Y|N
OR|OR|JDG|Prosthesis, Hip, Femoral Component, Cemented, Metal|2||N|N||888.3360|1|||||Y|N
OR|OR|JDI|Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented|2||N|N||888.3350|1|||||Y|N
OR|OR|JDL|Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)|3||N|N||888.3320|1|||||Y|N
OR|OR|JDN|Implant, Fixation Device, Spinal|2||N|N||888.3060|1|||||Y|N
OR|OR|JDO|Device, Fixation, Proximal Femoral, Implant|2||N|N||888.3030|1|||||Y|N
OR|OR|JDP|Condylar Plate Fixation Implant|2||N|N||888.3030|1|||||Y|N
OR|OR|JDQ|Cerclage, Fixation|2||N|N||888.3010|1|||||Y|N
OR|OR|JDR|Staple, Fixation, Bone|2||N|N||888.3030|1|||||Y|N
OR|OR|JDS|Nail, Fixation, Bone|2||N|N||888.3030|1|||||Y|N
OR|OR|JDT|Cap, Bone|1||N|N||888.3000|4|||||Y|N
OR|OR|JDW|Pin, Fixation, Threaded|2||N|N||888.3040|1|||||Y|N
OR|OR|JDX|Instrument, Surgical, Sonic And Accessory/Attachment|2||N|P||888.4580|1|||||N|N
OR|OR|JDY|Evacuator, Vapor, Cement Monomer|1||N|N||888.4220|4|||||N|N
OR|OR|JDZ|Mixer, Cement, For Clinical Use|1||N|N||888.4210|4|||||N|N
OR|OR|JEC|Component, Traction, Invasive|2||N|N||888.3040|1|||||Y|N
OR|OR|JWH|Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer|2||N|N||888.3560|1|||||Y|N
OR|OR|JWI|Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained|2||N|N||888.3800|1|||||Y|N
OR|OR|JWJ|Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained|2||N|N||888.3800|1|||||Y|N
OR|OR|KIG|Prosthesis, Wrist, Constrained, Polymer|2||N|N||888.3780|1|||||Y|N
OR|OR|KIH|Dispenser, Cement|1||N|N||888.4200|4|||||N|N
OR|OR|KII|Tube, Cement Ventilation|1||N|N||888.4230|4|||||N|N
OR|OR|KIL|Positioner, Socket|1||N|N||888.4540|4|||||N|N
OR|OR|KMB|Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented|2||N|N||888.3490|1|||||Y|N
OR|OR|KMC|Prosthesis, Hip, Semi-Constrained,  Composite/Metal|2||N|N||888.3340|1|||||Y|N
OR|OR|KMD|Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite|2||N|N||888.3100|1|||||Y|N
OR|OR|KQW|Goniometer, Nonpowered|1||N|N||888.1520|4|||||N|N
OR|OR|KQX|Goniometer, Ac-Powered|1||N|Y|M|888.1500|4|||||N|N
OR|OR|KQZ|Component, Traction, Non-Invasive|1||Y|N||888.5890|4|||||N|N
OR|OR|KRN|Metal Cemented Constrained Femorotibial Knee Prosthesis|3||N|N||888.3480|2|Call for pmas 12/26/96 ( 61 fr 50710 9/27/96)||||Y|N
OR|OR|KRO|Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer|2||N|N||888.3510|1|||||Y|N
OR|OR|KRP|Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal|3||N|N||888.3550|2|Call for PMAs to be filed by 12/26/96 per 61 FR 50710 on 9/27/96||||Y|N
OR|OR|KRQ|Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer|2||N|N||888.3550|1|||||Y|N
OR|OR|KRR|Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer|2||N|N||888.3540|1|||||Y|N
OR|OR|KRS|Prosthesis, Knee, Hemi-, Femoral (Uncemented)|3||N|N||888.3570|2|||||N|N
OR|OR|KTT|Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component|2||N|N||888.3030|1|||||Y|N
OR|OR|KTW|Appliance, Fixation, Nail/Blade/Plate Combination, Single Component|2||N|N||888.3030|1|||||Y|N
OR|OR|KTX|Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented|2||N|N||888.3490|1|||||Y|N
OR|OR|KTZ|Caliper|1||N|N||888.4150|4|||||N|N
OR|OR|KWA|Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)|3||N|N||888.3330|1|||||Y|N
OR|OR|KWB|Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal|3||N|N||888.3370|2|Call for PMAs 12/26/96 (61 FR 50710 (9/27/96))||||Y|N
OR|OR|KWD|Prosthesis, Toe, Hemi-, Phalangeal|2||N|N||888.3730|1|||||Y|N
OR|OR|KWE|Prosthesis, Finger, Constrained, Metal, Uncemented|3||N|N||888.3200|2|call for pmas to be filed by 12/26/96 per 61 FR 50709 on 9/27/96||||Y|N
OR|OR|KWF|Prosthesis, Finger, Polymer|2||N|N||888.3230|1|||||Y|N
OR|OR|KWG|Prosthesis, Finger, Constrained, Metal/Polymer|3||N|N||888.3220|2|Call for PMAs to be filed by 12/26/96 per 61 FR 50709 on 9/27/96||||Y|N
OR|OR|KWH|Prosthesis, Toe, Constrained, Polymer|2||N|N||888.3720|1|||||Y|N
OR|OR|KWI|Prosthesis, Elbow, Hemi-, Radial, Polymer|2||N|N||888.3170|1|||||Y|N
OR|OR|KWJ|Prosthesis, Elbow, Hemi-, Humeral, Metal|3||N|N||888.3180|2|call for pmas to be filed by 12/26/96 per 61 FR 50709 on 9/27/96||||Y|N
OR|OR|KWK|Appliance, Nail/Blade/Plate Combination, Single Component|2||N|N||888.3030|1|||||Y|N
OR|OR|KWL|Prosthesis, Hip, Hemi-, Femoral, Metal|2||N|N||888.3360|1|||||Y|N
OR|OR|KWM|Prosthesis, Wrist, Semi-Constrained|2||N|N||888.3800|1|||||Y|N
OR|OR|KWN|Prosthesis, Wrist, Carpal Lunate|2||N|N||888.3750|1|||||Y|N
OR|OR|KWO|Prosthesis, Wrist, Carpal Scaphoid|2||N|N||888.3760|1|||||Y|N
OR|OR|KWP|Appliance, Fixation, Spinal Interlaminal|2||N|N||888.3050|1|||||Y|N
OR|OR|KWQ|Appliance, Fixation, Spinal Intervertebral Body|2||N|N||888.3060|1|||||Y|N
OR|OR|KWR|Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented|3||N|N||888.3640|2|Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96||||Y|N
OR|OR|KWS|Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented|2||N|N||888.3660|1|||||Y|N
OR|OR|KWT|Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented|2||N|N||888.3650|1|||||Y|N
OR|OR|KWY|Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented|2||N|N||888.3390|1|||||Y|N
OR|OR|KWZ|Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer|2||N|N||888.3310|1|||||Y|N
OR|OR|KXA|Prosthesis, Hip, Femoral, Resurfacing|2||N|N||888.3400|1|||||Y|N
OR|OR|KXB|Prosthesis, Hip, Pelvifemoral Resurfacing,  Metal/Polymer|3||N|N||888.3410|2|Pma to be filed by 1/3/05 (69 fr 59134 (10/4/04)) for any hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976, or that has, on or before january 3, 2005, been found to be substantially equivalent to a hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976. Any other hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis must have an approved pma or a declared completed pdp in effect before being placed in commercial distribution.||||Y|N
OR|OR|KXC|Prosthesis, Ankle, Cemented, Non-Constrained|3||N|N||888.3120|2|||||Y|N
OR|OR|KXD|Prosthesis, Hip, Constrained, Metal|3||N|N||888.3300|2|Call for PMAs 12/26/96 (61 FR 50709 (9/27/96))||||Y|N
OR|OR|KXE|Prosthesis, Wrist, Hemi-, Ulnar|2||N|N||888.3810|1|||||Y|N
OR|OR|KYI|Prosthesis, Wrist, Carpal Trapezium|2||N|N||888.3770|1|||||Y|N
OR|OR|KYJ|Prosthesis, Finger, Constrained, Polymer|2||N|N||888.3230|1|||||Y|N
OR|OR|KYK|Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite|2||N|N||888.3500|1|||||Y|N
OR|OR|KYM|Metallic Cemented Glenoid Hemi-Shoulder Prosthesis|3||N|N||888.3680|2|Call for pmas to be filed by 12/26/96 per 61 fr 50711 on 9/27/96||||Y|N
OR|OR|KYN|Prosthesis, Wrist, Constrained, Metal|3||N|N||888.3790|2|Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96||||Y|N
OR|OR|LBB|Dynamometer, Ac-Powered|2||N|P||888.1240|1|||||N|N
OR|OR|LBC|Prosthesis, Finger, Constrained, Metal, Cemented|3||N|N||888.3210|2|Call for PMAs to be filed by 12/26/96 per 61 FR 50709 on 9/27/96||||Y|N
OR|OR|LGE|Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing|2||N|N||888.3530|1|||||Y|N
OR|OR|LGF|Component, Cast|1||Y|N||888.5940|4|||||N|N
OR|OR|LGG|Instrument, Cast Application/Removal, Manual|1||Y|N||888.5980|4|||||N|N
OR|OR|LGH|Instrument, Cast Removal, Ac-Powered|1||N|N||888.5960|4|||||N|N
OR|OR|LOD|Bone Cement|2||N|N||888.3027|1|||||Y|N
OR|OR|LPH|Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented|2||N|N||888.3358|1|||||Y|N
OR|OR|LTO|Spacer, Cement|3||N|N||888.3320|1|||||Y|N
OR|OR|LWJ|Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented|2||N|N||888.3360|1|||||Y|N
OR|OR|LXH|Orthopedic Manual Surgical Instrument|1||N|N||888.4540|4|||||N|N
OR|OR|LXT|Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite|2||N|N||888.3030|1|||||Y|N
OR|OR|LYP|Accessories, Fixation, Spinal Interlaminal|2||N|N||888.3050|1|||||Y|N
OR|OR|LYS|Bone Mill|1||N|N||888.4540|4|||||N|N
OR|OR|LYT|Fixation Accessory|2||N|N||888.3030|1|||||Y|N
OR|OR|LZO|Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented|2||N|N||888.3353|1|||||Y|N
OR|OR|LZV|System, Cement Removal Extraction|2||N|P||888.4580|1|||||N|N
OR|OR|LZY|Prosthesis, Hip, Hemi-, Femoral, Metal Ball|2||N|N||888.3360|1|||||Y|N
OR|OR|MAI|Fastener, Fixation, Biodegradable, Soft Tissue|2||N|N||888.3030|1|||||N|N
OR|OR|MAX|Intervertebral Fusion Device With Bone Graft, Lumbar|2||N|N||888.3080|1|Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.|hollow cylinder or rectangular box made of metal or polymer|Acts as a disc spacer and holds bone graft.|intervertebral disc space|Y|N
OR|OR|MAY|Prosthesis,  Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish|2||N|N||888.3353|1|||||Y|N
OR|OR|MBB|Bone Cement, Antibiotic|2||N|N||888.3027|1|||||Y|N
OR|OR|MBF|Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented|2||N|N||888.3670|1|||||Y|N
OR|OR|MBH|Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer|2||N|N||888.3565|1|||||Y|N
OR|OR|MBI|Fastener, Fixation, Nondegradable, Soft Tissue|2||N|N||888.3040|1|||||Y|N
OR|OR|MBL|Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous|2||N|N||888.3358|1|||||Y|N
OR|OR|MBV|Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer|2||N|N||888.3560|1|||||Y|N
OR|OR|MEH|Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate|2||N|N||888.3353|1|||||Y|N
OR|OR|MNH|Orthosis, Spondylolisthesis Spinal Fixation|2||N|N||888.3070|1|||||Y|N
OR|OR|MNI|Orthosis, Spinal Pedicle Fixation|2||N|N||888.3070|1|||||Y|N
OR|OR|MNU|Staple, Absorbable|2||N|N||888.3030|1|||||Y|N
OR|OR|MQP|Spinal Vertebral Body Replacement Device|2||N|N||888.3060|1|||||Y|N
OR|OR|MQV|Filler, Bone Void, Calcium Compound|2||N|N||888.3045|1|||||Y|N
OR|OR|NBH|Accessories,Arthroscopic|1||N|N||888.1100|4|||||N|N
OR|OR|NDD|Cerclage, Fixation, Metallic|2||N|N||888.3010|1|||||Y|N
OR|OR|NDE|Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible|2||N|N||888.3020|1|||||Y|N
OR|OR|NDF|Plate, Fixation, Bone, Non-Spinal, Metallic|2||N|N||888.3030|1|||||Y|N
OR|OR|NDG|Washer, Bolt, Nut, Non-Spinal, Metallic|2||N|N||888.3030|1|||||Y|N
OR|OR|NDH|Nail, Fixation, Bone, Metallic|2||N|N||888.3030|1|||||Y|N
OR|OR|NDI|Staple, Fixation, Bone, Metallic|2||N|N||888.3030|1|||||Y|N
OR|OR|NDJ|Screw, Fixation, Bone, Non-Spinal, Metallic|2||N|N||888.3040|1|||||Y|N
OR|OR|NDK|System, External Fixator (With Metallic Invasive Components)|2||N|N||888.3040|1|||||Y|N
OR|OR|NDL|Pin, Fixation, Smooth, Metallic|2||N|N||888.3040|1|||||Y|N
OR|OR|NDM|Pin, Fixation, Threaded, Metallic|2||N|N||888.3040|1|||||Y|N
OR|OR|NDN|Cement, Bone, Vertebroplasty|2||N|N||888.3027|1|||||Y|N
OR|OR|NGR|Tester, Stiffness, Cartilage, Arthroscopic|2||N|P||888.1100|1|||||N|N
OR|OR|NJA|Accessory, System, External Fixator, Containing Antimicrobial Agent|2||N|N||888.3040|1|The device is intended to be used as an accessory surrounding orthopedic pins and wires during external fixation of bones.  The sleeve is impregnated with antibiotic (gentamicin) which is released over time in order to inhibit bacterial colonization on the pin/wire.||||Y|N
OR|OR|NJD|Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer|2||N|N||888.3535|1|Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revision surgery.||||Y|N
OR|OR|NKB|Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease|3||N|N||888.3070|1|Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at l5-s1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.||||Y|N
OR|OR|NKI|Goniometer With Electrodes|2||N|N||888.1500|4|A goniometer is an AC-powered or battery powered  device intended to evaluate joint function by measuring and recording range of motion, acceleration, or forces exerted by a joint. The class II (special controls) goniometer uses transcutaneous adhesive electrode lead wires and patient cables to transmit and record patient data.||||N|N
OR|OR|NOV|Anchor, Suture, Bone Fixation, Metallic|2||N|N||888.3030|1|This device is indicated for attaching suture into bone for suspension of the nasal valve and for attaching suture into bone at the lower orbital rim.||||Y|N
OR|OR|NPJ|Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer|2||N|N||888.3560|1|The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device.  The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella.  The device is intended to be used with bone cement.||||Y|N
OR|OR|NQP|Posterior Metal/Polymer Spinal System, Fusion|2||N|N||888.3070|1|This device is a posterior spinal system that contains polymer and metal components.  This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.||||Y|N
OR|OR|NQW|Orthosis, Spine, Plate, Laminoplasty, Metal|2||N|N||888.3050|1|This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.||||Y|N
OR|OR|NUD|Vertebroplasty Compound, Calcium Based|2||N|N||888.3027|1|THIS DEVICE IS INDICATED FOR THE FIXATION OF PATHOLOGICAL FRACTURES OF THE VERTEBRAL BODY USING VERTEBROPLASTY OR KYPHOPLASTY PROCEDURES.   THE DEVICE RESORBS (TIME FRAME MAY BE INDICATED) AND IS REPLACED WITH BONE DURING THE HEALING PROCESS.||||Y|N
OR|OR|NVC|Bone, Heterograft|3||N|N||888.3015|2|BONE HETEROGRAFT IS A DEVICE INTENDED TO BE IMPLANTED THAT IS MADE FROM MATURE (ADULT) BOVINE BONES AND USED TO REPLACE HUMAN BONE FOLLOWING SURGERY IN THE CERVICAL REGION OF THE SPINAL COLUMN.||||Y|N
OR|OR|NWN|Kit, Laparoscopic, Bone Anchor, Urethropexy|2||N|P||888.3040|1|Laparoscopic bone anchor urethropexy instrument kit|Laparoscopic Bone Anchor Urethropexy Instrument Kit|Laparoscopic Bone Anchor Urethropexy Instrument Kit|Laparoscopic Bone Anchor Urethropexy Instrument Kit|N|N
OR|OR|OAR|Injector, Vertebroplasty (Does Not Contain Cement)|1||N|N||888.4200|4|Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).|plastic syringe type device -- some embodiments may include levers or screws to increase injection force or control|Uses mechanical force to inject  bone cement into vertebra|vertebra|N|N
OR|OR|OBL|Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty|2||N|N||888.3027|1|Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.|Interlocking pre-formed polymeric (e.g., PEEK) components sized to the desired vertebral body dimensions|Implanted modularly within the vertebral body until desired height is achieved, then encapsulated in PMMA.|Thoracic or lumbar vertebral bodies|Y|N
OR|OR|OBM|Cement, Bone, Vertebroplasty, Pre-Formed, Modular|2||N|N||888.3027|1|Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.|Interlocking pre-formed PMMA components sized to the desired vertebral body dimensions|Implanted modularly within the vertebral body until desired dimensions are achieved, then encapsulated in PMMA|Thoracic or lumbar vertebral bodies|Y|N
OR|OR|OBT|Plate, Bone, Growth Control, Pediatric, Epiphysiodesis|2||N|N||888.3030|1|Intended to redirect the angle of growth of long bone(s) only in pediatric patients. Indicated for temporary or permanent epiphysiodesis.  For gradually correcting angular deformities of long bones in pediatric patients with an open physis.  Specific conditions/diseases for which the device will be indicated include valgus, varus, or flexion extension deformities of the knee (femur and/or tibia); valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow, as well as radial or ulnar deviation, flexion or extension deformities of the wrist (radius).  The device may be removed when growth has equalized or the growth plate has fused.|Metallic bone fixation appliances and accessories|Mechanical bone fixation|Long bone growth plates only.  Spinal indications require additional testing, labeling and an different product code.|Y|Y
OR|OR|OCG|Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented|3||N|N||888.3410|2|Call for PMAs to be filed by 1/3/05 per 69 FR 59134 on 10/4/04 - Intended to replace the articulating surfaces of the hip while preserving the femoral head and neck and indicated for osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis of the femoral head.|This generic type of device includes prostheses that consist of a femoral cap component made of a metal alloy, such as cobalt-chromium-molybdenum, or a ceramic material, that is placed over a surgically prepared femoral head, and an acetabular resurfacing polymer component.|The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint.|hip joint|Y|N
OR|OR|OCJ|Spinal Channeling Instrument, Vertebroplasty|1||N|N||888.4540|4|Create channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA) prior to a vertebroplasty procedure.  Treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions.|Composed of cannula for placement within the vertebral body and cutting element that is deployed by the surgeon once the cannula is placed.|Device placed within cancellous bone of vertebral body and then cutting element advanced forward out of device by surgeon to create channel for cement flow.|Vertebral body.|N|N
OR|OR|ODP|Intervertebral Fusion Device With Bone Graft, Cervical|2||N|N||888.3080|1|Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.|Hollow cylinder or rectangular box made of metal or polymer.|Acts as a disc spacer and holds bone graft.|Intervertebral disc space.|Y|N
OR|OR|OIS|Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation|2||N|N||888.3045|1|To fill traumatic or surgically-created defects not intrinsic to the stability of the bony structure.  It is delivered to the defect and resorbs over time to be replaced by bone.  Not for screw augmentation.|bone void filler and mixing and delivery system|placed or injected in bony defects|various, specified bone voids (e.g., extremeties, pelvis)|Y|N
OR|OR|OIY|Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive|2||N|N||888.3560|1|Indicated for:  1.	Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.  2.	Correction of varus, valgus, or posttraumatic deformity.  3.	Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.    For cemented use.|May include:    Femoral Component  Tibial Component  Metal Backed Patellar Component  Tibial Insert  Patella Insert  All Poly Patellar Component  Instrumentation|This device is intended to be implanted to replace a knee joint.  The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces.  It has no linkage across the joint.  This generic type of device includes prosthesis that have a femoral component mode of alloys, such as cobalt-chromium-molybdenum, and a tibial component(s) and/or a retropatellar resurfacing component made of ultra-high molecular weight polyethylene plus an additive, such as a-tocopherol.|Knee|Y|N
OR|OR|OJB|Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate|2||N|N||888.3060|1|Maintain position of bone graft in spinal fusion procedures. Intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, in conjunction with traditional rigid fixation.|Plates and screws made from resorbable materials such polylactic acid|Attaches to anterior column of spine using screws|anterior column of lumbar or cervical spine|Y|N
OR|OR|OJM|Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh|2||N|N||888.3060|1|Maintain position of bone graft in spinal fusion procedures. Intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, in conjunction with traditional rigid fixation.|Meshes and screws made from resorbable materials such polylactic acid|Attaches to anterior column of spine using screws|Anterior column of lumbar or cervical spine|Y|N
OR|OR|OOG|Knee Arthroplasty Implantation System|2||N|N||888.3560|1|Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices.  Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.|A device accessory or set of device accessories;|Aids the surgeon in performing the implantation of the knee implant|Knee|N|N
OR|OR|OOL|Electronic Depth Gauge|2||N|N||888.3030|1|For measuring the depth of a passageway in bone or tissue, prior to insertion of screws or other hardware.  The device is an electronic depth gauge for various medical purposes including, measuring the depth of a passageway in a bone or other tissue.  It may enable the proper sizing of screws and implants in medical procedures.|May have components of metal and plastic, and includes a battery or power source, an LCD or other display, and software and/or firmware|Uses a mechanical sliding probe, in conjunction with hardware that creates a variable voltage input based on probe position and software, to display digitally a measured depth|Bone or tissue sites where tunnels or steps exist, or drilling or cutting has occurred|N|N
OR|OR|OQG|Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented|2||N|N||888.3358|1|1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.  2. Rheumatoid arthritis.  3. Correction of functional deformity.  4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.  5. Revision procedures where other treatment or devices have failed.  Cemented and uncemented use.|May include:    Acetabular Shell  Acetabular Liner  Femoral Head  Femoral Stem  Femoral Neck  Instrumentation|This device is intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene containing an additive such as a-tocopherol articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The stem/shell are coated with a porous coating to achieve cementless biological fixation.|Hip|Y|N
OR|OR|OQH|Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented|2||N|N||888.3350|1|1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.  2. Rheumatoid arthritis.  3. Correction of functional deformity.  4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.  5. Revision procedures where other treatment or devices have failed.  Cemented and uncemented use.|May include:    Acetabular Shell  Acetabular Liner  Femoral Head  Femoral Stem  Femoral Neck  Instrumentation|This device is intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene containing an additive such as a-tocopherol and is limited to those prostheses intended for use with bone cement.|hip|Y|N
OR|OR|OQI|Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented|2||N|N||888.3353|1|1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.  2. Rheumatoid arthritis.  3. Correction of functional deformity.  4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.  5. Revision procedures where other treatment or devices have failed.  Cemented and uncemented use.|May include:    Acetabular Shell  Acetabular Liner  Femoral Head  Femoral Stem  Femoral Neck  Instrumentation|A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A1203) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene containing an additive such as a-tocopherol, and used with or without bone cement.|hip|Y|N
OR|OR|OSH|Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis|2||N|N||888.3070|1|Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.|Bone screws, rods, and hooks intended to stabilize the spine as an adjunct to fusion|Acts as a spinal fusion system with autograft and/or allograft to stabilize the spine as an adjunct to fusion to treat adolescent idiopathic scoliosis|Posterior, non-cervical spinal column in adolescent patients|Y|N
OR|OR|OSN|Software For Diagnosis/Treatment|2||N|N||888.3030|1|Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions|Custom written or off the shelf software intended to be used with an orthopedic trauma device|Software operated by the manufacturer or end user intended to diagnose or treat an orthopedic condition|Musculoskeletal system|Y|N
OR|OR|OUR|Sacroiliac Joint Fixation|2||N|N||888.3040|1|sacroiliac joint fusion|may be used with bone graft, should not be used with bone cement|bridges both sides of the joint, preventing motion|sacroiliac joint|Y|N
OR|OR|OVD|Intervertebral Fusion Device With Integrated Fixation, Lumbar|2||N|N||888.3080|1|Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.|Hollow cylinder or rectangular box made of metal or polymer with integrated fixation.|Acts as a disc spacer and holds bone graft; also includes some form of integrated fixation to maintain stability by direct purchase into the bony vertebral endplates.|Intervertebral disc space|Y|N
OR|OR|OVE|Intervertebral Fusion Device With Integrated Fixation, Cervical|2||N|N||888.3080|1|Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.|Hollow cylinder or rectangular box made of metal or polymer with integrated fixation.|Acts as a disc spacer and holds bone graft; also includes some form of integrated fixation to maintain stability by direct purchase into the bony vertebral endplates.|Intervertebral disc space|Y|N
OR|OR|OVZ|Pin, Fixation, Resorbable, Hard Tissue|2||N|N||888.3040|1|Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications.|Supplied with various surgical instruments, may include stainless steel applicator tube, wire, gauge, pin plunger, arthroscopic kit.|This is a device that consists of a stiff wire segment or rod made of resorbable polymer and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. The device is intended to be implanted either through fracture fragments, intramedullary canal, or across a joint, and temporarily provide stabilization while healing or fusion occurs.|For various anatomic locations including knee, hand, finger and toe.|Y|N
OR|OR|OWI|Bone Fixation Cerclage, Sublaminar|2||N|N||888.3010|1|Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.|metallic wire, polyester bands|Wrapped around a portion of the sublaminar, posterior spine for temporary stabilization during spinal fusion procedures. May be used in conjunction with other medical implants made of similar metals whenever wiring" may help secure the attachment of other implants.|sublaminar, posterior spine|Y|N
OR|OR|OYK|Ankle Arthroplasty Implantation System|2||N|N||888.3110|1|Intended to be used to assist in the implantation of a specific ankle arthroplasty device.  Indicated to include guiding alignment, making or establishing cuts, and sizing.|A device accessory or a set of device accessories.|Aids the surgeon in performing the implantation of an ankle arthroplasty device.|Ankle|N|N
OR|OR|PAO|Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented|2||N|N||888.3660|1|Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.|May include:    Humeral stem  Humeral neck  Humeral tray  Glenoid component  Glenoid tray  Glenosphere  Fixation screws  Instrumentation|To be implanted to replace a shoulder joint.  It limits translation and rotation in one or more planes via the geometry of its articulating surfaces.  It has no linkage across the joint.  This generic type of device includes prosthesis that have a muheral component mode of alloys, such as CoCr or Ti alloys, and and a glenoid components made of ultra-high molecular weight polyethylene plus an additive, such as á-tocopherol. Reverse shoulder have a glenosphere made from CoCr and a humeral tray made from ultra-high molecular weight polyethylene plus an additive. The tray attaches to a metallic humeral stem.|Shoulder|Y|N
OR|OR|PBF|Orthopaedic Surgical Planning And Instrument Guides|2||N|N||888.3030|1|As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.|Software and hardware|for pre-surgical planning including transfering, visualizing, measuring, annotating and editing medical data.  Patient specific templates that are based on pre-operative plan and are designed to fit a specific patient.  These guides are used to assist a surgeon in guiding the marking of bone and/or guiding surgical instruments.|long bones|N|N
OR|OR|PBI|Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive|2||N|N||888.3310|1|For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.|System contains acvetabular screws, acetabular shell, constrained UHMWPE acetabular liner doped with an additive, a femoral ball, and a metallic femoral stem.|This device is intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. The liner constrains the head such that it prevent axial dislocation. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene containing an additive such as a-tocopherol articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The shell and stem can be attached to the bone by either cemented, pressfit, or biological fixation.|Hip|Y|N
OR|OR|PEK|Spinous Process Plate|2||N|N||888.3050|1|A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1).  It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Trauma (i.e., fracture or dislocation), Spondylolisthesis, and/or Tumor.  It is not intended for stand-alone use.|Plates with teeth/spikes and crossbar/tray/bumper that connects and locks plates together, metallic, metallic and polymer combination|Placed between two spinous processes to immobilize the segment, provide supplemental stabilization, and to facilitate fusion at the treated level|Non-cervical spine (T1-S1)|Y|N
OR|OR|PHM|Intervertebral Fusion Device With Bone Graft, Thoracic|2||N|N||888.3080|1|Intended to stabilize thoracic spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.|hollow cylinder or rectangular box made of metal or polymer|Acts as a disc spacer and holds bone graft.|intervertebral disc space|Y|N
OR|OR|PHQ|Anterior Staple As Supplemental Fixation For Fusion|2||N|N||888.3060|1|Anterior cervical device for supplemental fixation to support a fusion.|This is a metalic staple that is implanted into two adjacent vertebral bodies.|The staple provides physical support while a fusion develops between vertebral bodies.|This is intended for the anterior, cervical spinal column in skeletally mature patients.|Y|N
OR|OR|PHX|Shoulder Prosthesis, Reverse Configuration|2||N|N||888.3660|1|Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.|Typically includes humeral stem, humeral socket, humeral cup, glenosphere, and glenoid baseplate with fixation screws.  The humeral stem and humeral socket may be one single piece or two separate pieces locked together.  The humeral cup is snap fit into the humeral socket.  The humeral cup is made from UHMWPE and articulates with the glenosphere made of CoCrMo alloy, Titanium alloy, or stainless steel.  The glenosphere locks to glenoid baseplate which is fixed to the glenoid bone by 2-6 screws.  The glenoid baseplate has HA coating, metallic coating or no coating and may feature a central peg, central screw, central cage, or keel.|Relative to the native shoulder joint, the device moves the center of rotation medially and distally to the anatomic position which increases the length of the deltoid muscle's lever arm, allowing the same rotational moment with less applied force.|Shoulder joint|Y|N
OR|OR|PKC|Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained|2||N|N||888.3660|1|Replacement of the humeral head for total anatomic shoulder arthroplasty|Short metallic humeral stem contained entirely within the metaphysis.|Humeral head is resected and canal is created to accept humeral stem component|Shoulder. Proximal humerus.|Y|N
OR|OR|PLF|Bone Wedge|2||N|N||888.3030|1|Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.|Wedge  with or without graft window made of metal or polymer|A wedge that may act as a spacer and/or hold bone graft in opening wedge osteotomy procedures, column lengthening, or fusion|foot, ankle, proximal tibia|Y|N
OR|OR|PLR|Spinal Vertebral Body Replacement Device - Cervical|2||N|N||888.3060|1|Vertebral body replacement in the cervical spine.|Metallic or polymeric device (usually rectangular or cylindrical), with open central and lateral canals for bone graft containment, providing rigidity and structural support.|Provides structural support for the indicated population.|Cervical spine|Y|N
OR|OR|PLW|Acetabular Cup Orientation System|2||N|N||888.3350|1|The acetabular cup orientation system is intended to be used as a surgical instrument to assist in the intra-operative orientation of acetabular cup components used with total hip arthroplasty. The device utilizes anatomic landmarks of the pelvis that are clearly identifiable on pre-operative imaging scans.|A patient-matched acetabular guide, made of polymeric material and with a patient-matched surface that is congruent to the mating acetabular surface. May be manufactured through an additive manufacturing process.|The device consists of a software component that generates a pre-operative plan based on the medical imaging data and a hardware component, the patient-matched guide that is positioned onto/within the acetabulum by mating the patient-specific contact surface to its corresponding anatomical surface. The guide is used to place an alignment pin at/near the acetabular rim in a pre-operatively desired orientation. The alignment pin is used as a visual reference to assist in the intra-operative orientation of the acetabular component during THA, so the surgeon may visually ensure that the orientation of the alignment pin matches the normal direction of the acetabular component.|Acetabulum|N|N
OR|SU|HWE|Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment|1||N|N||878.4820|4|||||N|N
OR|SU|LZN|Cement Obturator|2||N|N||878.3300|1|||||Y|N
OR|SU|OJH|Orthopedic Tray|1||N|N||878.4800|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
OR|SU|OLC|Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen|2||N|N||878.3300|1|Intended for use in surgical procedures for the repair and reinforcement of soft tissue injuries of the medial meniscus.  In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh.  In addition, the surgically prepared site must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.    The device reinforces soft tissue and provides a resorbable scaffold that is replaced by the patients own soft tissue.  The device is not a prosthetic device and is not intended to replace normal body structure.|The device is provided in one configuration: a semi-lunar shape with a triangular cross-section for use in the medial meniscus.  The device is a resorbable collagen matrix composed primarily of bovine Type I collagen (~99%) derived from Achilles tendon, and small quantities of glycosaminoglycans, i.e., chondroitin sulfate (~0.04% w/w) and sodium hyaluronate (~0.08% w/w).|The device is a partially resorbable scaffold intended for the repair and reinforcement of soft tissue injuries of the medial meniscus.  For proper implantation of the device, a partial meniscectomy is performed and necessary tissue is removed to expose the red/white zone of the meniscus.  The patient must have an intact meniscal rim and anterior and posterior horns for attachment of the device.|medial meniscus|Y|N
OR||HSZ|Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment|U|1|N|N|||1|||||N|N
OR||HWF|Prosthesis, Ligament|3||N|N|||2|||||N|N
OR||JDH|Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal|N|2|N|N|||2|||||Y|N
OR||KIJ|Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment|U|1|N|N|||1|||||N|N
OR||LML|Ligaments And Tendons, Synthetic|3||N|N|||2|||||Y|N
OR||LMN|Ceramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses|3||N|N|||2|||||N|N
OR||LPF|Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented|3||N|N|||2|||||Y|N
OR||LRN|Wire, Surgical|U|1|N|N|||1|||||N|N
OR||LWA|Prosthesis, Ligament, Ptfe|3||N|N|||2|||||Y|N
OR||LXC|Monitor, Pressure, Intracompartmental|U|1|N|N|||1|||||N|N
OR||LXI|Guide, Drill, Ligament|U|1|N|N|||1|||||N|N
OR||LXY|Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer|3||N|N|||3|||||Y|N
OR||LYH|Arthrometer|U|1|N|N|||1|||||N|N
OR||LYQ|Accessories, Fixation, Spinal Intervertebral Body|U|1|N|N|||1|||||N|N
OR||LZE|Isometer|U|1|N|N|||1|||||N|N
OR||LZJ|Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained|U|1|N|N|||1|||||Y|N
OR||MBD|Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer|3||N|N|||2|||||Y|N
OR||MBJ|Fastener, Fixation, Biodegradable, Hard Tissue|3||N|N|||3|||||Y|N
OR||MCJ|Pump, Vacuum, Electric, Suction-Type Electrode|3||N|N|||3|||||N|N
OR||MCV|Spinal Pedicle Screw, Fixation, Appliance System|3||N|N|||2|||||Y|N
OR||MDI|Prosthesis, Rib Replacement|U|1|N|N|||1|In children with or at risk of developing Thoracic Insufficiency Syndrome, the expandable rib prosthesis devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow. The devices are attached perpendicularly to the subject's natural ribs and lumbar vertebra or pelvis. This mechanically stabilizes the chest wall and enlarges the thorax to improve respiration and lung growth. The devices allow assembly in a number of different configurations to accommodate the wide variety of anatomical deformities encountered by the clinician in treating patients with or at risk of developing Thoracic Insufficiency Syndrome.||||Y|N
OR||MJO|Prosthesis, Intervertebral Disc|3||N|N|||2|||||Y|N
OR||MJT|Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented|3||N|N|||3|||||Y|N
OR||MJW|Prosthesis, Subtalar, Plug, Polymer|U|1|N|N|||1|||||Y|N
OR||MOO|Orthopedic Implant Material|U|1|N|N|||1|||||Y|N
OR||MOZ|Acid, Hyaluronic, Intraarticular|3||N|N|||2|||||N|N
OR||MPK|Semi-Constrained Metal/Polymer Finger Joint Prosthesis|f||N|N|||6|||||Y|N
OR||MQO|Prosthestic Disc Nucleus Device|N|3|N|N|||3|Export only|Export Only|Export Only|Export Only|Y|N
OR||MRA|Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented|3||N|N|||2|||||Y|N
OR||MRW|System, Facet Screw Spinal Device|U|1|N|N|||1|||||Y|N
OR||MRY|Appliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component|U|1|N|N|||1|||||Y|N
OR||NBN|Generator, Shock-Wave, For Pain Relief|3||N|N|||2|||||N|N
OR||NCO|Implant, Cartilage, For Articular Cartilage Repair|3||N|N|||3|||||Y|N
OR||NEG|Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis|3||N|N|||2|Pma approved:  P000057||||Y|N
OR||NEK|Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction|3||N|N|||2|||||Y|N
OR||NJL|Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing|3||N|N|||2|This type of device is designed to allow for motion between the plastic bearing and metal baseplate components of a knee prosthesis.  It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses.||||Y|N
OR||NKG|Orthosis, Cervical Pedicle Screw Spinal Fixation|U|1|N|N|||1|This device is a posterior pedicle screw fixation system indicated for any of the following:   Cervical spondylolisthesis (all grades and types) cervical spondylosis   cervical degenerative disc disease   degeneration of the cervical facets accompanied by instability cervical trauma (fracture dislocation) revision of failed previous fusion surgery (pseudoarthrosis) of the cervical spine|metallic plates and screws|uses screws and plates to stabilize spinal segments for fusion|posterior cervical spine|Y|N
OR||NOX|Filler, Bone Void, Synthetic Peptide|3||N|N|||3|The device acts as a bone void filler and consists of a filling material and a synthetic peptide.  It is intended to fill traumatic or surgically-created defects that are not intrinsic to the bony structure of the extremities, spine or pelvis.  It will be packed or placed into the defect and will resorb over time to be replaced by bone.||||Y|Y
OR||NQO|Prosthesis, Spinous Process Spacer/Plate|3||N|N|||2|This device is an interspinous spacer or spinous process plate that is implanted between the spinous processes or attached to the spinous process.||||Y|N
OR||NRA|Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing|3||N|N|||2|This type of device is designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis.  It is intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis and avascular necrosis.||||Y|N
OR||NTG|Prosthesis, Ankle, Uncemented, Non-Constrained|3||N|N|||2|An ankle joint metal/polymer non-constrained uncemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar component made of ultra-high molecular weight polyethylene.||||Y|Y
OR||NVR|Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar|U|1|N|N|||1|Intended to be inserted between the vertebral bodies into the disc space from l3 to s1 to provide stabilization and to help promote intervertebral body fusion.  To be used with bone graft, for holding bone parts in alignment while they heal.  Not intended for use in motion-sparing, non-fusion procedures,  helps promote intervertebral body fusion.|Cobalt chrome spheres|Inserted between the vertebral bodies in the disc space.|Intervertebral disc space from L3 to S1.|Y|N
OR||NXT|Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing|3||N|N|||2|Prosthesis, hip, semi-constrained, metal/metal, resurfacing device relieves hip pain and improves hip function by replacing the parts of the hip that have been severely damaged by degenerative joint diseases.  This device is indicated for patients with degenerative joint diseases including osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, or avascular necrosis and for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint revision.|The femoral resurfacing component and acetabular components are made of metal. These surfaces rub against each other (the bearing couple) and are made from highly-polished metal. This type of bearing couple is called a metal-on-metal bearing couple.|Prosthesis, hip, semi-constrained, metal/metal, resurfacing device has two parts: a socket in the shape of a shallow cup (acetabular component), and a cap in the form of a ball head (femoral resurfacing component).  The cup replaces the damaged surface of the hip socket (acetabulum). The cap covers or resurfaces the ball-shaped bone at the top of the thigh (femoral head), and the cap has a small stem that is inserted into the top of the thighbone.  The cap moves within the cup.|The device is to replace the hip joint.|Y|N
OR||OJZ|Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde|f||N|N|||6|Device type:  Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction, revision spine surgery, autograft not available or feasible - replacement for autograft bone in patients where autograft is unavailable or not feasible to harvest.  Not feasible to harvest is intended to means presence of a condition where normal bone metabolism would be expected to prevent healing, e.G., smokers and diabetics.  Revision spine surgery to treat pseudarthrosis.|none|Product provides signal for cell differentiation and scaffold for new bone growth|spine|Y|N
OR||OKD|Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde, Long Bone Nonunion|f||N|N|||6|Bone graft substitute when autograft is unavailable or unfeasible to harvest for treatment of recalcitrant long bone non-unions where normal bone metabolism and healing is not present, e.g., smokers and diabetics.|protein solution-soaked colagen sponge or putty containing collagen and protein|used as a substitute for autograft when autograft harvesting is nt possible or not feasible|long bones, e.g., tibia|Y|N
OR||OME|Extracorporeal Shock Wave Treatment|3||N|N|||2|For use for extracorporeal shock wave treatment of atrophic nonunion fractures.  The device delivers a shock wave to the patient via a water-filled coupling membrane whic is intented to help atrophic nonunion fractures heal.|Length of arm 600/700mm, Reflecture aperture: 620-1010mm, weight: 152 kg|The device delivers a shock wave to the patient via a water-filled coupling membrane whic is intented to help atrophic nonunion fractures heal.|Bone that has an atrophic nonunion fracture|N|N
OR||OMX|High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis|f||N|N|||6|For use in arthroplasty of the proximal interphalangeal (PIP) joint when the patient: a) has soft tissue and bone that can provide adequate stabilization and fixation under high-demand loading conditions after reconstruction; and b) needs a revision of a failed PIP prosthesis, or has pain, limited motion, or joint subluxation/disloation secondary to damage or destruction of the articular cartilage.|pyrolytic carbon implant|Implant|finger joints|Y|N
OR||OVO|Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation|3||N|N|||2|Intended as a primary joint replacement prosthesis in total hip arthroplasty.|metal femoral stem, ceramic femoral head, metal acetabular liner designed to fit within a metal acetaublar shell|comprised of a metal liner designed to fit within a compatible acetabular shell which articulates with a compatible ceramic  femoral head attached to a femoral stem as part of a primary total hip joint replacement system|hip joint|Y|N
OR||PBU|Bone Void Filler, Syringe|N|3|N|N|||3|To fill bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine and pelvis).|Pre-filled syringe that contains putty composed of bioactive glass particles, polyethylene glycol and glycerol.  Syringe tip permits attachment of cannula. Syringe also includes rotating plunger to aid in controlled dispersion of device.|Extruded from syringe into bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis).|Skeletal system (extremities, posterolateral spine and pelvis).|Y|N
OR||PFM|Hemibridge System|N|3|N|N|||3|Non-fusion growth modulation of spinal column.|Metallic plate or staple with fixation elements|An antero-lateral growth plate intended to attach to vertebral bodies in order to modulate growth of the spinal column|Anterior spinal column|Y|N
OR||PGM|Growing Rod System|U|1|N|N|||1|Stabilization or correction of spinal deformities without the use of fusion.|Metalllic rods, monoaxial or polyaxial bone screws, hooks, and other related accessories.|The system of distracting or compressing rods and fixation elements (screws, hooks, etc.) provides stabilization and correction of the spine as the child grows.|Pediatric spine.|Y|N
OR||PGN|Growing Rod System- Magnetic Actuation|U|1|N|N|||1|Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod.|Metalllic rods, monoaxial or polyaxial bone screws, hooks, magnetic remote control, and other related accessories.|The system of distracting rods and fixation elements (screws, hooks, etc.) provides stabilization of severe spinal abnormalities and distraction of the rod as the child grows, via magnetic actuation.|Pediatric spine|Y|N
OR||PIX|Elbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented Prosthesis|N|3|N|N|||7|An elbow joint metal/polymer constrained uncemented prosthesis is a device intended to be implanted to replace an elbow joint.|The components have a porous coating made of Ti-6Al-4V alloy powder. The coating is further enhanced by a layer of hydroxyapatite.|The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. It is designed to achieve biological fixation to bone without the use of bone cement.|Elbow|Y|N
OR||PJY|Transfemoral Percutaneous Prosthetic|3||N|N|||6|The device is a percutaneous prosthetic device for the direct skeletal attachment of a prosthetic limb.|the device may be threaded, or coated to provide fixation to the bone. The device is made from medical grade mettalic components.|The device is implanted into the femur to allow a fixation point for standard prosthetic limbs.|Femur of amputee patients|Y|N
PA|HE|GGH|Iron Stains|1||Y|N||864.1850|4|||||N|N
PA|HE|GHZ|Solution, Gugol Blue|1||Y|N||864.1850|4|||||N|N
PA|HE|GJH|Stain, Reticulocyte|1||Y|N||864.1850|4|||||N|N
PA|HE|GJJ|Stains, Heinz Body|1||Y|N||864.1850|4|||||N|N
PA|HE|GJL|Romanowsky Stains|1||Y|N||864.1850|4|||||N|N
PA|HE|HYB|Eosin Y|1||Y|N||864.1850|4|||||N|N
PA|HE|HYC|Fast Green|1||Y|N||864.1850|4|||||N|N
PA|HE|HYD|Fast Red Salt B|1||Y|N||864.1850|4|||||N|N
PA|HE|HYE|Solution, Fontanna Silver|1||Y|N||864.1850|4|||||N|N
PA|HE|HYF|Giemsa Stain|1||Y|N||864.1850|4|||||N|N
PA|HE|HYG|Glenner'S Stain|1||Y|N||864.1850|4|||||N|N
PA|HE|HYH|Gold Chloride|1||Y|N||864.1850|4|||||N|N
PA|HE|HYI|Iodine, Grams|1||Y|N||864.1850|4|||||N|N
PA|HE|HYJ|Hematoxylin|1||Y|N||864.1850|4|||||N|N
PA|HE|HYK|Hematoxylin Harris'S|1||Y|N||864.1850|4|||||N|N
PA|HE|HYL|Hematoxylin Mayer'S|1||Y|N||864.1850|4|||||N|N
PA|HE|HYO|Hematoxylin Weigert'S|1||Y|N||864.1850|4|||||N|N
PA|HE|HYQ|Iron Chloride-Weigert|1||Y|N||864.1850|4|||||N|N
PA|HE|HYR|Leuco-Patent Blue|1||Y|N||864.1850|4|||||N|N
PA|HE|HYS|Light Green|1||Y|N||864.1850|4|||||N|N
PA|HE|HYT|Luxol Fast Blue|1||Y|N||864.1850|4|||||N|N
PA|HE|HYW|Stain, Trichrome, Mallory'S|1||Y|N||864.1850|4|||||N|N
PA|HE|HYY|Metanil Yellow|1||Y|N||864.1850|4|||||N|N
PA|HE|HYZ|Methenamine Silver|1||Y|N||864.1850|4|||||N|N
PA|HE|HZA|Methyl Green|1||Y|N||864.1850|4|||||N|N
PA|HE|HZC|Mucicarmine|1||Y|N||864.1850|4|||||N|N
PA|HE|HZD|Muller'S Colloidal Iron|1||Y|N||864.1850|4|||||N|N
PA|HE|HZE|Nile Blue|1||Y|N||864.1850|4|||||N|N
PA|HE|HZF|Nuclear Fast Red|1||Y|N||864.1850|4|||||N|N
PA|HE|HZG|Oil Red O|1||Y|N||864.1850|4|||||N|N
PA|HE|HZH|Orange G|1||Y|N||864.1850|4|||||N|N
PA|HE|HZJ|Stain, Papanicolau|1||Y|N||864.1850|4|||||N|N
PA|HE|HZL|Phloxine B|1||Y|N||864.1850|4|||||N|N
PA|HE|HZM|Hematoxylin, Acid, Phosphotungstic|1||Y|N||864.1850|4|||||N|N
PA|HE|HZN|Picro Methyl Blue|1||Y|N||864.1850|4|||||N|N
PA|HE|HZO|Stain, Ponceau|1||Y|N||864.1850|4|||||N|N
PA|HE|HZP|Pyronin|1||Y|N||864.1850|4|||||N|N
PA|HE|HZQ|Red-Violet Lb|1||Y|N||864.1850|4|||||N|N
PA|HE|HZR|Resorcin Fuchsin|1||Y|N||864.1850|4|||||N|N
PA|HE|HZS|Safranin|1||Y|N||864.1850|4|||||N|N
PA|HE|HZT|Reagent, Schiff|1||Y|N||864.1850|4|||||N|N
PA|HE|HZX|Silver Nitrate|1||Y|N||864.1850|4|||||N|N
PA|HE|HZY|Sirius Red|1||Y|N||864.1850|4|||||N|N
PA|HE|HZZ|Sudan Black B|1||Y|N||864.1850|4|||||N|N
PA|HE|IAA|Titan Yellow|1||Y|N||864.1850|4|||||N|N
PA|HE|IAB|Toluidine Blue|1||Y|N||864.1850|4|||||N|N
PA|HE|IAC|Van Gieson'S Stain|1||Y|N||864.1850|4|||||N|N
PA|HE|IAD|Van Gieson'S Picro-Fuchsin|1||Y|N||864.1850|4|||||N|N
PA|HE|IAE|Hematoxylin, Iron, Weigert'S|1||Y|N||864.1850|4|||||N|N
PA|HE|IAF|Wright'S Stain|1||Y|N||864.1850|4|||||N|N
PA|HE|ICC|Eosin B|1||Y|N||864.1850|4|||||N|N
PA|HE|ICD|Darrow Red|1||Y|N||864.1850|4|||||N|N
PA|HE|ICF|Crystal Violet For Histology|1||Y|N||864.1850|4|||||N|N
PA|HE|ICG|Cresyl Violet Acetate|1||Y|N||864.1850|4|||||N|N
PA|HE|ICH|Congo Red|1||Y|N||864.1850|4|||||N|N
PA|HE|ICI|Hematoxylin, Chrome Alum|1||Y|N||864.1850|4|||||N|N
PA|HE|ICJ|Carbol Night Blue|1||Y|N||864.1850|4|||||N|N
PA|HE|ICL|Carbol Fuchsin|1||Y|N||864.1850|4|||||N|N
PA|HE|ICM|Brilliant Yellow|1||Y|N||864.1850|4|||||N|N
PA|HE|ICN|Biebrich Scarlet|1||Y|N||864.1850|4|||||N|N
PA|HE|ICO|Best'S Carmine|1||Y|N||864.1850|4|||||N|N
PA|HE|ICQ|Azure A|1||Y|N||864.1850|4|||||N|N
PA|HE|ICR|Azocarmine B|1||Y|N||864.1850|4|||||N|N
PA|HE|ICS|Azocarmine G|1||Y|N||864.1850|4|||||N|N
PA|HE|ICT|Azan Counterstain|1||Y|N||864.1850|4|||||N|N
PA|HE|ICX|Aniline|1||Y|N||864.1850|4|||||N|N
PA|HE|ICY|Acid, Aniline, Fuchsin|1||Y|N||864.1850|4|||||N|N
PA|HE|ICZ|Ammoniacal Silver Hydroxide Silver Nitrate|1||Y|N||864.1850|4|||||N|N
PA|HE|IDA|Alcian Blue|1||Y|N||864.1850|4|||||N|N
PA|HE|IDB|Aldehyde Fuchsin|1||Y|N||864.1850|4|||||N|N
PA|HE|IDC|Acridine Orange|1||Y|N||864.1850|4|||||N|N
PA|HE|IDD|Alizarin Red|1||Y|N||864.1850|4|||||N|N
PA|HE|IDE|Acid, Hematein|1||Y|N||864.1850|4|||||N|N
PA|HE|IDF|Acid, Fuchsin|1||Y|N||864.1850|4|||||N|N
PA|HE|JCH|Esterase|1||Y|N||864.1850|4|||||N|N
PA|HE|JCI|Acid Phosphatase, Cytochemical|1||Y|N||864.1850|4|||||N|N
PA|HE|JTS|Stains, Microbiologic|1||Y|N||864.1850|4|||||N|N
PA|HE|KFC|Methylene Blue, Tissue Stain|1||Y|N||864.1850|4|||||N|N
PA|HE|KFD|Aniline Blue|1||Y|N||864.1850|4|||||N|N
PA|HE|KFE|Neutral Red|1||Y|N||864.1850|4|||||N|N
PA|HE|KIP|Formulations, Balanced Salt Solutions|1||N|N||864.2875|4|||||N|N
PA|HE|KIQ|Kit, Culture, Chromosome|1||N|N||864.2260|4|||||N|N
PA|HE|KIR|Cells, Animal And Human, Cultured|1||N|N||864.2280|4|||||N|N
PA|HE|KIS|Sera, Animal And Human|1||N|N||864.2800|4|||||N|N
PA|HE|KIT|Media And Components, Synthetic Cell And Tissue Culture|1||N|N||864.2220|4|||||N|N
PA|HE|KIW|Kit, Mycoplasma Detection|1||N|N||864.2360|4|||||N|N
PA|HE|KIX|Media, Mycoplasma Detection|1||N|N||864.2360|4|||||N|N
PA|HE|KIY|Chamber, Slide Culture|1||Y|N||864.2240|4|||||N|N
PA|HE|KIZ|Dish, Tissue Culture|1||Y|N||864.2240|4|||||N|N
PA|HE|KJA|Flask, Tissue Culture|1||Y|N||864.2240|4|||||N|N
PA|HE|KJB|Apparatus, Roller|1||Y|N||864.2240|4|||||N|N
PA|HE|KJC|Bottle, Roller, Tissue Culture|1||Y|N||864.2240|4|||||N|N
PA|HE|KJD|Spinner, Flask|1||Y|N||864.2240|4|||||N|N
PA|HE|KJE|Spinner System, Cell Culture|1||Y|N||864.2240|4|||||N|N
PA|HE|KJF|System, Suspension, Cell Culture|1||Y|N||864.2240|4|||||N|N
PA|HE|KJH|Apparatus, Perfusion|1||Y|N||864.2240|4|||||N|N
PA|HE|KJK|Auramine O|1||Y|N||864.1850|4|||||N|N
PA|HE|KJL|Azure C|1||Y|N||864.1850|4|||||N|N
PA|HE|KJM|Bismarck Brown Y|1||Y|N||864.1850|4|||||N|N
PA|HE|KJN|Brilliant Cresyl Blue|1||Y|N||864.1850|4|||||N|N
PA|HE|KJO|Brilliant Green|1||Y|N||864.1850|4|||||N|N
PA|HE|KJP|Carmine|1||Y|N||864.1850|4|||||N|N
PA|HE|KJQ|Chlorazol Black E|1||Y|N||864.1850|4|||||N|N
PA|HE|KJR|Erythrosin B|1||Y|N||864.1850|4|||||N|N
PA|HE|KJS|Ethyl Eosin|1||Y|N||864.1850|4|||||N|N
PA|HE|KJT|Indigocarmine|1||Y|N||864.1850|4|||||N|N
PA|HE|KJW|Janus Green B|1||Y|N||864.1850|4|||||N|N
PA|HE|KJX|Jenner Stain|1||Y|N||864.1850|4|||||N|N
PA|HE|KJY|Malachite Green|1||Y|N||864.1850|4|||||N|N
PA|HE|KJZ|Martius Yellow|1||Y|N||864.1850|4|||||N|N
PA|HE|KKA|Methyl Orange|1||Y|N||864.1850|4|||||N|N
PA|HE|KKB|Methyl Violet 2b|1||Y|N||864.1850|4|||||N|N
PA|HE|KKC|Methylene Violet|1||Y|N||864.1850|4|||||N|N
PA|HE|KKD|Nigrosin|1||Y|N||864.1850|4|||||N|N
PA|HE|KKE|Orange Ii|1||Y|N||864.1850|4|||||N|N
PA|HE|KKF|Orcein|1||Y|N||864.1850|4|||||N|N
PA|HE|KKG|Protargol S|1||Y|N||864.1850|4|||||N|N
PA|HE|KKH|Tablet, Resazurin|1||Y|N||864.1850|4|||||N|N
PA|HE|KKI|Rose Bengal|1||Y|N||864.1850|4|||||N|N
PA|HE|KKJ|Sudan Iii|1||Y|N||864.1850|4|||||N|N
PA|HE|KKK|Sudan Iv|1||Y|N||864.1850|4|||||N|N
PA|HE|KKL|Thionin|1||Y|N||864.1850|4|||||N|N
PA|HE|KKM|Methylene Blue Thiocyanate|1||Y|N||864.1850|4|||||N|N
PA|HE|KKP|Solution, Silver Carbonate|1||Y|N||864.1850|4|||||N|N
PA|HE|KKQ|Sodium Periodate|1||Y|N||864.1850|4|||||N|N
PA|HE|KKR|Potassium Periodate|1||Y|N||864.1850|4|||||N|N
PA|HE|KKS|Acid, Periodic|1||Y|N||864.1850|4|||||N|N
PA|HE|KKT|Hematoxylin, Ehrlich'S|1||Y|N||864.1850|4|||||N|N
PA|HE|KKW|Basic Fuchsin|1||Y|N||864.1850|4|||||N|N
PA|HE|KPB|Media And Components, Mycoplasma Detection|1||N|N||864.2360|4|||||N|N
PA|HE|KQC|Stains, Hematology|1||Y|N||864.1850|4|||||N|N
PA|HE|LED|Stains, Chemical Solution|1||Y|N||864.1850|4|||||N|N
PA|HE|LEE|Stains, Dye Solution|1||Y|N||864.1850|4|||||N|N
PA|HE|LEF|Stains, Dye Powder|1||Y|N||864.1850|4|||||N|N
PA|HE|LGY|Trypan Blue|1||Y|N||864.1850|4|||||N|N
PA|HE|LKM|Counter, Urine Particle|2||N|N||864.5200|1|||||N|N
PA|HE|LNJ|Analyzer, Chromosome, Automated|2||N|P||864.5260|1|||||N|N
PA|HE|MXZ|Immunohistochemistry Assay,Antibody,Progesterone Receptor|2||N|Y||864.1860|1|||||N|N
PA|HE|MYA|Immunohistochemistry Antibody Assay, Estrogen Receptor|2||N|Y||864.1860|1|||||N|N
PA|HE|NBK|System,Test,(Ihc),Tumor Marker,Monitoring,Bladder Cancer|2||N|Y||864.1860|1|||||N|N
PA|HE|NJT|Immunohistochemistry Reagents And Kits|1||N|N||864.1860|4|according to the regs..."..used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin.||||N|N
PA|HE|NJW|Control Material, Her-2/Neu, Immunohistochemistry|2||N|N||864.1860|1|Accessory to immunohistochemistry assays for Her2-neu.  Control material intended for laboratory use to control Her2-neu immunohistochemistry assays.||||N|N
PA|HE|NKF|Immunohistochemistry Antibody Assay, C-Kit|3||N|N||864.1860|2|Identification/Intended Use - The anti-c-KIT primary antibody is intended for laboratory use, via light microscopy, for the qualitative detection of KIT protein in formalin-fixed, paraffin-embedded gastrointestinal stromal tumors (GISTs) using either an automated immunohistochemistry staining system or manual assay. It is indicated as an aid in the selection of GIST patients who may qualify for imatinib mesylate therapy within the context of the patient's clinical history, tumor morphology, and other diagnostic tests evaluated by a qualified pathologist. The test is not intended as the sole basis for making the diagnosis of GIST and is not intended as the sole basis for selecting imatinib mesylate therapy.  A negative result would not necessarily exclude the diagnosis of GIST||||N|N
PA|HE|NOT|Microscope, Automated, Image Analysis, Operator Intervention|2||N|N||864.1860|1|Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention.||||N|N
PA|HE|NQF|Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor|3||N|N||864.1860|2|The epidermal growth factor receptor (EGFR) antibody/assay is a qualitative immunohistochemical antibody/assay to identify EGFR expression in normal and neoplastic tissues routinely-fixed for histological evaluation.  EGFR antibody/assay specifically detects the EGFR (HER1) protein in EGFR-expressing cells.  This antibody/assay is indicated as an aid in identifying colorectal cancer patients eligible for treatment with cetuximab, a monoclonal antibody drug.    This will be a specialized subcategory for EGFR immunohistochemistry assays under the general heading of the regulation for all Immunohistochemistry assays.||||N|N
PA|HE|NQN|Microscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity|2||N|N||864.1860|1|Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.||||N|N
PA|HE|NTR|Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells|1||N|N||864.1860|4|MONOCLONAL OR POLYCLONAL ANTIBODY THAT RECOGNIZES THE HUMAN P63 PROTEIN IN THE NUCLEUS OF PROSTATIC BASAL CELLS USING ROUTINE IMMUNOHISTOCHEMICAL TECHNIQUES, INCLUDING HEAT-INDUCED ANTIGEN EPITOPE RETRIEVAL. THIS TEST IS INTENDED FOR LABORATORY USE TO QUALITATIVELY IDENTIFY THE P63 ANTIGEN IN HISTOLOGICAL SECTIONS FROM FORMALIN-FIXED PARAFFIN-EMBEDDED SAMPLES OF NORMAL AND/OR PATHOLOGICAL PROSTATE TISSUE OBTAINED BY NEEDLE BIOPSY OR SURGICAL PROCEDURES. THE PRESENCE OR ABSENCE OF P63 STAINING AIDS THE PATHOLOGIST IN THE DIFFERENTIAL DIAGNOSIS OF PROSTATE CANCER IN CONJUNCTION WITH MORPHOLOGICAL FINDINGS SEEN WITH HEMATOXYLIN AND EOSIN STAINING COMPLEMENTED BY PROPER CONTROLS.||||N|N
PA|HE|OEO|Automated Digital Image Manual Interpretation Microscope|2||N|N||864.1860|1|The ihc her2 manual read of a digital slide application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of her2/neu (c-erbb-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for her-2 receptors, using microscopy images displayed on a computer monitor.  Her-2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes in breast cancer.|automated digital microscope slide scanner, computer, color monitor, keyboard and digital pathology information management software|Digital microscopy image of stained tissue on a microscope slide, used to determine HER2 IHC status|Immunohistochemical stained microscope slides|N|N
PA|HE|PLS|Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1|3||N|N||864.1860|2|The programmed death-ligand 1 (PD-L1) antibody is a qualitative immunohistochemical antibody intended to identify PD-L1 protein expression in human clinical tissue specimens.  The PD-L1 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs or to assess PD-L1 expression level in patients who may respond particularly well to specific FDA approved therapeutic drugs.|The device includes a monoclonal primary antibody and accessory reagents, including secondary antibodies, buffers, substrates, and counterstains.  The device may be intended for manual or automated staining methods.|The test uses a primary monoclonal antibody to detect the presence of expressed antigen protein in fixed tissue specimens.  Antibody-antigen complexes are visualized using an enzyme conjugated primary or secondary antibody to catalyze a color-producing reaction.|Human clinical tissue specimens|N|N
PA|IM|NQI|System, Immunomagnetic, Circulating Cancer Cell, Enumeration|2||N|N||866.6020|1|In vitro diagnostic device to aid in the enumeration of immunomagnetically selected and fluorescently identified circulating tumor cells of epithelial origin in whole blood for prediction of cancer progression and survival.||||N|N
PA|IM|PKB|Autosomal Recessive Carrier Screening Gene Mutation Detection System|2||N|N||866.5940|1|Autosomal recessive carrier screening gene mutation detection system is a qualitative in vitro molecular diagnostic system used for genotyping of clinically relevant variants in genomic DNA isolated from human peripheral whole blood or saliva specimens  intended for prescription use or over-the-counter use. The device is intended for autosomal recessive disease carrier screening in adults of reproductive age. The device is not intended for copy number variation, cytogenetic, or biochemical testing.|Multiplex microarray based detection system|Microarray based method to detect genomic DNA mutations|human clinical specimens|N|N
PA|PA|HZI|Acid, Osmic|1||Y|N||864.4010|4|||||N|N
PA|PA|IAL|Iodine (Tincture)|1||Y|N||864.4010|4|||||N|N
PA|PA|IAM|Solution, Lugol'S|1||Y|N||864.4010|4|||||N|N
PA|PA|IAT|Syrup, Gum, Apathy'S|1||Y|N||864.4010|4|||||N|N
PA|PA|IAW|Collodion|1||Y|N||864.4010|4|||||N|N
PA|PA|IAY|Colchicine|1||Y|N||864.4010|4|||||N|N
PA|PA|IAZ|Heparin|1||N|N||864.4400|4|||||N|N
PA|PA|IBA|Streptolysin O|1||N|N||864.4400|4|||||N|N
PA|PA|IBB|Phytohemaglutinin M|1||Y|N||864.4010|4|||||N|N
PA|PA|IBC|Diastase|1||N|N||864.4400|4|||||N|N
PA|PA|IBD|Hyaluronidase|1||N|N||864.4400|4|||||N|N
PA|PA|IBE|Neuramininase (Sialidase)|1||N|N||864.4400|4|||||N|N
PA|PA|IBF|Papain|1||N|N||864.4400|4|||||N|N
PA|PA|IBG|Trypsin|1||N|N||864.4400|4|||||N|N
PA|PA|IBJ|Light, Microscope|1||Y|N||864.3600|4|||||N|N
PA|PA|IBK|Microscope, Fluorescence/U.V.|1||Y|N||864.3600|4|||||N|N
PA|PA|IBL|Microscope, Inverted Stage, Tissue Culture|1||Y|N||864.3600|4|||||N|N
PA|PA|IBM|Microscope, Phase Contrast|1||Y|N||864.3600|4|||||N|N
PA|PA|IDL|Microtome, Accessories|1||Y|N||864.3010|4|||||N|N
PA|PA|IDM|Microtome, Ultra|1||Y|N||864.3010|4|||||N|N
PA|PA|IDN|Microtome, Freezing Attachment|1||Y|N||864.3010|4|||||N|N
PA|PA|IDO|Microtome, Rotary|1||Y|N||864.3010|4|||||N|N
PA|PA|IDP|Microtome, Cryostat|1||Y|N||864.3010|4|||||N|N
PA|PA|IDQ|Infiltrator|1||Y|N||864.3010|4|||||N|N
PA|PA|IDR|Ovens, Paraffin|1||Y|N||864.3010|4|||||N|N
PA|PA|IDS|Melting Pot, Paraffin|1||Y|N||864.3010|4|||||N|N
PA|PA|IDT|Apparatus, Melting Point, Paraffin|1||Y|N||864.3010|4|||||N|N
PA|PA|IDW|Dispensers, Paraffin|1||Y|N||864.3010|4|||||N|N
PA|PA|IDX|Sieves, Tissue|1||Y|N||864.3010|4|||||N|N
PA|PA|IDY|Bath, Flotation, Tissue|1||Y|N||864.3010|4|||||N|N
PA|PA|IDZ|Cassettes, Tissue|1||Y|N||864.3010|4|||||N|N
PA|PA|IEG|Table, Slide Warming|1||Y|N||864.3010|4|||||N|N
PA|PA|IEH|Lamps, Slide Warming|1||Y|N||864.3010|4|||||N|N
PA|PA|IEO|Processor, Tissue, Automated|1||N|N||864.3875|4|||||N|N
PA|PA|IER|Polyethylene Glycol (Carbowax)|1||Y|N||864.4010|4|||||N|N
PA|PA|IEX|Gelatin|1||Y|N||864.4010|4|||||N|N
PA|PA|IEZ|Celloidin|1||Y|N||864.4010|4|||||N|N
PA|PA|IFB|Cytocentrifuge|1||N|N||864.3300|4|||||N|N
PA|PA|IFF|Solution, Decalcifier, Electrolytic|1||Y|N||864.4010|4|||||N|N
PA|PA|IFH|Solution, Zenker'S|1||Y|N||864.4010|4|||||N|N
PA|PA|IFI|Sprays, Synthetic, Smear|1||Y|N||864.4010|4|||||N|N
PA|PA|IFJ|Fixative, Richardson Glycol|1||Y|N||864.4010|4|||||N|N
PA|PA|IFL|Polyethylene Glycol Preservative|1||Y|N||864.4010|4|||||N|N
PA|PA|IFN|Solution, Orth'S|1||Y|N||864.4010|4|||||N|N
PA|PA|IFO|Solution, Newcomer'S|1||Y|N||864.4010|4|||||N|N
PA|PA|IFP|Formalin, Neutral Buffered|1||Y|N||864.4010|4|||||N|N
PA|PA|IFQ|Formulations, Mercuric Chloride For Tissue|1||Y|N||864.4010|4|||||N|N
PA|PA|IFS|Solution, Helly|1||Y|N||864.4010|4|||||N|N
PA|PA|IFT|Glutaraldehyde|1||Y|N||864.4010|4|||||N|N
PA|PA|IFY|Gelatin-Formalin|1||Y|N||864.4010|4|||||N|N
PA|PA|IFZ|Gelatin For Specimen Adhesion|1||Y|N||864.4010|4|||||N|N
PA|PA|IGB|Solution, Formalin-Sodium Acetate|1||Y|N||864.4010|4|||||N|N
PA|PA|IGC|Formalin-Saline|1||Y|N||864.4010|4|||||N|N
PA|PA|IGD|Solution, Formol Calcium|1||Y|N||864.4010|4|||||N|N
PA|PA|IGE|Solution, Formalin Ammonium Bromide|1||Y|N||864.4010|4|||||N|N
PA|PA|IGF|Solution, Formalin-Alcohol-Acetic Acid|1||Y|N||864.4010|4|||||N|N
PA|PA|IGG|Formaldehyde (Formalin, Formol)|1||Y|N||864.4010|4|||||N|N
PA|PA|IGK|Solution, Clarke'S|1||Y|N||864.4010|4|||||N|N
PA|PA|IGM|Solution, Carnoy'S|1||Y|N||864.4010|4|||||N|N
PA|PA|IGN|Fluid, Bouin'S|1||Y|N||864.4010|4|||||N|N
PA|PA|IHJ|Blender, Sputum|1||Y|N||864.3010|4|||||N|N
PA|PA|IJZ|Oil, Clearing|1||Y|N||864.4010|4|||||N|N
PA|PA|JCB|Detergent|1||Y|N||864.4010|4|||||N|N
PA|PA|JCC|Ph Buffer|1||Y|N||864.4010|4|||||N|N
PA|PA|JCE|Solution, Isotonic|1||Y|N||864.4010|4|||||N|N
PA|PA|KDT|Container, Specimen Mailer And Storage, Sterile|1||N|N||864.3250|4|||||N|N
PA|PA|KDW|Container, Specimen Mailer And Storage, Temperature Controlled, Sterile|1||N|N||864.3250|4|||||N|N
PA|PA|KDX|Solution, Decalcifier, Acid Containing|1||Y|N||864.4010|4|||||N|N
PA|PA|KDY|Agent, Chelating For Decalcification|1||Y|N||864.4010|4|||||N|N
PA|PA|KDZ|Device, Decalcifier, Electrolytic|1||Y|N||864.3010|4|||||N|N
PA|PA|KEE|Osmium Tetroxide|1||Y|N||864.4010|4|||||N|N
PA|PA|KEF|Paraformaldehyde|1||Y|N||864.4010|4|||||N|N
PA|PA|KEG|Lamps, Microscope|1||Y|N||864.3600|4|||||N|N
PA|PA|KEH|Micrometers, Microscope|1||Y|N||864.3600|4|||||N|N
PA|PA|KEI|Condensers, Microscope|1||Y|N||864.3600|4|||||N|N
PA|PA|KEJ|Stages, Microscope|1||Y|N||864.3600|4|||||N|N
PA|PA|KEL|Adhesive, Albumin-Based|1||Y|N||864.4010|4|||||N|N
PA|PA|KEM|Agent, Clearing|1||Y|N||864.4010|4|||||N|N
PA|PA|KEO|Formulations, Paraffin, All|1||Y|N||864.4010|4|||||N|N
PA|PA|KEP|Media, Mounting, Oil Soluble|1||Y|N||864.4010|4|||||N|N
PA|PA|KEQ|Media, Mounting, Water Soluble|1||Y|N||864.4010|4|||||N|N
PA|PA|KER|Container, Embedding|1||Y|N||864.3010|4|||||N|N
PA|PA|KES|Coverslips, Microscope Slide|1||Y|N||864.3010|4|||||N|N
PA|PA|KET|Filters, Cell Collection, Tissue Processing|1||Y|N||864.3010|4|||||N|N
PA|PA|KEW|Slides, Microscope|1||Y|N||864.3010|4|||||N|N
PA|PA|KEY|Stainer, Tissue, Automated|1||N|N||864.3800|4|||||N|N
PA|PA|KFL|Microtome, Sliding|1||Y|N||864.3010|4|||||N|N
PA|PA|KIM|Device For Sealing Microsections|1||N|N||864.3400|4|||||N|N
PA|PA|KIN|Slide Stainer, Contact Type|1||N|N||864.3800|4|||||N|N
PA|PA|KIO|Slide Stainer, Immersion Type|1||N|N||864.3800|4|||||N|N
PA|PA|KJG|Tube, Tissue Culture|1||Y|N||864.3010|4|||||N|N
PA|PA|KPA|Slide Stainer, Automated|1||N|N||864.3800|4|||||N|N
PA|PA|LDT|Reagent, General Purpose|1||Y|N||864.4010|4|||||N|N
PA|PA|LDW|Fixative, Acid Containing|1||Y|N||864.4010|4|||||N|N
PA|PA|LDX|Fixative, Metallic Containing|1||Y|N||864.4010|4|||||N|N
PA|PA|LDY|Fixative, Formalin-Containing|1||Y|N||864.4010|4|||||N|N
PA|PA|LDZ|Fixative, Alcohol Containing|1||Y|N||864.4010|4|||||N|N
PA|PA|LEA|Preservative, Cytological|1||Y|N||864.4010|4|||||N|N
PA|PA|LEB|Mounting Media|1||Y|N||864.4010|4|||||N|N
PA|PA|LEC|Grinder, Tissue|1||Y|N||864.3010|4|||||N|N
PA|PA|LIJ|Peroxidase Anti-Peroxidase Immunohistochemical Stain|1||N|N||864.4400|4|||||N|N
PA|PA|MJI|Specimen/Tissue, Identification Orientation|1||Y|N||864.3010|4|||||N|N
PA|PA|NNK|Container, Specimen Mailer And Storage, Non-Sterile|1||Y|N||864.3250|4|||||N|N
PA|PA|NNL|Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile|1||Y|N||864.3250|4|||||N|N
PA||MAO|Dna-Probe, Human Chromosome|U|1|N|N|||1|||||N|N
PA||MKQ|Processor, Cervical Cytology Slide, Automated|3||N|N|||2|It is a system that is used to collect and prepare cervical cytology specimens for Pap stain-based screening for cervical cancer.  The specimens are collected and rinsed into a liquid preservative fluid from which they are then automatically filtered and deposited in a thin-layer on a glass microscope slide.  They are stained and screened by a cytotechnologist and cytopathologist.||||N|N
PA||MNM|Reader, Cervical Cytology Slide, Automated|3||N|N|||2|||||N|N
PA||MVC|System, Test, Her-2/Neu, Ihc|3||N|N|||2|||||N|N
PA||OTU|Research Use Only/Pathology|N|6|Y|N|||7|For research use only and for products imported into the US only.|N/A|N/A|N/A|N|N
PA||OWE|Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement|3||N|N|||2|Anaplastic lymphoma kinase (ALK) fluorescence in situ hybridization (FISH) kit is to detect rearrangements involving the ALK gene in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens.  It is indicated to aid in the selection of patients for treatment with specific FDA approved therapeutic drugs.|Probe and accessory assay kits contains pre-treatment solution, ALK dual color break apart probe mix, buffers, counter stain, and fluorescence mounting medium|Fluorescence in situ hybridization, manual method|Formalin-fixed, paraffin-embedded human non-small cell lung cancer tissue specimen|N|N
PA||PDD|Investigational Use Only - Pathology|N|6|Y|N|||7|Investigational use only and for products imported into the US only.|N/A|N/A|N/A|N|N
PA||PFU|Tissue Processing Kit|N|6|N|N|||7|For the preparation of human tissue specimens for frozen sectioning and histological examination.|Freezing device, heat sink and a chuck with embeddign mold|The freezing device and heat sink are housed in an insulated box and the entire kit would be used at the dissecting bench, allowing users to freeze the sample for future cutting or slicing.|Any human tissue|N|N
PA||PHP|System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection|3||N|N|||2|The colorectal neoplasia DNA methylation and hemoglobin detection system is a qualitative, non-invasive device used to screen for the detection of methylation of specific DNA markers associated with colorectal cancer and for the presence of occult hemoglobin in human specimens, including stool, blood, urine, and buccal swabs.  It is intended as an aid in the detection of colorectal cancer or advanced adenomas in conjunction with diagnostic colonoscopy.  It is indicated for use in adults 50 years or older, who are typical average-risk candidates for colorectal cancer (CRC) screening.|The device may be intended for manual or automated assay preparation.  It may include specimen collection and preparation kits or reagents, and may utilize an algorithm for result determination.|The test uses bisulfite conversion of methylated DNA and polymerase chain reaction to detect methylation of specific DNA markers, and enzymatic detection is used to detect occult hemoglobin.|human stool, blood, plasma|N|N
PA||PJG|Cancer-Related Germline Gene Mutation Detection System|3||N|N|||2|The germline gene mutation test system is an in vitro diagnostic nucleic acid amplification and detection system for the identification of genetic mutations in DNA extracted from human clinical specimens.|Test consists of reagents, instrumentation, software and instructions needed to perform the test method.|In vitro amplification and detection of genomic DNA representing a cancer-related germline gene mutation from a clinical specimen of interest|Human peripheral whole blood or clinical samples|N|N
PA||PKW|Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase|3||N|N|||2|The anaplastic lymphoma kinase (ALK) antibody is a qualitative immunohistochemical antibody intended to identify ALK protein expression in human clinical tissue specimens.  The ALK antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.|The device includes a monoclonal primary antibody and accessory reagents, including secondary antibodies, buffers, substrates, and counterstains.  The device may be intended for manual or automated staining methods.|The test uses a primary monoclonal antibody to detect the presence of expressed antigen protein in fixed tissue specimens.  Antibody-antigen complexes are visualized using an enzyme conjugated primary or secondary antibody to catalyze a color-producing reaction.|Human clinical tissue specimens.|N|N
PM|NE|GZC|Stimulator, Neuromuscular, Implanted|3||N|N||882.5860|2|Call for PMAs to be filed by 7/13/99 per 64 FR 18329 on 4/14/99||||Y|N
PM|NE|OBP|Transcranial Magnetic Stimulator|2||N|N||882.5805|1|A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder.|Hardware (a treatment chair and head support, a console and gantry), a touch screen graphic user interface (GUI), system processor and power modules, a magnetic coil (Coil) and gantry, and Coil interface electronics) and software (to provide user interface, control various subsystems.|A device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex.|Cerebral cortex|N|N
PM|NE|OVP|Vibratory Counter-Stimulation|2||N|N||882.5895|1|A vibratory counter-stimulation device is a prescription device that provides electrically powered mechanical vibration to improve the quality of sleep in patients with primary Restless Legs Syndrome.|vibrating pad|Applies a mechanical vibration to the lower legs|Lower legs|N|N
PM|OR|MBP|Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)|2||N|N||888.3045|1|||||Y|N
PM|PM|BXB|Exerciser, Powered|1||N|N||890.5380|4|||||N|N
PM|PM|EGJ|Device, Iontophoresis, Other Uses|3||N|N||890.5525|1|||||N|N
PM|PM|HPH|Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat|3||N|N||890.5275|2|PMAs to be filed by 7/13/99 (64 FR 18331 (4/14/99))||||N|N
PM|PM|IKD|Cable, Electrode|2||N|N||890.1175|4|||||N|N
PM|PM|IKE|Transducer, Miniature Pressure|1||N|N||890.1615|4|||||N|N
PM|PM|IKK|System, Isokinetic Testing And Evaluation|2||N|N||890.1925|4|||||N|N
PM|PM|IKO|Hammer, Reflex, Powered|2||N|P||890.1450|4|||||N|N
PM|PM|IKP|Chronaximeter|2||N|P||890.1225|1|||||N|N
PM|PM|IKW|Utensil, Homemaking|1||Y|N||890.5050|4|||||N|N
PM|PM|IKX|Aid, Transfer|1||Y|N||890.5050|4|||||N|N
PM|PM|IKZ|Bed, Patient Rotation, Powered|2||N|N||890.5225|4|||||N|N
PM|PM|ILC|Utensil, Eating|1||Y|N||890.5050|4|||||N|N
PM|PM|ILD|Adaptor, Dressing|1||Y|N||890.5050|4|||||N|N
PM|PM|ILE|Sling, Arm, Overhead Supported|1||Y|N||890.3475|4|||||N|N
PM|PM|ILG|Stocking, Elastic|1||Y|N||890.3475|4|||||N|N
PM|PM|ILH|Splint, Hand, And Components|1||Y|N||890.3475|4|||||N|N
PM|PM|ILI|Sling, Arm|1||Y|N||890.3640|4|||||N|N
PM|PM|ILJ|Bath, Hydro-Massage|2||N|Y||890.5100|4|||||N|N
PM|PM|ILK|Transport, Patient, Powered|2||N|P||890.5150|1|||||N|N
PM|PM|ILM|Bath, Sitz, Powered|2||N|Y||890.5100|4|||||N|N
PM|PM|ILO|Pack, Hot Or Cold, Water Circulating|2||N|N||890.5720|4|||||N|N
PM|PM|ILP|System, Communication, Non-Powered|1||Y|N||890.3700|4|||||N|N
PM|PM|ILQ|System, Communication, Powered|2||N|N||890.3710|4|||||N|N
PM|PM|ILS|Adaptor, Hygiene|1||Y|N||890.5050|4|||||N|N
PM|PM|ILT|Adaptor, Recreational|1||Y|N||890.5050|4|||||N|N
PM|PM|ILW|Adaptor, Grooming|1||Y|N||890.5050|4|||||N|N
PM|PM|ILX|Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat|3||N|N||890.5290|1|||||N|N
PM|PM|ILY|Lamp, Infrared, Therapeutic Heating|2||N|Y||890.5500|1|||||N|N
PM|PM|ILZ|Accessories, Traction|1||Y|N||890.5925|4|||||N|N
PM|PM|IMA|Pack, Heat, Moist|1||Y|N||890.5730|4|||||N|N
PM|PM|IMB|Cabinet, Moist Steam|2||N|P||890.5250|1|||||N|N
PM|PM|IMC|Bath, Paraffin|2||N|P||890.5110|4|||||N|N
PM|PM|IMD|Pack, Hot Or Cold, Disposable|1||N|Y|M|890.5710|4|||||N|N
PM|PM|IME|Pack, Hot Or Cold, Reuseable|1||Y|N||890.5700|4|||||N|N
PM|PM|IMF|Unit, Chilling|1||N|N||890.5940|4|||||N|N
PM|PM|IMG|Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat|2||N|P||890.5860|1|||||N|N
PM|PM|IMI|Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat|2||N|P||890.5300|1|||||N|N
PM|PM|IMJ|Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat|2||N|P||890.5290|1|||||N|N
PM|PM|IMK|Wheelchair, Stair Climbing|2||N|N||890.3890|1|PMA To Be Filed by 7/12/00 (65 FR 19834 (4/13/00))||||N|N
PM|PM|IML|Armrest, Wheelchair|1||N|N||890.3920|4|||||N|N
PM|PM|IMM|Footrest, Wheelchair|1||N|N||890.3920|4|||||N|N
PM|PM|IMN|Climber, Curb, Wheelchair|1||N|N||890.3920|4|||||N|N
PM|PM|IMO|Handrim, Wheelchair|1||N|N||890.3920|4|||||N|N
PM|PM|IMP|Cushion, Wheelchair|1||N|N||890.3920|4|||||N|N
PM|PM|IMQ|Attachment, Narrowing, Wheelchair|1||N|N||890.3920|4|||||N|N
PM|PM|IMR|Device, Anti-Tip, Wheelchair|1||N|N||890.3920|4|||||N|N
PM|PM|IMS|Support, Head And Trunk, Wheelchair|1||Y|N||890.3910|4|||||N|N
PM|PM|IMW|Brake, Extension, Wheelchair|1||N|N||890.3920|4|||||N|N
PM|PM|IMX|Board, Lap, Wheelchair|1||Y|N||890.3910|4|||||N|N
PM|PM|IMY|Armboard, Wheelchair|1||Y|N||890.3910|4|||||N|N
PM|PM|IMZ|Holder, Crutch And Cane, Wheelchair|1||Y|N||890.3910|4|||||N|N
PM|PM|INA|Hill Holder, Wheelchair|1||N|N||890.3920|4|||||N|N
PM|PM|INB|Attachment, Commode, Wheelchair|1||N|N||890.3920|4|||||N|N
PM|PM|INC|Cuff, Pusher, Wheelchair|1||Y|N||890.3910|4|||||N|N
PM|PM|INE|Sling, Overhead Suspension, Wheelchair|1||Y|N||890.3910|4|||||N|N
PM|PM|INF|Scale, Platform, Wheelchair|1||Y|N||890.3940|4|||||N|N
PM|PM|ING|Elevator, Wheelchair, Portable|2||N|P||890.3930|1|A motorized lift device that is not permanently mounted in one location and that is intended for medical purposes to provide a means to move a person with impaired mobility, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).||||N|N
PM|PM|INI|Vehicle, Motorized 3-Wheeled|2||N|Y||890.3800|1|||||N|N
PM|PM|INK|Stretcher, Wheeled, Powered|2||N|P||890.3690|1|||||N|N
PM|PM|INM|Chair, With Casters|1||N|N||890.3100|4|||||N|N
PM|PM|INN|Chair, Adjustable, Mechanical|1||N|N||890.3100|4|||||N|N
PM|PM|INO|Chair, Positioning, Electric|2||N|P||890.3110|1|||||N|N
PM|PM|INP|Tips And Pads, Cane, Crutch And Walker|1||Y|N||890.3790|4|||||N|N
PM|PM|INQ|Table, Powered|1||N|N||890.3760|4|||||N|N
PM|PM|INT|Plinth|1||Y|N||890.3520|4|||||N|N
PM|PM|INW|Table, Mechanical|1||N|N||890.3750|4|||||N|N
PM|PM|INX|Bed, Air Fluidized|2||N|N||890.5160|4|||||N|N
PM|PM|INY|Bed, Patient Rotation, Manual|1||N|N||890.5180|4|||||N|N
PM|PM|IOA|Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat|2||N|P||890.5275|1|||||N|N
PM|PM|IOB|Lamp, Infrared, Non Heating|2||N|Y||890.5500|1|||||N|N
PM|PM|IOD|Components, Exercise|1||Y|N||890.5350|4|||||N|N
PM|PM|IOE|Bars, Parallel, Exercise|1||Y|N||890.5370|4|||||N|N
PM|PM|IOG|Treadmill, Mechanical|1||Y|N||890.5370|4|||||N|N
PM|PM|IOL|Treadmill, Powered|1||N|N||890.5380|4|||||N|N
PM|PM|ION|Exerciser, Non-Measuring|1||Y|N||890.5370|4|||||N|N
PM|PM|IOQ|Bed, Flotation Therapy, Powered|2||N|N||890.5170|4|||||N|N
PM|PM|IOR|Wheelchair, Mechanical|1||N|Y|M|890.3850|1|||||N|N
PM|PM|IOY|Support, Arm|1||Y|N||890.3475|4|||||N|N
PM|PM|IOZ|Splint, Abduction, Congenital Hip Dislocation|1||Y|N||890.3665|4|||||N|N
PM|PM|IPF|Stimulator, Muscle, Powered|2||N|Y||890.5850|1|||||N|N
PM|PM|IPG|Shoe, Cast|1||Y|N||890.3025|4|||||N|N
PM|PM|IPL|Wheelchair, Standup|2||N|Y||890.3900|1|||||N|N
PM|PM|IPM|Cover, Limb|1||Y|N||890.3025|4|||||N|N
PM|PM|IPO|Orthosis, Pneumatic Structure, Rigid|3||N|N||890.3610|2|Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96||||N|N
PM|PM|IPR|Crutch|1||Y|N||890.3150|4|||||N|N
PM|PM|IPS|Cane|1||Y|N||890.3075|4|||||N|N
PM|PM|IPT|Orthosis, Thoracic|1||Y|N||890.3490|4|||||N|N
PM|PM|IPW|Orthosis, Sacroiliac, Soft|1||Y|N||890.3490|4|||||N|N
PM|PM|IPX|Orthosis, Rib Fracture, Soft|1||Y|N||890.3490|4|||||N|N
PM|PM|IPY|Orthosis, Lumbo-Sacral|1||Y|N||890.3490|4|||||N|N
PM|PM|IQA|System, Environmental Control, Powered|2||N|N||890.3725|4|||||N|N
PM|PM|IQB|Belt, Wheelchair|1||N|N||890.3920|4|||||N|N
PM|PM|IQC|Wheelchair, Special Grade|2||N|Y||890.3880|1|||||N|N
PM|PM|IQE|Orthosis, Lumbar|1||Y|N||890.3490|4|||||N|N
PM|PM|IQF|Orthosis, Cervical-Thoracic, Rigid|1||Y|N||890.3490|4|||||N|N
PM|PM|IQG|Adaptor, Holder, Syringe|1||Y|N||890.5050|4|||||N|N
PM|PM|IQI|Orthosis, Limb Brace|1||Y|N||890.3475|4|||||N|N
PM|PM|IQJ|Splint, Clavicle|1||Y|N||890.3490|4|||||N|N
PM|PM|IQK|Orthosis, Cervical|1||Y|N||890.3490|4|||||N|N
PM|PM|IQM|Splint, Temporary Training|1||Y|N||890.3025|4|||||N|N
PM|PM|IQO|Device, Prosthesis Alignment|1||Y|N||890.3025|4|||||N|N
PM|PM|IQP|Rotator, Transverse|1||Y|N||890.3025|4|||||N|N
PM|PM|IQQ|Joint, Shoulder, External Limb Component|1||Y|N||890.3420|4|||||N|N
PM|PM|IQW|Hook, External Limb Component, Powered|1||Y|N||890.3420|4|||||N|N
PM|PM|IQX|Hook, External Limb Component, Mechanical|1||Y|N||890.3420|4|||||N|N
PM|PM|IQZ|Hand, External Limb Component, Powered|1||Y|N||890.3420|4|||||N|N
PM|PM|IRA|Hand, External Limb Component, Mechanical|1||Y|N||890.3420|4|||||N|N
PM|PM|IRD|Joint, Elbow, External Limb Component, Mechanical|1||Y|N||890.3420|4|||||N|N
PM|PM|IRE|Joint, Elbow, External Limb Component, Powered|1||Y|N||890.3420|4|||||N|N
PM|PM|IRN|Device, Warning, Overload, External Limb, Powered|2||N|P||890.5575|4|||||N|N
PM|PM|IRO|Vibrator, Therapeutic|1||N|N||890.5975|4|||||N|N
PM|PM|IRP|Massager, Powered Inflatable Tube|2||N|P||890.5650|1|||||N|N
PM|PM|IRQ|Unit, Heating, Powered|1||N|N||890.5950|4|||||N|N
PM|PM|IRR|Bars, Parallel, Powered|1||N|N||890.5380|4|||||N|N
PM|PM|IRS|Head Halter, Traction|1||Y|N||890.5925|4|||||N|N
PM|PM|IRT|Pad, Heating, Powered|2||N|N||890.5740|4|||||N|N
PM|PM|ISA|Massager, Therapeutic, Electric|1||N|N||890.5660|4|||||N|N
PM|PM|ISB|Stimulator, Muscle, Diagnostic|2||N|P||890.1850|1|||||N|N
PM|PM|ISD|Exerciser, Measuring|2||N|P||890.5360|4|||||N|N
PM|PM|ISH|Component, External, Limb, Ankle/Foot|1||Y|N||890.3420|4|||||N|N
PM|PM|ISL|Joint, Hip, External Limb Component|1||Y|N||890.3420|4|||||N|N
PM|PM|ISM|Pylon, Post Surgical|1||Y|N||890.3025|4|||||N|N
PM|PM|ISN|Cable|1||Y|N||890.3420|4|||||N|N
PM|PM|ISP|Valve, Prosthesis|1||Y|N||890.3420|4|||||N|N
PM|PM|ISR|Band Or Belt, Pelvic Support|1||Y|N||890.3025|4|||||N|N
PM|PM|ISS|Prosthesis, Thigh Socket, External Component|1||Y|N||890.3420|4|||||N|N
PM|PM|ISW|Assembly, Knee/Shank/Ankle/Foot, External|2||N|N||890.3500|4|||||N|N
PM|PM|ISY|Joint, Knee, External Limb Component|1||Y|N||890.3420|4|||||N|N
PM|PM|ISZ|Unit, Wrist, External Limb Component, Mechanical|1||Y|N||890.3420|4|||||N|N
PM|PM|ITC|Stirrup, External Brace Component|1||Y|N||890.3410|4|||||N|N
PM|PM|ITG|Bandage, Cast|1||Y|N||890.3025|4|||||N|N
PM|PM|ITH|Equipment, Traction, Powered|2||N|P||890.5900|1|||||N|N
PM|PM|ITI|Wheelchair, Powered|2||N|Y||890.3860|1|||||N|N
PM|PM|ITJ|Walker, Mechanical|1||Y|N||890.3825|4|||||N|N
PM|PM|ITM|Cage, Knee|1||Y|N||890.3475|4|||||N|N
PM|PM|ITN|Splint, Denis Brown|1||Y|N||890.3675|4|||||N|N
PM|PM|ITO|Twister, Brace Setting|1||Y|N||890.3410|4|||||N|N
PM|PM|ITQ|Joint, Knee, External Brace|1||Y|N||890.3475|4|||||N|N
PM|PM|ITS|Joint, Hip, External Brace|1||Y|N||890.3475|4|||||N|N
PM|PM|ITW|Joint, Ankle, External Brace|1||Y|N||890.3475|4|||||N|N
PM|PM|JFA|Exerciser, Finger, Powered|1||N|N||890.5410|4|||||N|N
PM|PM|JFB|Table, Physical Therapy, Multi Function|2||N|P||890.5880|1|||||N|N
PM|PM|JFC|System, Pressure Measurement, Intermittent|1||N|N||890.1600|4|||||N|N
PM|PM|KFX|Assembly, Thigh/Knee/Shank/Ankle/Foot, External|2||N|N||890.3500|4|||||N|N
PM|PM|KGH|Unit, Wrist, External Limb Component, Powered|1||Y|N||890.3420|4|||||N|N
PM|PM|KHX|Platform, Force-Measuring|1||N|N||890.1575|4|||||N|N
PM|PM|KHY|Cane, Safety Walk|1||Y|N||890.3075|4|||||N|N
PM|PM|KIC|Cushion, Flotation|1||N|N||890.3175|4|||||N|N
PM|PM|KID|Restraint, Wheelchair, Non-Protective|1||Y|N||890.3910|4|||||N|N
PM|PM|KNL|Board, Scooter, Prone|1||Y|N||890.5370|4|||||N|N
PM|PM|KNM|Device, Pressure Applying|1||N|N||890.5765|4|||||N|N
PM|PM|KNN|Components, Wheelchair|1||N|N||890.3920|4|||||N|N
PM|PM|KNO|Accessories, Wheelchair|1||Y|N||890.3910|4|||||N|N
PM|PM|KNP|Orthosis, Corrective Shoe|1||Y|N||890.3475|4|||||N|N
PM|PM|KTB|Device, Iontophoresis, Specific Uses|2||N|P||890.5525|1|||||N|N
PM|PM|KTC|Bath, Sitz, Nonpowered|1||Y|N||890.5125|4|||||N|N
PM|PM|KTD|Orthosis, Abdominal|1||Y|N||890.3490|4|||||N|N
PM|PM|LBE|Stroller, Adaptive|1||N|Y|M|890.3850|1|||||N|N
PM|PM|LXF|Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat|3||N|N||890.5300|2|||||N|N
PM|PM|LYG|Massager, Therapeutic, Manual|1||N|N||890.5660|4|||||N|N
PM|PM|MPO|Infant Heel Warmer (Chemical Heat Pack)|1||N|Y||890.5710|1|||||N|N
PM|PM|MRI|Orthosis, Truncal/Orthosis, Limb|1||Y|N||890.3490|4|||||N|N
PM|PM|NDA|Helmet, Cranial, For Protective Use|1||Y|N||890.3025|4|||||N|N
PM|PM|NGX|Stimulator, Muscle, Powered, For Muscle Conditioning|2||N|N||890.5850|1|A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance.  Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.||||N|N
PM|PM|NHF|Monitor, Orthotic/Prosthetic|1||Y|N||890.3025|4|A monitor, orthotic/prosthetic is a non-invasive, battery-powered, data storage accessory device that is attached to or embedded in medical appliances such as splints, braces, orthotics, prosthetics, and wearable exercise devices, to record how often the appliance is worn, through the use of sensors that record changes in temperature, motion, skin proximity, etc.||||N|N
PM|PM|NHN|Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy|2||N|N||890.5500|1|A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. This device emits energy in the infrared or other wavelengths, provides non-heating and non-thermal effect, and is indicated for adjunctive use in pain therapy or related indication.  It does not provide therapeutic topical heating. The classification regulation for infrared lamps describes a device that emits energy in the infrared wavelength to provide topical heating and that is not limited to adjunctive use.||||N|N
PM|PM|NJB|Orthosis, Truncal, For Dysmenorrhea|1||Y|N||890.3490|4|A truncal orthosis for dysmenorrhea is a device intended to provide pressure to acupressure points on the lower abdomen and lower back for the purpose of reducing menstrual pain symptoms including cramps, abdominal pain and backache.||||N|N
PM|PM|NXB|Dispenser, Solid Medication|1||Y|N||890.5050|4|A solid medication dispenser is a device intended for medical purposes that is used to issue solid (pills) medication.|The device is designed for primarily oral dosage forms of medication.|This device can function independently, with components or within a system.|dependent on drug indication.|N|N
PM|PM|NXE|Walker, Mechanical, Poly Vinyl Chloride (Pvc)|1||Y|N||890.3825|4|This type of mechanical walker is a four-legged device with a poly vinyl chloride (pvc) frame intended for medical purposes to provide moderate weight support while walking.  It is used by disabled persons who lack strength, good balance, or endurance.|PVC|Class 1 (General Controls)|limbs|N|N
PM|PM|NYY|Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation|2||N|N||890.5850|1|Used for muscle stimulation for rehabilitation.  Device repeatedly contracts muscles by passing pulsed electrical current through cutaneous electrodes contacting the affected body area.  Indicated for use as an adjunctive therapy in rehabilitation for medical purposes such as relaxation of muscle spasm, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.|Electrical stimulation unit with leads and cutaneous electrodes|Stimulation of muscles using electrical current applied to electrodes on a patient's skin|Electrodes are placed on the skin overlying the muscle or motor nerve to be stimulated|N|N
PM|PM|NYZ|Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning|2||N|N||890.5850|1|Used for muscle stimulation for muscle conditioning.  Device repeatedly contracts muscles by passing pulsed electrical current through cutaneous electrodes and into the body. Temporarily affects the stimulated muscles contractile properties, force output, and/or fatigue resistance.  Not intended to be used for medical purposes (e.g., rehabilitation), for aesthetic purposes (e.g., changing the physical appearance of the muscle or body), or for the purpose of improving athletic performance.|Electrical stimulation unit with leads and cutaneous electrodes|Stimulation of muscles using electrical current applied to electrodes on a patient's skin|Electrodes are placed on the skin overlying the muscle or motor nerve to be stimulated|N|N
PM|PM|OAL|Exercise Equipment, Powered, Emg-Triggered|2||N|N||890.1375|1|To provide rehabilitation (e.G., increasing range of motion, muscle re-education) through emg-triggered powered exercise. Increasing range of motion and muscle re-education.|EMG sensor, plus other apparatus such as a DC motor, limb orthosis, and connecting cables through which tension is applied.|EMG in affected area is sensed, processed, and used as an input to control a DC motor or other actuator that applies a force/torque to move an affected joint through range of motion.|Typically, such a device will be used on the upper extremity or possibily the lower extremity.|N|N
PM|PM|OHI|Orthosis, Foot Drop|1||Y|N||890.3475|4|Aid for drop foot or similar disorders which have a lack of ankle dorsiflexion.  Indicated for foot raising paresis.|includes shoulder harness, optional waist belt, optional shoulder pad, an elastic cord assembly and a shoe harness|uses an elastic cord from shoulder harness to foot to provide foot raising support|intended to help raise foot|N|N
PM|PM|OJL|Insulin Vial Protector/Holder|1||N|N||890.5050|4|The device is intended to protect an insulin vial or vials|The device is made of a variety of durable plastics and fabrics. All devices consist of an inner core that surrounds the vial for protection.|The device functions independently providing a protective barrier to shield and protect the insulin vial.|The device is intended to protect the insulin vial.  The device itself does not act on the body at all.|N|N
PM|PM|OMW|Adhesive Backed Thermal Skin Patches|1||N|N||890.5710|4|Pain relief heat patches for temporary relief of muscular and joint pian assoiciated with arthritis, simple backache, muscle strains and sprains.External use only. Not on damaged skin or open sores.  Do no use under the age of 12.  Do use on people who are not able to feel pain.  Patch is applied directly to site of pain over intact skin for up to 8 hours but not more than once in a 24 hour period.  Do not use more than 7 days. Over the counter device. No prescription. Do not sleep on or put pressure on heat patch for extended period of time. Do not use with any creams or oils. Can remove body hair upon patch removal due to adhesive.  Can cause burns.|MFR must identify if  there are any iron or metal components or filings to avoid incompatibility with MRI.  See March 2009 CDER advisory on metal backed patches and MRI.  Not for face or head.|Heat patches provide portable heat, are non-medicated. Heat is air-activated.  Provides up to 8 hours of continous warmth. Patches are designed to stay in place all day.|Use over site of pain on any external body part with the exception of face or head.|N|N
PM|PM|ONH|Powered Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy|2||N|N||890.5500|1|A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. This device emits energy in the infrared or other wavelengths, provides non-heating and non-thermal effect, and is indicated for adjunctive use in pain therapy or related indication.  It does not provide therapeutic topical heating. The classification regulation for infrared lamps describes a device that emits energy in the infrared wavelength to provide topical heating and that is not limited to adjunctive use.|The device comes in a verity of shapes and sizes. It could be hand held and with weight less than one pound or it could be heavier. It may have a base station with attachments such as different hand piece(s) and touch tone/display screen or other mechanical buttons for user interactions.|A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. This device emits energy in the infrared or other wavelengths, provides non-heating and non-thermal effect.|Generally targets body area, over intact skin, known to be associated causing physical pain such as joints and back.|N|N
PM|PM|OSD|Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature|2||N|N||890.5670|4|Rectal or vaginal use manual therapeutic massager device to massage irritable, sore trigger points (trps) in the pelvic floor musculature in order to reduce internal pelvic floor trigger point sensitivity|An extended shaft witha hook-shaped end and a handle and a gauge that measures pressure of massage|Manual massage|Pelvic floor musculature|N|N
PM|PM|OZC|Over The Counter Thermal Treatment For Acne.|2||N|N||890.5740|1|For the treatment of mild to moderate inflammatory acne.|In addition to the device, there may be batteries, re-charger, USB cable|Deliver heat to acne to kill propionibacterium acne virus|Acne/pimples|N|N
PM|PM|PAE|Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography|2||N|N||890.3450|1|Upper extremity prosthesis intended to replace partially or fully amputated or congenitally absent upper extremities and to provide multiple and simultaneous degrees of freedom and functionality.|Upper extremity prosthesis composed of plastic and metal materials with electrodes and circuitry.|Receives multiple EMG inputs from the user which is transduced into multiple dimensional powered joint movements.|Residual portion of upper extremity limb or an absent upper extremity limb.|N|N
PM|PM|PCD|Powered Stairway Chair Lift|2||N|N||890.5150|4|Intended for medical purposes to move a person with impaired mobility up and down a stairway.|A motorized lift equipped with a seat and permanently mounted in one location on a stairway|A powered patient stairway chair lift is a motorized lift equipped with a seat and permanently mounted in one location that is intended for medical purposes to move a person with impaired mobility up and down a stairway.|n/a|N|N
PM|PM|PCE|Permanently Mounted Wheelchair Platform Lift|2||N|N||890.3930|4|Intended for medical purposes to provide a guided platform to move a person with impaired mobility, with or without a wheelchair, from one level to another.|A permanently mounted wheelchair platform lift is a motorized vertical or inclined platform lift device permanently installed in one location.|A permanently mounted guided platform to move a person with impaired mobility, with or without a wheelchair, from one level to another.|n/a|N|N
PM|PM|PFW|Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat|2||N|N||890.5300|1|Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.|Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.|The device uses ultrasonic energy to produce deep heat within the body.|To be applied over body areas such as the shoulder and knee; however, the device should not be applied directly over bone that is near the skin surface.|N|N
PM|PM|PHW|Cold Pack And Vibrating Massager|1||N|N||890.5975|4|Relief of minor aches and pains, controlling the pain associated with needle sticks (injections, IV, venipuncture).|Cold pack with vibrating massager|Combines a cold pack with therapeutic massage to provide vibrating cold therapy|Applied to the skin on various parts of the body|N|N
PM|PM|PKS|Exerciser, Non-Measuring For Stroke Rehabilitation|1||N|N||890.5370|4|Non-measuring exercise equipment intended for medical purposes of facilitating stroke rehabilitation and maintaining or increasing range of motion.|The device may consist of two arm frames mechanically linked that allow the user to use the unaffected arm to move the affect/weak arm.  The device may also consist of a single frame that is used by both upper extremities simultaneously with the unaffected upper extremity facilitating movement of the affected upper extremity.|These devices are not powered exercise devices in that they do not provide movement to the user¿s upper limbs.  The movement of the user's upper limbs is entirely governed by the user.|Upper extremities|N|N
PM||HTM|Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive|3||N|N|||2|||||N|N
PM||KFT|Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical|U|1|N|N|||1|||||N|N
PM||KFW|Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Powered|U|1|N|N|||1|||||N|N
PM||KHZ|Control, Foot Driving, Automobile, Mechanical[Regulated By Dept. Of Transportation]|N|7|N|N|||3|||||N|N
PM||LBG|Device, Fluidized Therapy, Dry Heat|U|1|N|N|||1|||||N|N
PM||LDK|Device, Sensing, Optical Contour|U|1|N|N|||1|||||N|N
PM||LFF|Unit, Activation, Breath Control|U|1|N|N|||1|||||N|N
PM||LOE|Stimulator, Invasive Bone Growth|3||N|N|||2|||||N|N
PM||LOF|Stimulator, Bone Growth, Non-Invasive|3||N|N|||2|||||N|N
PM||LPQ|Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep|3||N|N|||2|||||N|N
PM||LSB|Unit, Fluidotherapy|U|1|N|N|||1|||||N|N
PM||LWB|Stimulator, Functional Neuromuscular, Scoliosis|3||N|N|||2|||||N|N
PM||LXJ|System, Optical Position/Movement Recording|U|1|N|N|||1|||||N|N
PM||LXM|Manipulator, Plunger-Like Joint|U|1|N|N|||1|||||N|N
PM||LZW|Monitor, Spine Curvature|U|1|N|N|||4|||||N|N
PM||MBQ|Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing|3||N|N|||3|||||N|N
PM||MBS|Filler, Bone Void, Non-Osteoinduction|3||N|N|||2|||||N|N
PM||MLQ|Inhibitor, Peridural Fibrosis (Adhesion Barrier)|3||N|N|||2|||||N|N
PM||MLX|Pad, Medicated, Adhesive, Non-Electric|U|1|N|N|||1|||||N|N
PM||MLY|Refrigerant, Topical (Vapocoolant)|U|1|N|N|||1|||||N|N
PM||MNE|Orthosis, Moldable, Supportive, Skin Protective|U|1|N|N|||1|||||N|N
PM||MOC|Cushion, Flotation, Therapeutic|U|1|N|N|||1|||||N|N
PM||MPW|Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction|3||N|N|||2|Pma approved:  P000054||||N|N
PM||NHH|Device, Discharge, Electrostatic (For Pain Relief)|U|1|N|N|||1|An electrostatic discharge device which applies an electrostatic or coronal discharge to or near a person's skin for the symptomatic relief of pain||||N|N
PM||NZF|Static Electricity-Emitting Device, Cosmetic Use|N|6|N|N|||7|Intended for relaxation and cosmetic use.|Hand held bulb and the bulb creates static electricity that is applied to the skin.|Application of static electricity to skin.|Skin|N|N
PM||OYR|Filler, Bone Void, Recombinant Platelet-Derived Growth Factor|N|3|N|N|||3|For use as an alternative to autograft in hindfoot and ankle fusion procedures that require supplemental graft material, including tibiotalar, tibiocalcaneal, talonavicular and calcaneocuboid fusions.|The product consists of 1.5, 3, 6, or 9 cc of beta-tricalcium phosphate in granule form and 1.5, 3, 6, or 9 ml of rhPDGF-BB (0.3 mg/ml) in liquid form.  The two components are mixed in equal volumes prior to use.|The platelet-derived growth factor component is intended to function as a chemo-attractant and mitogen for cells that stimulate the repair and growth of new bone.  The osteoconductive calcium phosphate component is intended to act as a scaffold for new bone growth.|The product is utilized in the hindfoot and ankle for fusion procedures that include tibiotalar, tibiocalcaneal, talonavicular and calcaneocuboid fusions.|Y|Y
PM||OZJ|Inhibitor, Postoperative Fibrosis (Adhesion Barrier)|N|3|N|N|||3|The device is designed to coat surfaces exposed in tendon and peripheral nerve surgery, in order to form a temporary mechanical barrier that separates tissues for the purpose of reducing fibrosis and reducing the formation of adhesions.|The gel is a sterile, absorbable, isotonic combination of sodium carboxymethylcellulose (CMC) and polyethylene oxide (PEO) with calcium chloride and sodium chloride in sterile water for injection.|The product is applied to coat the surgically traumatized tissue and surrounding area.  The gel remains at the site of application for a period of time, providing a barrier to adhesion formation during the healing process.  The material is absorbed.  It does not require a second operation for removal.|The product is designed to coat surfaces exposed in tendon and peripheral nerve surgery, in order to form a temporary mechanical barrier that separates tissues.|N|N
PM||PCQ|Inhibitor, Postoperative Fibrosis (Spine Adhesion Barrier)|N|3|N|N|||3|Intended for use as a mechanical barrier to adhesion formation.|The gel is a sterile, absorbable, isotonic combination of sodium carboxymethylcellulose (CMC) and polyethylene oxide (PEO) with calcium chloride and sodium chloride in sterile water for injection.  A syringe and applicator are provided to deliver the gel.|The product is applied to coat the surgically traumatized tissue and surrounding area.  The gel remains at the site of application for a period of time, providing a barrier to adhesion formation during the healing process.  The material is absorbed.  It does not require a second operation for removal.|Neural tissues in the spine.|N|N
RA|DE|EAG|Cephalometer|2||N|P||872.1830|1|||||N|N
RA|DE|EAH|Cone, Radiographic, Lead-Lined|1||N|N||872.1850|4|||||N|N
RA|DE|EAP|Unit, X-Ray, Intraoral|2||N|Y||872.1810|1|||||N|N
RA|DE|EHB|Collimator, X-Ray|1||N|N||872.1840|4|||||N|N
RA|DE|EHD|Unit, X-Ray, Extraoral With Timer|2||N|Y||872.1800|1|||||N|N
RA|DE|MUH|System,X-Ray,Extraoral Source,Digital|2||N|Y||872.1800|1|||||N|N
RA|GU|FCD|Kit, Barium Enema, Disposable|1||N|N||876.5210|4|||||N|N
RA|OB|IYM|System, Telethermographic, Infrared|3||N|N||884.2980|2|||||N|N
RA|OB|KXZ|System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)|3||N|N||884.2982|2|||||N|N
RA|OB|KYA|System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)|1||N|Y|M|884.2982|4|||||N|N
RA|OB|LHM|System, Thermographic, Liquid Crystal|1||N|Y|M|884.2982|4|||||N|N
RA|OB|LHP|System, Telethermographic (Sole Diagnostic Screen)|3||N|N||884.2980|2|||||N|N
RA|OB|LHQ|System, Telethermographic (Adjunctive Use)|1||N|Y|M|884.2980|1|||||N|N
RA|OB|LHR|System, Thermographic, Liquid Crystal (Sole Diagonistic Screen)|3||N|N||884.2982|2|||||N|N
RA|OB|LXE|Doppler, Fetal, Ultrasound|2||N|Y|M|884.2660|1|||||N|N
RA|OB|MAA|Monitor, Fetal Doppler Ultrasound|2||N|Y|M|884.2660|1|||||N|N
RA|RA|EAJ|Apron, Leaded|1||N|N||892.6500|4|||||N|N
RA|RA|EAK|Screen, Leaded, Operator Radiation Protector|1||N|N||892.6500|4|||||N|N
RA|RA|EAM|Screen, Intensifying, Radiographic|1||N|N||892.1960|4|||||N|N
RA|RA|EGT|Controller, Temperature, Radiographic|2||N|Y|M|892.1900|7|||||N|N
RA|RA|EGW|Dryer, Film, Radiographic|2||N|Y|M|892.1900|7|||||N|N
RA|RA|EGY|Processor, Radiographic-Film, Automatic, Dental|2||N|Y|M|892.1900|7|||||N|N
RA|RA|HBK|Chair, Pneumoencephalographic|2||N|Y|M|892.1820|7|||||N|N
RA|RA|ITX|Transducer, Ultrasonic, Diagnostic|2||N|Y|M|892.1570|1|||||N|N
RA|RA|ITY|Assembly, Tube Housing, X-Ray, Diagnostic|1||N|N||892.1760|4|||||N|N
RA|RA|ITZ|Assembly, Tube Housing, X-Ray, Therapeutic|2||N|Y||892.5930|1|||||N|N
RA|RA|IWA|Source, Wire, Iridium, Radioactive|2||N|P||892.5730|1|||||N|N
RA|RA|IWB|System, Radiation Therapy, Radionuclide|2||N|P||892.5750|1|||||N|N
RA|RA|IWD|Device, Beam Limiting, Teletherapy, Radionuclide|2||N|P||892.5750|1|||||N|N
RA|RA|IWE|Monitor, Patient Position, Light-Beam|1||N|N||892.5780|4|||||N|N
RA|RA|IWF|Needle, Isotope, Gold, Titanium, Platinum|2||N|P||892.5730|1|||||N|N
RA|RA|IWG|Seed, Isotope, Gold, Titanium, Platinum|2||N|N||892.5730|1|||||Y|N
RA|RA|IWH|Source, Teletherapy, Radionuclide|1||N|N||892.5740|4|||||N|N
RA|RA|IWI|Source, Isotope, Sealed, Gold, Titanium, Platinum|2||N|P||892.5730|1|||||N|N
RA|RA|IWJ|System, Applicator, Radionuclide, Manual|1||N|N||892.5650|4|||||N|N
RA|RA|IWK|Cyclotron, Medical|2||N|P||892.5050|1|||||N|N
RA|RA|IWL|System, Radiation Therapy, Neutron, Medical|2||N|P||892.5300|1|||||N|N
RA|RA|IWM|Synchrotron, Medical|2||N|P||892.5050|1|||||N|N
RA|RA|IWN|Cassette, Measurement, Ardran-Crooks|1||Y|N||892.1940|4|||||N|N
RA|RA|IWO|Apron, Protective|1||N|N||892.6500|4|||||N|N
RA|RA|IWP|Radiographic Protective Glove|1||N|N||892.6500|4|A protective radiographic glove is a "personnel protective shield."  The gloves are intended to protect the operator, patient, or other person from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier to radiation. Note:  These devices are not patient examination gloves or surgeon's gloves.  -||||N|N
RA|RA|IWQ|Curtain, Protective, Radiographic|1||N|N||892.6500|4|||||N|N
RA|RA|IWR|Holder, Syringe, Lead|1||N|N||892.6500|4|||||N|N
RA|RA|IWS|Shield, Eye, Radiological|1||N|N||892.6500|4|||||N|N
RA|RA|IWT|Shield, Gonadal|1||N|N||892.6500|4|||||N|N
RA|RA|IWW|Shield, Vial|1||N|N||892.6500|4|||||N|N
RA|RA|IWX|Barrier, Control Panel, X-Ray, Movable|1||N|N||892.6500|4|||||N|N
RA|RA|IWY|Holder, Head, Radiographic|1||Y|N||892.1920|4|||||N|N
RA|RA|IWZ|Film, Radiographic|1||N|N||892.1840|4|||||N|N
RA|RA|IXA|Cassette, Radiographic Film|2||N|Y|M|892.1850|7|||||N|N
RA|RA|IXC|Illuminator, Radiographic-Film|1||N|N||892.1890|4|||||N|N
RA|RA|IXD|Source, Calibration, Sealed, Nuclear|1||N|N||892.1400|4|||||N|N
RA|RA|IXF|Test-Pattern, Radiographic|1||Y|N||892.1940|4|||||N|N
RA|RA|IXG|Phantom, Anthropomorphic, Radiographic|1||Y|N||892.1950|4|||||N|N
RA|RA|IXH|Camera, Focal Spot, Radiographic|1||Y|N||892.1940|4|||||N|N
RA|RA|IXI|Block, Beam-Shaping, Radiation Therapy|2||N|P||892.5710|1|||||N|N
RA|RA|IXJ|Grid, Radiographic|1||N|N||892.1910|4|||||N|N
RA|RA|IXK|System, Imaging, X-Ray, Electrostatic|2||N|Y|M|892.1630|1|||||N|N
RA|RA|IXL|Device, Spot-Film|2||N|Y|M|892.1670|7|||||N|N
RA|RA|IXO|Synchronizer, Ecg/Respirator, Radiographic|1||N|N||892.1970|4|||||N|N
RA|RA|IXQ|Table, Radiographic, Stationary Top|2||N|N||892.1980|4|||||N|N
RA|RA|IXR|Table, Radiographic, Tilting|2||N|N||892.1980|4|||||N|N
RA|RA|IXW|Processor, Radiographic-Film, Automatic|2||N|Y|M|892.1900|7|||||N|N
RA|RA|IXX|Processor, Cine Film|2||N|P|M|892.1900|7|||||N|N
RA|RA|IXY|Holder, Radiographic Cassette, Wall-Mounted|1||N|N||892.1880|4|||||N|N
RA|RA|IYB|Tube Mount, X-Ray, Diagnostic|1||N|N||892.1770|4|||||N|N
RA|RA|IYC|Generator, Orthovoltage, Therapeutic X-Ray|2||N|P||892.5900|1|||||N|N
RA|RA|IYD|Generator, Low Voltage, Therapeutic X-Ray|2||N|P||892.5900|1|||||N|N
RA|RA|IYE|Accelerator, Linear, Medical|2||N|P||892.5050|1|||||N|N
RA|RA|IYG|Betatron, Medical|2||N|P||892.5050|1|||||N|N
RA|RA|IYH|Generator, Dermatological (Grenz Ray), Therapeutic X-Ray|2||N|P||892.5900|1|||||N|N
RA|RA|IYI|Collimator, Orthovoltage, Therapeutic X-Ray|2||N|P||892.5900|1|||||N|N
RA|RA|IYJ|Collimator, Low Voltage, Therapeutic X-Ray|2||N|P||892.5900|1|||||N|N
RA|RA|IYK|Collimator, High Voltage, Therapeutic X-Ray|2||N|P||892.5900|1|||||N|N
RA|RA|IYL|Collimator, Dermatological, Therapeutic X-Ray|2||N|P||892.5900|1|||||N|N
RA|RA|IYN|System, Imaging, Pulsed Doppler, Ultrasonic|2||N|Y|M|892.1550|1|||||N|N
RA|RA|IYO|System, Imaging, Pulsed Echo, Ultrasonic|2||N|Y|M|892.1560|1|||||N|N
RA|RA|IYP|Phantom, Anthropomorphic, Nuclear|1||N|N||892.1370|4|||||N|N
RA|RA|IYQ|Phantom, Flood Source, Nuclear|1||N|N||892.1380|4|||||N|N
RA|RA|IYT|System, Rebreathing, Radionuclide|2||N|P||892.1390|1|||||N|N
RA|RA|IYW|Scanner, Rectilinear, Nuclear|1||N|N||892.1300|4|||||N|N
RA|RA|IYX|Camera, Scintillation (Gamma)|1||N|Y|M|892.1100|1|||||N|N
RA|RA|IYY|Synchronizer, Electrocardiograph, Nuclear|1||N|N||892.1410|4|||||N|N
RA|RA|IYZ|Bed, Scanning, Nuclear|1||N|N||892.1350|4|||||N|N
RA|RA|IZC|Camera, Positron|1||N|Y|M|892.1110|1|||||N|N
RA|RA|IZD|Probe, Uptake, Nuclear|1||N|N||892.1320|4|||||N|N
RA|RA|IZF|System, X-Ray, Tomographic|2||N|Y|M|892.1740|1|||||N|N
RA|RA|IZG|System, X-Ray, Photofluorographic|2||N|P||892.1730|1|||||N|N
RA|RA|IZH|System, X-Ray, Mammographic|2||N|Y||892.1710|1|||||N|N
RA|RA|IZI|System, X-Ray, Angiographic|2||N|Y|M|892.1600|1|||||N|N
RA|RA|IZJ|Camera, X-Ray, Fluorographic, Cine Or Spot|2||N|Y|M|892.1620|1|||||N|N
RA|RA|IZL|System, X-Ray, Mobile|2||N|Y|M|892.1720|1|||||N|N
RA|RA|IZO|Generator, High-Voltage, X-Ray, Diagnostic|1||N|N||892.1700|4|||||N|N
RA|RA|IZP|Programmer, Changer, Film/Cassette, Radiographic|2||N|Y|M|892.1870|7|||||N|N
RA|RA|IZS|Aperture, Radiographic|2||N|Y|M|892.1610|7|||||N|N
RA|RA|IZT|Cone, Radiographic|2||N|Y|M|892.1610|7|||||N|N
RA|RA|IZW|Collimator, Automatic, Radiographic|2||N|Y|M|892.1610|7|||||N|N
RA|RA|IZX|Collimator, Manual, Radiographic|2||N|Y|M|892.1610|7|||||N|N
RA|RA|IZZ|Table, Radiographic, Non-Tilting, Powered|2||N|N||892.1980|4|||||N|N
RA|RA|JAA|System, X-Ray, Fluoroscopic, Image-Intensified|2||N|Y|M|892.1650|1|||||N|N
RA|RA|JAB|System, X-Ray, Fluoroscopic, Non-Image-Intensified|2||N|P||892.1660|1|||||N|N
RA|RA|JAC|System, X-Ray, Film Marking, Radiographic|1||N|N||892.1640|4|||||N|N
RA|RA|JAD|System, Therapeutic, X-Ray|2||N|P||892.5900|1|||||N|N
RA|RA|JAE|Microtron, Medical|2||N|P||892.5050|1|||||N|N
RA|RA|JAF|Monitor, Ultrasonic, Nonfetal|2||N|Y|M|892.1540|1|||||N|N
RA|RA|JAG|Illuminator, Radiographic-Film, Explosion-Proof|1||N|N||892.1890|4|||||N|N
RA|RA|JAI|Couch, Radiation Therapy, Powered|2||N|P||892.5770|1|||||N|N
RA|RA|JAK|System, X-Ray, Tomography, Computed|2||N|Y|M|892.1750|1|||||N|N
RA|RA|JAM|Scanner, Whole Body, Nuclear|1||N|N||892.1330|4|||||N|N
RA|RA|JAN|Counter, Whole Body, Nuclear|1||N|N||892.1130|4|||||N|N
RA|RA|JAO|Scanner, Fluorescent|2||N|P||892.1220|1|||||N|N
RA|RA|JAQ|System, Applicator, Radionuclide, Remote-Controlled|2||N|P||892.5700|1|||||N|N
RA|RA|JAR|Phantom, Test-Pattern, Radionuclide|1||N|N||892.1420|4|||||N|N
RA|RA|JWM|System, Tomographic, Nuclear|2||N|Y|M|892.1310|1|||||N|N
RA|RA|KGI|Densitometer, Bone|2||N|P||892.1170|1|||||N|N
RA|RA|KPQ|System, Simulation, Radiation Therapy|2||N|P||892.5840|1|||||N|N
RA|RA|KPR|System, X-Ray, Stationary|2||N|Y|M|892.1680|1|||||N|N
RA|RA|KPS|System, Tomography, Computed, Emission|2||N|Y|M|892.1200|1|||||N|N
RA|RA|KPT|Calibrator, Dose, Radionuclide|2||N|Y|M|892.1360|1|||||N|N
RA|RA|KPW|Device, Beam Limiting, X-Ray, Diagnostic|2||N|P|M|892.1610|7|||||N|N
RA|RA|KPX|Changer, Radiographic Film/Cassette|2||N|P|M|892.1860|7|||||N|N
RA|RA|KPY|Shield, Protective, Personnel|1||N|N||892.6500|4|||||N|N
RA|RA|KPZ|Generator, High Voltage, X-Ray, Therapeutic|2||N|P||892.5900|1|||||N|N
RA|RA|KQA|Device, Beam Limiting, X-Ray, Therapeutic|2||N|P||892.5900|1|||||N|N
RA|RA|KXH|Cradle, Patient, Radiologic|1||N|N||892.1830|4|||||N|N
RA|RA|KXJ|Table, Radiologic|2||N|N||892.1980|4|||||N|N
RA|RA|KXK|Source, Brachytherapy, Radionuclide|2||N|N||892.5730|1|||||Y|N
RA|RA|LEK|Transilluminator (Diaphanoscope)|2||N|N||892.1990|1|Classified August 17, 1995:  60 fr 36639: Classification into Class III for the transilluminator (diaphanoscope or lightscanner) for breast evaluation requires manufacturers of transilluminators to submit safety and effectiveness tests for the device.||||N|N
RA|RA|LHN|System, Radiation Therapy, Charged-Particle, Medical|2||N|P||892.5050|1|||||N|N
RA|RA|LHO|Instrument, Quality-Assurance, Radiologic|1||Y|N||892.1940|4|||||N|N
RA|RA|LLZ|System, Image Processing, Radiological|2||N|Y||892.2050|1|||||N|N
RA|RA|LMA|Digitizer, Image, Radiological|2||N|Y||892.2030|4|||||N|N
RA|RA|LMB|Device, Digital Image Storage, Radiological|1||N|N||892.2010|4|||||N|N
RA|RA|LMC|Camera, Multi Format, Radiological|2||N|Y||892.2040|4|||||N|N
RA|RA|LMD|System, Digital Image Communications, Radiological|1||N|N||892.2020|4|||||N|N
RA|RA|LNH|System, Nuclear Magnetic Resonance Imaging|2||N|Y|M|892.1000|1|||||N|N
RA|RA|LNI|System, Nuclear Magnetic Resonance Spectroscopic|2||N|Y|M|892.1000|1|||||N|N
RA|RA|LQA|Media, Reusable Image|1||N|N||892.1840|4|||||N|N
RA|RA|MOS|Coil, Magnetic Resonance, Specialty|2||N|Y|M|892.1000|1|||||N|N
RA|RA|MQB|Solid State X-Ray Imager (Flat Panel/Digital Imager)|2||N|Y||892.1680|1|||||N|N
RA|RA|MUA|Bone Sonometer|2||N|N||892.1180|1|A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting transducer, a receiving transducer, and hardware and software for   reception and processing of the received ultrasonic signal.  Reclassified from class 3 pma to class 2 510(k) 892.1180 [docket no. Fda-2005-n-0346] reclassification of bone sonometers||||N|N
RA|RA|MUE|Full Field Digital,System,X-Ray,Mammographic|2||N|N||892.1715|1|||||N|N
RA|RA|MUI|Media,Coupling,Ultrasound|2||N|Y||892.1570|1|||||N|N
RA|RA|MUJ|System,Planning,Radiation Therapy Treatment|2||N|P||892.5050|1|||||N|N
RA|RA|MWP|Cabinet,X-Ray System|2||N|P||892.1680|1|||||N|N
RA|RA|MWW|Accessory - Film Dosimetry System|2||N|N||892.5050|4|||||N|N
RA|RA|NCS|System, Imaging, Holography, Acoustic|2||N|N||892.1550|1|||||N|N
RA|RA|NMP|Needle, Isotope, Reprocessed|2||N|N||892.5730|1|||||N|N
RA|RA|NWE|Colon Computed Tomography System, Computer Aided Detection|2||N|N||892.2050|1|To assist radiologists in the review of multi-slice computed tomography (msct) exams of the colon and highlight potential polyps that the radiologist should review.|Computer based software|Detection algorithm searches for and identifies potential polyps or other lesions on images of the colon acquired using multi-slice computed tomography (msct).|Colon|N|N
RA|RA|NZT|Dosimeter, Ionizing Radiation, Implanted|2||N|N||892.5050|1|Verify radiation dose to organs from external radiation therapy.|glass encapsulated electronics|Radiation causes change in MOSFET diode that is perportional to dose which can be interigated by external reader.|Radiation therapy target organ|Y|N
RA|RA|OAS|X-Ray, Tomography, Computed, Dental|2||N|N||892.1750|1|Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.|X-ray machine|Uses x-ray scanning to produce computed tomographic images|Mouth and associated stuctures|N|N
RA|RA|OEB|Lung Computed Tomography System, Computer-Aided Detection|2||N|N||892.2050|1|To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review.  A computer aided diagnosis, lung computed tomography system is a class 3 device under product code NRR.|Software device.|Detection algorithm searches for and identifies potential nodules on images of the chest acquired using multi-slice computed tomography (msct).|Lung|N|N
RA|RA|OII|Arthrogram Tray|2||N|N||892.1650|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
RA|RA|OIJ|Biopsy Needle Guide Kit|2||N|N||892.1560|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
RA|RA|OIK|Radiology Dental Tray|2||N|N||892.1650|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
RA|RA|OIL|Discography Kit|2||N|N||892.1730|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
RA|RA|OIM|Magnetic Resonance Imaging Disposable Kit|2||N|N||892.1000|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
RA|RA|OIN|Prostate Seeding Kit|2||N|N||892.5730|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
RA|RA|OIO|Radiographic Contrast Tray|2||N|Y||892.1680|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
RA|RA|OIP|Radiology Diagnostic Kit|2||N|N||892.1680|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
RA|RA|OMJ|Chest X-Ray Computer Aided Detection|2||N|N||892.2050|1|To assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review.|Software device.|Detection algorithm searches for and identifies potential nodules on images of the chest acquired using x-ray.|Chest|N|N
RA|RA|ONL|Conformal Brachytherapy Source|2||N|N||892.5730|1|The intended use of the device is for the treatment of cancer by tempeorary intraoperative or surface irradiation. The device contains radioactive material with activity up to 200 mci and is indicated for treatment of temporary intraoperative, interstitial, intracavitary or surface application to treat selected localized tumors.  This brachytherapy source may be used concurrently with or following treatment with other interventions, such as external beam therapy.  Chordomas, chondrosarcomas, soft tissue sarcomas, skin cancers and other accessible tumors could be commonly treated by the device.|The device consissts of a thin polymeric film which is coated with a thin flexible biocompatible coating.|Radioactive Phosphorus-32 is chemically bonded to a biocompatible epoxy backbone to form a flat flexible planar radioactive brachytherapy source.|This brachytherapy source may be used intraoperatively, interstitially, intrcavitarily, or as a surface applicator to treat selected localized tumors.|N|N
RA|RA|OQQ|Diagnostic Ultrasonic Transducer, Robotic|2||N|N||892.1570|1|Diagnostic ultrasonic imaging or monitoring.|piezoelectric material|Robotic component maintains signal and recovers lost signal.|Unspecified|N|N
RA|RA|OUO|Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance|2||N|N||892.1200|1|Imager that generates both both magnetic resonance (mr)  and positron emission tomography (pet) images and provides registration and fusion of these images.  Pet and mr images can be acquired either simultaneously or sequentially.  Anatomical mr images are used for pet attenuation correction.|The combined imager includes hardware and software for acquisition and reconstruction of both PET and MR images.  Software for image fusion/registration is also included|MRI creates images based on the spatial distribution of hydrogen nuclei; PET creates images based on the biodistribution of a radiopharmaceutical.  Radiation from the MRI is non-ionizing radiofrequency radiation; radiation from the PET radiopharmaceutical is ionizing.|whole body|N|N
RA|RA|OWB|Interventional Fluoroscopic X-Ray System|2||N|N||892.1650|1|Interventional fluoroscopy|Fluoroscopic X-Ray system|Fluoroscopy|Human body|N|N
RA|RA|OXO|Image-Intensified Fluoroscopic X-Ray System, Mobile|2||N|N||892.1650|1|Fluoroscopy of the human body.|Hardware|X-ray transmission through human body|Human Body|N|N
RA|RA|PCS|Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox|2||N|N||892.1001|1|Intended for diagnostic use to present images that reflect the magnetic resonance spectra for the determination of iron in the liver for any indication where an assessment of liver iron concentration is needed.  For non-transfusion-dependent thalassemia (NTDT) patients, is intended as an aid in the assessment of NTDT patients for whom deferasirox therapy is being considered and for monitoring of NTDT patients receiving deferasirox therapy.|Postprocessing  software for the measurement of  liver iron concentration (LIC) from magnetic resonance imaging (MRI) data.|Uses MRI data combined with an empirically-derived calibration curve to determine liver iron concentration (LIC).|liver|N|N
RA|RA|PCT|Prostate Immobilizer Rectal Balloon|2||N|N||892.5720|1|Intended to be used for the temporary positioning of the rectal wall and adjacent structure in the male human anatomies. The purpose is to stabilize the prostate during computed tomography (CT) exam, X-ray, or radiation therapy (RT) treatments. The placement of the balloon requires a physician or a physician-directed healthcare professional, and is performed as a separate procedure apart from the standard CT exam and RT treatment.|plastic balloon|water and air pressure|Rectum|N|N
RA|RA|PDK|Cream For X-Ray Attenuation|2||N|N||892.6510|1|The x-ray attenuating cream is intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a gloved hand, followed by donning a second glove. The X-ray attenuating cream is intended to be used during medical procedures where its necessary for hands to be exposed to radiation to offer some degree of protection from radiation exposure.|X-ray attenuating cream|The device consists of a non-toxic, non-heavy metal, radiation absorbing material in a formulated base. Radiation is blocked by the device via absorption of the photon energy from ionizing radiation. This photon energy is dissipated as phonon energy within the atomic lattice structure of the radiation absorbing material.|Healthcare Professional's hands|N|N
RA|RA|PGY|Display, Diagnostic Radiology|2||N|N||892.2050|1|The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.|Hardware and embedded software|Hardware and embedded sofware for displaying radiological images.|Whole body|N|N
RA||IYR|Generator, Radionuclide|U|1|N|N|||1|||||N|N
RA||KTA|Medium, Contrast, Radiologic|U|1|N|N|||1|||||N|N
RA||LLY|System, Radionuclide Infusion|U|1|N|N|||1|||||N|N
RA||LMZ|Applicator, Hyperthermia, Interstitial|3||N|N|||2|||||N|N
RA||LNB|Applicator, Hyperthermia, Deep Heating, Ultrasound|3||N|N|||2|||||N|N
RA||LNC|Applicator, Hyperthermia, Superficial, Rf/Microwave|3||N|N|||2|||||N|N
RA||LOC|System, Rf/Microwave Hyperthermia, Cancer Treatment|3||N|N|||2|||||N|N
RA||LSY|Ultrasound,Hyperthermia, Cancer Treatment|3||N|N|||2|||||N|N
RA||MJS|Contrast Media, Ultrasound|3||N|N|||2|||||N|N
RA||MOT|Irradiator, Blood To Prevent Graft Versus Host Disease|U|1|N|N|||1|||||N|N
RA||MYN|Analyzer,Medical Image|3||N|N|||2|||||N|N
RA||NAN|Tester,Acoustic,Bone Quality|3||N|N|||2|||||N|N
RA||NAW|Microspheres Radionuclide|3||N|N|||2|Approved PMA:  P990065||||Y|N
RA||NCL|Imager, Breast, Electrical Impedance|3||N|N|||2|||||N|N
RA||OLQ|Cross-Sectional Mammographic Xray System|3||N|N|||2|Diagnostic breast imaging.  Imaging of the breast by cross-sectional x-ray imaging for diagnostic purposes.|medical diagnostic x-ray imaging system|x-ray imaging|breast|N|N
RA||OTE|Digital Breast Tomosynthesis|3||N|N|||2|To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.|Hardware and software for acquiring and reconstructing digital projection images. May incorporate similar equipment as full-field digital mammography systems.|Projection images are acquired over the stationary breast and reconstructed to produce cross-sectional ¿slices¿ through the breast.|Breast|N|N
RA||OVB|Hydrogel Spacer|N|3|N|N|||3|To temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent  to reduce the radiation dose delivered to the anterior rectum.|Synthetic, absorbable polyethylene glycol (PEG)-based hydrogel supplied in a single use tray|Injected in tissue found between the rectum and prostate.  The injected liquid solidifies creating a space between the rectum and prostate during radiation therapy to protect vulnerable tissue.  It gradually liquifies and is absorbed.|Between the prostate and the rectum|N|N
RA||PAA|Automated Breast Ultrasound|3||N|N|||2|Adjunct to mammography for breast cancer screening and diagnosis.|May include different transducers|Uses an automatic method of acquiring ultrasound images of the breast|Breast|N|N
SU|AN|NDC|Calculator, Drug Dose|2||N|P||868.1890|1|||||N|N
SU|AN|PDT|Burn Resuscitation Decision Support Software|2||N|N||868.1890|1|The burn resuscitation decision support system (BRDSS) is intended for use in prediction of hourly fluid volume during initial 24 hours of burn resuscitation. It is intended for patients who have greater than 20% total body surface area burn.|Software that is accessed through hardware that provides user interface through screen displays.|BRDSS is a software based calculator that uses an algorithm to calculate resuscitation volume using physiological data inputs. The algorithm used is developed by the manufacturer and may not be the typical algorithm used in standard practice to calculate fluid management for burn patients.|None. The fluid volume calculated by the software will affect systemic, total body fluid homeostasis.|N|N
SU|EN|MIB|Elastomer, Silicone Block|2||N|N||874.3620|1|||||Y|N
SU|GU|GCJ|Laparoscope, General & Plastic Surgery|2||N|Y|M|876.1500|1|||||N|N
SU|GU|MFJ|Device, Endoscopic Suturing|2||N|N||876.1500|1|||||N|N
SU|GU|NAY|System,Surgical,Computer Controlled Instrument|2||N|N||876.1500|1|||||N|N
SU|GU|NEQ|Device, Telemedicine, Robotic|2||N|N||876.1500|1|||||N|N
SU|GU|NGU|Balloon, Liver Tamponade|2||N|P||876.5980|1|||||N|N
SU|GU|OEJ|Transurethral Electrosurgical Unit, Benign Prostatic Hyperplasia|2||N|N||876.4300|1|Ablation of prostatic tissue for the treatment of benign prostatic hyperplasia|The device consists primarily of a radio frequency generator and an applicator.  The applicator is inserted into the urethra and positions the electrodes appropriately for delivery of RF energy transurethrally to the prostate.|Radio frequency energy is applied to the prostate using electrodes.  Resistive heating of the prostatic tissue leads to necrotic death or direct ablation depending on the temperatures achieved.|Prostate|N|N
SU|GU|OEK|Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia|2||N|N||876.4300|1|Thermotherapy and dilation of prostatic tissue for the treatment of benign prostatic hyperplasia|The device consists primarily of a water heating unit and an applicator.  The applicator is a catheter-like device inserted into the urethra.  The dilation balloon and the heat conductive area of the applicator are positioned in the prostatic urethra.|The prostate is heated by means of hot water passed through an applicator and dilated by a balloon.  Radio frequency energy is applied to the prostate using electrodes.  Conductive heating and dilation of the prostatic urethra produces relief of symptoms of BPH.|Prostate|N|N
SU|GU|OTJ|Laparoscopic Single Port Access Device|2||N|N||876.1500|1|A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.|multiple laparoscopic trocars and insufflation tube(s) bound by a flexible foam port.|This device utilizes multiple laparoscopic trocars and insufflation tube(s) bound by a flexible foam port. The flexibility of the port enables laparoscopic instruments to be moved at different angles relative to each other.|abdominal|N|N
SU|GU|OWN|Confocal Optical Imaging|2||N|N||876.1500|1|Collection of light signals for visualization of cellular microstructures.|Usually include optical fibers, light collection cameras and computer-based central processing unit|Collects reflected and scattered light signals from the areas of interest for image reconstruction|soft tissue, blood vessel and other vessels in the body|N|N
SU|HO|FPY|Sheet, Burn|1||N|N||880.5180|4|||||N|N
SU|HO|KGX|Tape And Bandage, Adhesive|1||N|N||880.5240|4|||||N|N
SU|HO|KMF|Bandage, Liquid|1||N|Y|M|880.5090|1|||||N|N
SU|HO|LWH|Counter, Sponge, Surgical|1||N|N||880.2740|4|||||N|N
SU|HO|MCY|Kit, Wound Dressing|2||N|N||880.5075|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
SU|HO|MHW|Dressing, Compression|1||N|N||880.5075|4|||||N|N
SU|HO|NEC|Bandage, Liquid, Skin Protectant|1||N|Y||880.5090|4|||||N|N
SU|HO|PBZ|Image Processing Device For Estimation Of External Blood Loss|2||N|N||880.2750|1|An image processing device for estimation of external blood loss is a device to be used as an aid in estimation of patient external blood loss.  The device may include software and/or hardware that is used to process images capturing externally lost blood to estimate the hemoglobin mass and/or the blood volume present in the images.|Software and Hardware system.|A software algorithm analyzes recorded images of surgical sponges to estimate hemoglobin mass.|General Surgery|N|N
SU|NE|OEW|Tracking, Soft Tissue, Intraoperative|2||N|N||882.4560|1|For open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.|a PC with LCD monitor for displaying images, tracked laser range scanner, tracked fixed reference emitter, tracked localization probe with infrared emitting dioodes, and three lens active-based optical position sensor|the device uses optical, infrared light tracking systems for localizing surgical tools and a camera for spatial reconstruction of tool alignment and position|soft tissue|N|Y
SU|NE|ONA|Computer Assisted Hair Harvesting System|2||N|N||882.4560|1|A computer assisted harvesting system used in identifying and extracting hair follicular units and indicated to assist surgeon in identifying and extracting hair follicular units during hair transplantation.|computer assisted station with needle mechanism, force sensor, robotic arm and video imaging system|computer assisted harvesting sysem|scalp|N|N
SU|PM|OAP|Laser, Comb, Hair|2||N|N||890.5500|1|Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v|Light emitting stimulator|Pass laser light emitting comb across the scalp three times a week for at least 26 weeks.|Growth of scalp hairs|N|N
SU|RA|NQQ|System, Imaging, Optical Coherence Tomography (Oct)|2||N|N||892.1560|1|This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.||||N|N
SU|SU|BTA|Pump, Portable, Aspiration (Manual Or Powered)|2||N|Y|M|878.4780|1|||||N|N
SU|SU|BTX|Board, Arm (With Cover), Sterile|1||N|N||878.3910|4|||||N|N
SU|SU|BWA|Unit, Electrosurgical Andcoagulation, With Accessories|2||N|Y|M|878.4400|1|||||N|N
SU|SU|BWN|Table And Attachments, Operating-Room|1||N|N||878.4950|4|||||N|N
SU|SU|BWP|Shoe And Shoe Cover, Conductive|1||N|N||878.4040|4|||||N|N
SU|SU|DWG|Electrosurgical Device|2||N|Y|M|878.4400|1|||||N|N
SU|SU|DWH|Blade, Saw, Surgical, Cardiovascular|1||N|N||878.4820|4|||||N|N
SU|SU|DWI|Saw, Electrically Powered|1||N|N||878.4820|4|||||N|N
SU|SU|DWO|Needle, Biopsy, Cardiovascular|1||N|N||878.4800|4|||||N|N
SU|SU|EMF|Knife, Surgical|1||N|N||878.4800|4|||||N|N
SU|SU|EPT|Microscope, Surgical|1||N|N||878.4700|4|||||N|N
SU|SU|EPY|Speculum, Ent|1||N|N||878.1800|4|||||N|N
SU|SU|ERY|Drape, Surgical, Ent|2||N|P||878.4370|4|||||N|N
SU|SU|ESF|Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent|2||N|N||878.3500|1|||||Y|N
SU|SU|EYR|Tourniquet, Gastro-Urology|1||N|N||878.5900|4|||||N|N
SU|SU|EYX|Drape, Pure Latex Sheet, With Self-Retaining Finger Cot|2||N|P||878.4370|4|||||N|N
SU|SU|EYY|Drape, Urological, Disposable|2||N|P||878.4370|4|||||N|N
SU|SU|EZX|Mesh, Surgical, Metal|2||N|N||878.3300|1|||||Y|N
SU|SU|FAZ|System, Cryosurgical, Liquid Nitrogen, For Urology|2||N|P||878.4350|1|||||N|N
SU|SU|FGY|Cannula, Injection|1||N|N||878.4200|4|||||N|N
SU|SU|FHM|Apparatus, Suturing, Stomach And Intestinal|1||N|N||878.4800|4|||||N|N
SU|SU|FHR|Needle, Gastro-Urology|1||N|N||878.4800|4|||||N|N
SU|SU|FLJ|Unit, Airflow, Laminar|2||N|P||878.5070|1|||||N|N
SU|SU|FMK|Lancet, Blood|1||N|N||878.4800|4|||||N|N
SU|SU|FNW|Pad, Kelly|2||N|P||878.4370|4|||||N|N
SU|SU|FQO|Table, Operating-Room, Ac-Powered|1||N|N||878.4960|4|||||N|N
SU|SU|FQP|Lamp, Operating-Room|2||N|Y|M|878.4580|4|||||N|N
SU|SU|FRT|Unit, Isolation, Surgical|2||N|P||878.5070|1|||||N|N
SU|SU|FSE|Table, Operating-Room, Manual|1||N|N||878.4950|4|||||N|N
SU|SU|FSM|Tray, Surgical, Instrument|1||N|N||878.4800|4|||||N|N
SU|SU|FSO|Microscope, Surgical, General & Plastic Surgery|1||N|N||878.4700|4|||||N|N
SU|SU|FSP|Loupe, Diagnostic/Surgical|1||N|N||878.4800|4|||||N|N
SU|SU|FSQ|Light, Surgical, Instrument|2||N|Y|M|878.4580|4|||||N|N
SU|SU|FSS|Light, Surgical, Floor Standing|2||N|Y|M|878.4580|4|||||N|N
SU|SU|FST|Light, Surgical, Fiberoptic|2||N|Y|M|878.4580|1|||||N|N
SU|SU|FSW|Light, Surgical, Endoscopic|2||N|Y|M|878.4580|4|||||N|N
SU|SU|FSX|Light, Surgical, Connector|2||N|Y|M|878.4580|4|||||N|N
SU|SU|FSY|Light, Surgical, Ceiling Mounted|2||N|Y|M|878.4580|4|||||N|N
SU|SU|FSZ|Light, Surgical, Carrier|2||N|Y|M|878.4580|4|||||N|N
SU|SU|FTA|Light, Surgical, Accessories|2||N|Y|M|878.4580|4|||||N|N
SU|SU|FTC|Light, Ultraviolet, Dermatological|2||N|P||878.4630|1|||||N|N
SU|SU|FTD|Lamp, Surgical|2||N|Y|M|878.4580|4|||||N|N
SU|SU|FTF|Illuminator, Non-Remote|2||N|Y|M|878.4580|1|||||N|N
SU|SU|FTG|Illuminator, Remote|2||N|Y|M|878.4580|4|||||N|N
SU|SU|FTH|Camera, Still, Microsurgical|1||N|N||878.4160|4|||||N|N
SU|SU|FTL|Mesh, Surgical, Polymeric|2||N|N||878.3300|1|||||Y|N
SU|SU|FTM|Mesh, Surgical|2||N|N||878.3300|1|||||Y|N
SU|SU|FTN|Kit, Plastic Surgery And Accessories|1||N|N||878.3925|4|||||N|N
SU|SU|FTR|Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled|3||N|N||878.3540|2|Call for pmas to be filed by 7/9/91 per 56 fr 14627 on 4/10/91||||Y|N
SU|SU|FTS|Camera, Cine, Endoscopic, With Audio|1||N|N||878.4160|4|||||N|N
SU|SU|FTT|Camera, Still, Surgical|1||N|N||878.4160|4|||||N|N
SU|SU|FTX|Mirror, General & Plastic Surgery|1||N|N||878.4800|4|||||N|N
SU|SU|FTY|Tape, Measuring, Rulers And Calipers|1||N|N||878.4800|4|||||N|N
SU|SU|FWB|Camera, Television, Surgical, Without Audio|1||N|N||878.4160|4|||||N|N
SU|SU|FWC|Camera, Television, Surgical, With Audio|1||N|N||878.4160|4|||||N|N
SU|SU|FWD|Camera, Television, Microsurgical, Without Audio|1||N|N||878.4160|4|||||N|N
SU|SU|FWE|Camera, Television, Microsurgical, With Audio|1||N|N||878.4160|4|||||N|N
SU|SU|FWF|Camera, Television, Endoscopic, Without Audio|1||N|N||878.4160|4|||||N|N
SU|SU|FWG|Camera, Television, Endoscopic, With Audio|1||N|N||878.4160|4|||||N|N
SU|SU|FWH|Camera, Cine, Surgical, Without Audio|1||N|N||878.4160|4|||||N|N
SU|SU|FWI|Camera, Cine, Surgical, With Audio|1||N|N||878.4160|4|||||N|N
SU|SU|FWJ|Camera, Cine, Microsurgical, Without Audio|1||N|N||878.4160|4|||||N|N
SU|SU|FWK|Camera, Cine, Microsurgical, With Audio|1||N|N||878.4160|4|||||N|N
SU|SU|FWL|Camera, Cine, Endoscopic, Without Audio|1||N|N||878.4160|4|||||N|N
SU|SU|FWM|Prosthesis, Breast, Inflatable, Internal, Saline|3||N|N||878.3530|2|Call for PMAs to be filed by 11/17/99 per 64 FR 45161 on 8/19/99||||Y|N
SU|SU|FWP|Prosthesis, Chin, Internal|2||N|N||878.3550|1|||||Y|N
SU|SU|FWW|Table, Operating-Room, Pneumatic|1||N|N||878.4960|4|||||N|N
SU|SU|FWX|Table, Operating-Room, Mechanical|1||N|N||878.4950|4|||||N|N
SU|SU|FWY|Table, Operating-Room, Non-Electrical|1||N|N||878.4950|4|||||N|N
SU|SU|FWZ|Accessories, Operating-Room, Table (Kit)|1||N|N||878.4950|4|||||N|N
SU|SU|FXE|Speculum, Non-Illuminated|1||N|N||878.1800|4|||||N|N
SU|SU|FXF|Speculum, Illuminated|1||N|N||878.1800|4|||||N|N
SU|SU|FXG|Specula Accessories|1||N|N||878.1800|4|||||N|N
SU|SU|FXM|Camera, Still, Endoscopic|1||N|N||878.4160|4|||||N|N
SU|SU|FXN|Tape, Camera, Surgical|1||N|N||878.4160|4|||||N|N
SU|SU|FXO|Suit, Surgical|1||N|N||878.4040|4|||||N|N
SU|SU|FXP|Cover, Shoe, Operating-Room|1||N|N||878.4040|4|||||N|N
SU|SU|FXQ|Lens, Camera, Surgical|1||N|N||878.4160|4|||||N|N
SU|SU|FXR|Holder, Camera, Surgical|1||N|N||878.4160|4|||||N|N
SU|SU|FXS|Frame, Camera, Surgical|1||N|N||878.4160|4|||||N|N
SU|SU|FXT|Film, Camera, Surgical|1||N|N||878.4160|4|||||N|N
SU|SU|FXW|Shoes, Operating-Room|1||N|N||878.4040|4|||||N|N
SU|SU|FXX|Mask, Surgical|2||N|P||878.4040|1|||||N|N
SU|SU|FXY|Hood, Surgical|2||N|P||878.4040|1|||||N|N
SU|SU|FXZ|Helmet, Surgical|1||N|N||878.4040|4|||||N|N
SU|SU|FYA|Gown, Surgical|2||N|P||878.4040|1|||||N|N
SU|SU|FYB|Gown, Patient|2||N|P||878.4040|1|||||N|N
SU|SU|FYC|Gown, Isolation, Surgical|2||N|P||878.4040|1|||||N|N
SU|SU|FYD|Apparatus, Exhaust, Surgical|2||N|P||878.5070|1|||||N|N
SU|SU|FYE|Dress, Surgical|1||N|N||878.4040|4|||||N|N
SU|SU|FYF|Cap, Surgical|1||N|N||878.4040|4|||||N|N
SU|SU|FYH|Splint, Extremity, Noninflatable, External, Sterile|1||N|N||878.3910|4|||||N|N
SU|SU|FYI|Appliance, Facial Fracture, External|1||N|N||878.3250|4|||||N|N
SU|SU|FZD|Prosthesis, Ear, Internal|2||N|N||878.3590|1|||||Y|N
SU|SU|FZE|Prosthesis, Nose, Internal|2||N|N||878.3680|1|||||Y|N
SU|SU|FZF|Splint, Extremity, Inflatable, External|1||N|N||878.3900|4|||||N|N
SU|SU|FZG|Apparatus, Air Handling, Bench|2||N|P||878.5070|4|||||N|N
SU|SU|FZH|Apparatus, Air Handling, Room|2||N|P||878.5070|4|||||N|N
SU|SU|FZI|Apparatus, Air Handling, Enclosure|2||N|P||878.5070|4|||||N|N
SU|SU|FZK|Chair, Surgical, Non-Electrical|1||N|N||878.4950|4|||||N|N
SU|SU|FZM|Stool, Operating-Room|1||N|N||878.4950|4|||||N|N
SU|SU|FZO|Chisel, Surgical, Manual|1||N|N||878.4800|4|||||N|N
SU|SU|FZP|Clip, Implantable|2||N|N||878.4300|1|||||Y|N
SU|SU|FZQ|Clip, Removable (Skin)|1||N|N||878.4320|4|||||N|N
SU|SU|FZR|Contractor, Surgical|1||N|N||878.4800|4|||||N|N
SU|SU|FZS|Curette, Surgical, General Use|1||N|N||878.4800|4|||||N|N
SU|SU|FZT|Cutter, Surgical|1||N|N||878.4800|4|||||N|N
SU|SU|FZW|Expander, Surgical, Skin Graft|1||N|N||878.4800|4|||||N|N
SU|SU|FZX|Guide, Surgical, Instrument|1||N|N||878.4800|4|||||N|N
SU|SU|FZY|Hammer, Surgical|1||N|N||878.4800|4|||||N|N
SU|SU|FZZ|Marker, Skin|1||N|N||878.4660|4|||||N|N
SU|SU|GAA|Needle, Aspiration And Injection, Disposable|1||N|N||878.4800|4|||||N|N
SU|SU|GAB|Needle, Suturing, Disposable|1||N|N||878.4800|4|||||N|N
SU|SU|GAC|Rasp, Surgical, General & Plastic Surgery|1||N|N||878.4800|4|||||N|N
SU|SU|GAD|Retractor|1||N|N||878.4800|4|||||N|N
SU|SU|GAE|Snare, Surgical|1||N|N||878.4800|4|||||N|N
SU|SU|GAF|Spatula, Surgical, General & Plastic Surgery|1||N|N||878.4800|4|||||N|N
SU|SU|GAG|Stapler, Surgical|1||N|N||878.4800|4|||||N|N
SU|SU|GAH|Stylet, Surgical, General & Plastic Surgery|1||N|N||878.4800|4|||||N|N
SU|SU|GAI|Stripper, Vein, Reusable|1||N|N||878.4800|4|||||N|N
SU|SU|GAJ|Stripper, Vein, Disposable|1||N|N||878.4800|4|||||N|N
SU|SU|GAK|Suture, Absorbable|2||N|N||878.4830|1|||||Y|N
SU|SU|GAL|Suture, Absorbable, Natural|2||N|N||878.4830|1|||||Y|N
SU|SU|GAM|Suture, Absorbable, Synthetic, Polyglycolic Acid|2||N|N||878.4493|1|||||Y|N
SU|SU|GAN|Suture, Absorbable, Synthetic|2||N|N||878.4830|1|||||Y|N
SU|SU|GAP|Suture, Nonabsorbable, Silk|2||N|N||878.5030|1|||||Y|N
SU|SU|GAQ|Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile|2||N|N||878.4495|1|||||Y|N
SU|SU|GAR|Suture, Nonabsorbable, Synthetic, Polyamide|2||N|N||878.5020|1|||||Y|N
SU|SU|GAS|Suture, Nonabsorbable, Synthetic, Polyester|2||N|N||878.5000|1|||||Y|N
SU|SU|GAT|Suture, Nonabsorbable, Synthetic, Polyethylene|2||N|N||878.5000|1|||||Y|N
SU|SU|GAW|Suture, Nonabsorbable, Synthetic, Polypropylene|2||N|N||878.5010|1|||||Y|N
SU|SU|GAX|Tourniquet, Nonpneumatic|1||N|N||878.5900|4|||||N|N
SU|SU|GBA|Catheter, Balloon Type|1||N|N||878.4200|4|||||N|N
SU|SU|GBB|Chair, Surgical, Ac-Powered|1||N|N||878.4960|4|||||N|N
SU|SU|GBC|Lamp, Surgical, Incandescent|2||N|Y|M|878.4580|4|||||N|N
SU|SU|GBI|Material, External Aesthetic Restoration, Used With Adhesive|1||N|N||878.3800|4|||||N|N
SU|SU|GBJ|Prosthesis, Adhesive, External|1||N|N||878.3750|4|||||N|N
SU|SU|GBN|Catheter, Pediatric, General & Plastic Surgery|1||N|N||878.4200|4|||||N|N
SU|SU|GBO|Catheter, Nephrostomy, General & Plastic Surgery|1||N|N||878.4200|4|||||N|N
SU|SU|GBP|Catheter, Multiple Lumen|1||N|N||878.4200|4|||||N|N
SU|SU|GBQ|Catheter, Continuous Irrigation|1||N|N||878.4200|4|||||N|N
SU|SU|GBS|Catheter, Ventricular, General & Plastic Surgery|1||N|N||878.4200|4|||||N|N
SU|SU|GBW|Catheter, Peritoneal|1||N|N||878.4200|4|||||N|N
SU|SU|GBX|Catheter, Irrigation|1||N|N||878.4200|4|||||N|N
SU|SU|GBY|Catheter, Eustachian, General & Plastic Surgery|1||N|N||878.4200|4|||||N|N
SU|SU|GBZ|Catheter, Cholangiography|1||N|N||878.4200|4|||||N|N
SU|SU|GCB|Needle, Catheter|1||N|N||878.4200|4|||||N|N
SU|SU|GCC|Dilator, Catheter|1||N|N||878.4200|4|||||N|N
SU|SU|GCD|Connector, Catheter|1||N|N||878.4200|4|||||N|N
SU|SU|GCE|Adaptor, Catheter|1||N|N||878.4200|4|||||N|N
SU|SU|GCY|Apparatus, Suction, Single Patient Use, Portable, Nonpowered|1||N|N||878.4680|4|||||N|N
SU|SU|GCZ|Retainer, Surgical|1||N|N||878.4800|4|||||N|N
SU|SU|GDC|Table, Operating-Room, Electrical|1||N|N||878.4960|4|||||N|N
SU|SU|GDF|Guide, Needle, Surgical|1||N|N||878.4800|4|||||N|N
SU|SU|GDG|Hook, Surgical, General & Plastic Surgery|1||N|N||878.4800|4|||||N|N
SU|SU|GDH|Gouge, Surgical, General & Plastic Surgery|1||N|N||878.4800|4|||||N|N
SU|SU|GDI|Dissector, Surgical, General & Plastic Surgery|1||N|N||878.4800|4|||||N|N
SU|SU|GDJ|Clamp, Surgical, General & Plastic Surgery|1||N|N||878.4800|4|||||N|N
SU|SU|GDL|Needle, Suturing, Reusable|1||N|N||878.4800|4|||||N|N
SU|SU|GDM|Needle, Aspiration And Injection, Reusable|1||N|N||878.4800|4|||||N|N
SU|SU|GDN|Knife, Amputation|1||N|N||878.4800|4|||||N|N
SU|SU|GDO|Applier, Surgical, Clip|1||N|N||878.4800|4|||||N|N
SU|SU|GDR|Saw, Manual And Accessories|1||N|N||878.4800|4|||||N|N
SU|SU|GDT|Staple, Removable (Skin)|1||N|N||878.4760|4|||||N|N
SU|SU|GDW|Staple, Implantable|2||N|N||878.4750|1|||||Y|N
SU|SU|GDX|Scalpel, One-Piece|1||N|N||878.4800|4|||||N|N
SU|SU|GDY|Gauze/Sponge, Internal, X-Ray Detectable|1||N|N||878.4450|4|||||N|N
SU|SU|GDZ|Handle, Scalpel|1||N|N||878.4800|4|||||N|N
SU|SU|GEA|Cannula, Surgical, General & Plastic Surgery|1||N|N||878.4800|4|||||N|N
SU|SU|GEC|Brush, Scrub, Operating-Room|1||N|N||878.4800|4|||||N|N
SU|SU|GED|Brush, Dermabrasion, Manual|1||N|N||878.4800|4|||||N|N
SU|SU|GEE|Brush, Biopsy, General & Plastic Surgery|1||N|N||878.4800|4|||||N|N
SU|SU|GEF|Applier, Staple, Surgical,|1||N|N||878.4800|4|||||N|N
SU|SU|GEG|Elevator, Surgical, General & Plastic Surgery|1||N|N||878.4800|4|||||N|N
SU|SU|GEH|Unit, Cryosurgical, Accessories|2||N|P||878.4350|1|||||N|N
SU|SU|GEI|Electrosurgical, Cutting & Coagulation & Accessories|2||N|Y|M|878.4400|1|||||N|N
SU|SU|GEJ|Carrier, Ligature|1||N|N||878.4800|4|||||N|N
SU|SU|GEN|Forceps, General & Plastic Surgery|1||N|N||878.4800|4|||||N|N
SU|SU|GEO|File, Surgical, General & Plastic Surgery|1||N|N||878.4800|4|||||N|N
SU|SU|GES|Blade, Scalpel|1||N|N||878.4800|4|||||N|N
SU|SU|GET|Motor, Surgical Instrument, Pneumatic Powered|1||N|N||878.4820|4|||||N|N
SU|SU|GEX|Powered Laser Surgical Instrument|2||N|Y||878.4810|1|"a laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. The classification regulation 21 cfr 878.4810  describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.||||N|N
SU|SU|GEY|Motor, Surgical Instrument, Ac-Powered|1||N|N||878.4820|4|||||N|N
SU|SU|GFA|Blade, Saw, General & Plastic Surgery, Surgical|1||N|N||878.4820|4|||||N|N
SU|SU|GFB|Head, Surgical, Hammer|1||N|N||878.4820|4|||||N|N
SU|SU|GFC|Driver, Surgical, Pin|1||N|N||878.4820|4|||||N|N
SU|SU|GFD|Dermatome|1||N|N||878.4820|4|||||N|N
SU|SU|GFE|Brush, Dermabrasion, Powered|1||N|N||878.4820|4|||||N|N
SU|SU|GFF|Bur, Surgical, General & Plastic Surgery|1||N|N||878.4820|4|||||N|N
SU|SU|GFG|Bit, Surgical|1||N|N||878.4820|4|||||N|N
SU|SU|GFI|Osteotome, Manual|1||N|N||878.4800|4|||||N|N
SU|SU|GFJ|Mallet, Surgical, General & Plastic Surgery|1||N|N||878.4800|4|||||N|N
SU|SU|HAB|Saw, Powered, And Accessories|1||N|N||878.4820|4|||||N|N
SU|SU|HAM|Apparatus, Electrosurgical|2||N|Y|M|878.4400|1|||||N|N
SU|SU|HBI|Illuminator, Fiberoptic, Surgical Field|2||N|Y|M|878.4580|1|||||N|N
SU|SU|HBT|Applier, Hemostatic Clip|1||N|N||878.4800|4|||||N|N
SU|SU|HCF|Instrument, Ligature Passing And Knot Tying|1||N|N||878.4800|4|||||N|N
SU|SU|HJE|Lamp, Fluorescein, Ac-Powered|2||N|Y|M|878.4580|1|||||N|N
SU|SU|HMP|Pad, Eye|1||N|N||878.4440|4|||||N|N
SU|SU|HMT|Drape, Patient, Ophthalmic|2||N|P||878.4370|4|||||N|N
SU|SU|HMW|Drape, Microscope, Ophthalmic|2||N|P||878.4370|4|||||N|N
SU|SU|HRB|Microscope, Operating, Non-Electric, Ophthalmic|1||N|N||878.4700|4|||||N|N
SU|SU|HRM|Microscope, Operating & Accessories, Ac-Powered, Ophthalmic|1||N|N||878.4700|4|||||N|N
SU|SU|HRQ|Hemostat|1||N|N||878.4800|4|||||N|N
SU|SU|HSO|Saw|1||N|N||878.4800|4|||||N|N
SU|SU|HTC|Pliers, Surgical|1||N|N||878.4800|4|||||N|N
SU|SU|HTD|Forceps|1||N|N||878.4800|4|||||N|N
SU|SU|HTE|Elevator|1||N|N||878.4800|4|||||N|N
SU|SU|HTF|Curette|1||N|N||878.4800|4|||||N|N
SU|SU|HTR|Rasp|1||N|N||878.4800|4|||||N|N
SU|SU|HTZ|Instrument, Cutting, Orthopedic|1||N|N||878.4800|4|||||N|N
SU|SU|HWM|Osteotome|1||N|N||878.4800|4|||||N|N
SU|SU|HXD|Clamp|1||N|N||878.4800|4|||||N|N
SU|SU|HXL|Mallet|1||N|N||878.4800|4|||||N|N
SU|SU|HXR|Spatula, Orthopedic|1||N|N||878.4800|4|||||N|N
SU|SU|HXT|Tape, Orthopedic|1||N|N||878.4800|4|||||N|N
SU|SU|HYA|Forceps, Wire Holding|1||N|N||878.4800|4|||||N|N
SU|SU|JCQ|Prosthesis, Esophagus|2||N|N||878.3610|1|||||Y|N
SU|SU|JCT|Prosthesis, Tracheal, Expandable|2||N|N||878.3720|1|||||Y|N
SU|SU|JCX|Apparatus, Suction, Ward Use, Portable, Ac-Powered|2||N|Y|M|878.4780|1|||||N|N
SU|SU|JCY|Catheter, Infusion|1||N|N||878.4200|4|||||N|N
SU|SU|JDJ|Mesh, Surgical, Acetabular, Hip, Prosthesis|2||N|N||878.3300|1|||||Y|N
SU|SU|JDK|Prosthesis, Hip, Cement Restrictor|2||N|N||878.3300|1|||||Y|N
SU|SU|JEA|Table, Surgical With Orthopedic Accessories, Ac-Powered|1||N|N||878.4960|4|||||N|N
SU|SU|JEB|Table, Surgical With Orthopedic Accessories, Manual|1||N|N||878.4950|4|||||N|N
SU|SU|JOS|Electrode, Electrosurgical|2||N|Y|M|878.4400|1|||||N|N
SU|SU|JOT|Electrode, Gel, Electrosurgical|2||N|Y|M|878.4400|1|||||N|N
SU|SU|JYC|Cannula, Ear|1||N|N||878.4800|4|||||N|N
SU|SU|JYD|Chisel, Mastoid|1||N|N||878.4800|4|||||N|N
SU|SU|JYK|Holder, Ear Speculum|1||N|N||878.1800|4|||||N|N
SU|SU|KAG|Holder, Speculum, Ent|1||N|N||878.1800|4|||||N|N
SU|SU|KAM|Cannula, Sinus|1||N|N||878.4800|4|||||N|N
SU|SU|KAN|Chisel, Nasal|1||N|N||878.4800|4|||||N|N
SU|SU|KCE|Cannulae, Bronchial|1||N|N||878.4800|4|||||N|N
SU|SU|KCW|Epilator, High Frequency, Needle-Type|1||N|N||878.5350|4|||||N|N
SU|SU|KCX|Epilator, High Frequency, Tweezer-Type|1||N|N||878.5360|4|||||N|N
SU|SU|KCY|Tourniquet, Pneumatic|1||N|N||878.5910|4|||||N|N
SU|SU|KCZ|Prosthesis, Breast, External, Used With Adhesive|1||N|N||878.3800|4|||||N|N
SU|SU|KDA|Prosthesis, Ptfe/Carbon-Fiber|2||N|N||878.3500|1|||||Y|N
SU|SU|KDC|Instrument, Surgical, Disposable|1||N|N||878.4800|4|||||N|N
SU|SU|KDD|Kit, Surgical Instrument, Disposable|1||N|N||878.4800|4|||||N|N
SU|SU|KDG|Chisel (Osteotome)|1||N|N||878.4820|4|||||N|N
SU|SU|KFK|Saw, Pneumatically Powered|1||N|N||878.4820|4|||||N|N
SU|SU|KGL|Cabinet, Phototherapy (Puva)|2||N|N||878.4630|1|||||N|N
SU|SU|KGO|Surgeon'S Gloves|1||N|Y|M|878.4460|1|A surgeon's glove is a disposable device made of natural rubber latex that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.||||N|N
SU|SU|KGP|Powder, Dusting, Surgical|3||N|N||878.4480|2|||||N|N
SU|SU|KGQ|Cream, Gloving, Surgeon'S|1||N|N||878.4470|4|||||N|N
SU|SU|KGS|Retention Device, Suture|1||N|N||878.4930|4|||||N|N
SU|SU|KGT|Drape, Adhesive, Aerosol|1||N|N||878.4380|4|||||N|N
SU|SU|KGW|Ring (Wound Protector), Drape Retention, Internal|2||N|P||878.4370|4|||||N|N
SU|SU|KGY|Bag, Intestine|1||N|N||878.4100|4|||||N|N
SU|SU|KGZ|Accessories, Catheter|1||N|N||878.4200|4|||||N|N
SU|SU|KIK|Hook, Bone|1||N|N||878.4800|4|||||N|N
SU|SU|KKX|Drape, Surgical|2||N|P||878.4370|4|||||N|N
SU|SU|KKY|Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction|2||N|N||878.3500|1|||||Y|N
SU|SU|KOX|Solvent, Adhesive Tape|1||N|N||878.4730|4|||||N|N
SU|SU|KOY|Degreaser, Skin, Surgical|1||N|N||878.4730|4|||||N|N
SU|SU|KOZ|Beads, Hydrophilic, For Wound Exudate Absorption|1||N|N||878.4018|4|||||N|N
SU|SU|KPJ|Chamber, Oxygen, Topical, Extremity|2||N|N||878.5650|1|||||N|N
SU|SU|KQM|Camera, Surgical And Accessories|1||N|N||878.4160|4|||||N|N
SU|SU|LEJ|Booth, Sun Tan|2||N|N||878.4635|1|||||N|N
SU|SU|LMF|Agent, Absorbable Hemostatic, Collagen Based|3||N|N||878.4490|2|||||Y|N
SU|SU|LMG|Agent, Absorbable Hemostatic, Non-Collagen Based|3||N|N||878.4490|2|||||Y|N
SU|SU|LRO|General Surgery Tray (Kit)|2||N|P||878.4370|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|N|N
SU|SU|LRP|Tray, Surgical|1||N|N||878.4800|4|||||N|N
SU|SU|LRW|Scissors, General, Surgical|1||N|N||878.4800|4|||||N|N
SU|SU|LRY|Punch, Surgical|1||N|N||878.4800|4|||||N|N
SU|SU|LRZ|Screwdriver, Surgical|1||N|N||878.4800|4|||||N|N
SU|SU|LSA|Vise, Bench, Surgical|1||N|N||878.4800|4|||||N|N
SU|SU|LWG|Surgical Table Cushion|1||N|N||878.4950|4|||||N|N
SU|SU|LWK|Razor, Surgical|1||N|N||878.4800|4|||||N|N
SU|SU|LXK|Scrapper, Skin Specimen|1||N|N||878.4800|4|||||N|N
SU|SU|LYU|Accessory, Surgical Apparel|1||N|N||878.4040|4|||||N|N
SU|SU|LYV|Label Or Tag, Sterile|1||N|N||878.4800|4|||||N|N
SU|SU|MCH|Clip, Hemostatic|2||N|N||878.4300|1|||||Y|N
SU|SU|MDA|Elastomer, Silicone, For Scar Management|1||N|N||878.4025|4|||||N|N
SU|SU|MDM|Instrument, Manual, Surgical, General Use|1||N|N||878.4800|4|||||N|N
SU|SU|MIJ|Needle, Tumor Localization|1||N|N||878.4800|4|||||N|N
SU|SU|MJG|Device, Percutaneous, Biopsy|1||N|N||878.4800|4|||||N|N
SU|SU|MKY|System, Skin Closure|1||N|N||878.4320|4|||||N|N
SU|SU|MNF|Implant, Temporal|2||N|N||878.3550|1|||||Y|N
SU|SU|MOQ|Battery, Replacement, Rechargeable|1||N|N||878.4820|4|||||N|N
SU|SU|MPN|Tissue Adhesive For The Topical Approximation Of Skin|2||N|N||878.4010|1|Docket number:  2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).||||N|N
SU|SU|MUL|Generator,Electrosurgical,Coagulation,Cancer|2||N|Y||878.4400|1|||||N|N
SU|SU|MUU|System, Suction, Lipoplasty|2||N|P||878.5040|1|||||N|N
SU|SU|MXW|Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)|2||N|N||878.5010|1|||||Y|N
SU|SU|NAB|Gauze/Sponge,Nonresorbable For External Use|1||N|N||878.4014|4|||||N|N
SU|SU|NAC|Dressing,Wound,Hydrophilic|1||N|N||878.4018|4|||||N|N
SU|SU|NAD|Dressing,Wound,Occlusive|1||N|N||878.4020|4|||||N|N
SU|SU|NAE|Dressing,Wound,Hydrogel W/Out Drug And/Or Biologic|1||N|N||878.4022|4|||||N|N
SU|SU|NBY|Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene|2||N|N||878.5035|1|||||Y|N
SU|SU|NCA|Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)|2||N|N||878.4300|1|||||Y|N
SU|SU|NEH|Anchor, Fascial|2||N|N||878.4300|1|||||Y|N
SU|SU|NEU|Marker, Radiographic, Implantable|2||N|N||878.4300|1|||||Y|N
SU|SU|NEW|Suture, Surgical, Absorbable, Polydioxanone|2||N|N||878.4840|1|||||Y|N
SU|SU|NEY|System, Ablation, Microwave And Accessories|2||N|N||878.4400|1|||||N|N
SU|SU|NJC|Clip, Vas Deferens|2||N|N||878.4300|1|This is an implantable clip intended to ligate the vas deferens.  This is more specific than the regulation.||||Y|N
SU|SU|NJU|Suture, Nonabsorbable, Nitinol|2||N|N||878.4495|1|Soft tissue approximation.||||Y|N
SU|SU|NJZ|Extractor, Vein|1||N|N||878.4800|4|The device is a vein extractor that is pushed through the leg around the vein to effect saphenous vein harvesting.  It is like a long apple corer, but instead of taking out the apple core you are taking our someone's saphenous vein.||||N|N
SU|SU|NLK|Needle, Biopsy, Cardiovascular, Reprocessed|1||N|N||878.4800|1|||||N|N
SU|SU|NLL|Staple, Implantable, Reprocessed|2||N|N||878.4750|1|||||N|N
SU|SU|NMJ|Clip, Implantable, Reprocessed|2||N|N||878.4300|1|The "implantable clip, reprocessed" is intended to connect internal tissues to aid in healing.  It is not absorbable.  This device is indicated for reuse/reprocessing.||||Y|N
SU|SU|NMT|Needle, Catheter, Reprocessed|1||N|N||878.4200|1|||||N|N
SU|SU|NMU|Needle, Gastro-Urology, Reprocessed|1||N|N||878.4800|1|||||N|N
SU|SU|NNA|Biospy Device, Percutaneous, Reprocessed|1||N|N||878.4800|1|||||N|N
SU|SU|NNC|Needle, Aspiration And Needle, Reprocessed|1||N|N||878.4800|1|||||N|N
SU|SU|NOC|Splint, Extremity, Non-Inflatable, External, Non-Sterile|1||Y|N||878.3910|4|Non-inflatable extremity splint; See product code fyh.||||N|N
SU|SU|NOD|Board, Arm (Wtih Cover), Non-Sterile|1||Y|N||878.3910|4|||||N|N
SU|SU|NOJ|Prosthesis, Breast, External, No Adhesive|1||Y|N||878.3800|4|external aesthetic restoration prosthesis||||N|N
SU|SU|NOK|Material, External Aesthetic Restoration, No Adhesive|1||Y|N||878.3800|4|external aesthetic restoration prosthesis||||N|N
SU|SU|NRB|Wound Cleaner, Ultrasound|2||N|Y||878.4410|1|The ultrasound wound cleaner/mild debridement system is a device that delivers a cleaning fluid to the wound that is pulsed using low power ultrasound radiation.  The device is intended to clean and mildly debride wounds.  The ultrasound generator must deliver 1.0 mw/cm2 or less energy to the wound||||N|N
SU|SU|NRJ|Ultrasound, Skin Permeation|2||N|N||878.4410|1|Indicated for the temporary disruption of the outer layer of skin for the application of drugs, etc.||||N|N
SU|SU|NTB|System, Ablation, Ultrasound And Accessories|2||N|N||878.4400|1|Intended for use as a surgical tool for coagulation and ablation of soft tissue. This differs from the description in the regulation in that this device is not intended to cut tissue and this device uses high intensity ultrasound energy instead of electrosurgery or electrocautery.||||N|N
SU|SU|NUJ|Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed|2||N|N||878.4400|1|||||N|N
SU|SU|NUV|Massager, Vacuum, Light Induced Heating|2||N|N||878.4810|1|THE DEVICE IS INTENDED TO TEMPORARILY ALTER THE APPEARANCE OF CELLULITE||||N|N
SU|SU|NVH|Suture, Knot, Mechanical|2||N|N||878.5000|1|In approximation and/or ligation of soft tissue||||Y|N
SU|SU|NVJ|Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women|2||N|N||878.4400|1|Delivery of radio frequency energy to the submucosal tissue of the bladder neck and proximal urethra for the transurethral treatment of female stress urinary incontinence due to hypermobility.|Consists of radio frequency probe and generator and accessories.|Functions within a system.|Bladder neck and proximal urethra|N|N
SU|SU|NWA|Prosthesis, Tracheal, Preformed/Molded|2||N|N||878.3720|1|The device is intended to provide support to weakened or constricting airway walls.|The device is tubular and traditionally made of silicone. Devices can range roughly from 6-14mm in diameter and have lengths as small as 20 mm to lengths as long as 150mm.|The device functions independently providing physical support to the constricting airway.|The target area is the tracheobronchial tree|Y|N
SU|SU|NWF|Drill, Battery Powered, Subungual Hematoma|1||N|N||878.4820|4|Intended to cut a hole in finger and toe nails to release fluid accumulated in the underlying nail bed.  Indicated to relieve pressure from subungual hematomas (including black toe).|The device is comprised of a hand-held cutter, sensing electrodes and a battery pack.|The device uses a 6V cutter motor to rotate the cutter and a 6V vertical drive motor to move the cutter towards and away from the nail. The motors are powered by a 9V battery.|Finger nails and toe nails.|N|N
SU|SU|NWJ|Suture, Recombinant Technology|2||N|N||878.4494|1|Intended for use in soft tissue approximation.  Indicated for use in general soft tissue approximation and/or ligation.|Polymer (solid)|Produced through recombinant DNA technology|General soft tissues in the body.|Y|N
SU|SU|NXF|Gas, Laser Generating|1||N|N||878.4810|4|Special laser gas mixtures used as a lasing medium|Special laser gas mixtures used as a lasing medium|Special laser gas mixtures used as a lasing medium|Special laser gas mixtures used as a lasing medium|N|N
SU|SU|NYS|Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)|2||N|N||878.4015|1|A wound dressing with poly (diallyl dimethyl ammonium chloride) (pdadmac) additive is a device that is a sterile barrier wound dressing intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing.  The device consists of a textile substrate and permanently bound pdadmac.  The device acts as a physical barrier to outside contaminants and does not act on the surface or interior of the wound nor does it contain antimicrobial agents that act on the body.|Wound dressing|Topical application|exuding Wounds and first and second degree burns|N|N
SU|SU|NYT|Prosthesis, Tracheal, Expandable, Polymeric|2||N|N||878.3720|1|The device is intended to provide support to weakened or constricting airway walls and indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms or in benign strictures, after all alternative therapies have been exhausted.|The device is a self-expanding tubular device, traditionally made of silicone. Devices can range roughly from 6-14mm in diameter and have lengths as small as 20 mm to lengths as long as 150mm.|The device functions independently providing physical support to the constricting airway.|The target area is the tracheobronchial tree.|Y|N
SU|SU|OAB|Low Energy Direct Current Thermal Ablation System|2||N|N||878.4400|1|Ablation of soft tissue|it includes the LEDC generator, electrodes and accessories|it applies a low energy direct current (LEDC) pulse or series of pulses between two electrodes to cause an ablation effect to occur|soft tissue including cardiac and smooth muscle|N|N
SU|SU|ODR|Electrosurgical Patient Return Electrode|2||N|N||878.4400|1|Ground pad used to finish circuit during electrosurgery.  A single use, non-sterile dispersive electrode with a pre-attached cord used to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.|The electrode consists of five distinct layers of materials: the Mylar (protective cover) which is removed prior to use, Gel, Aluminum, Acrylic Adhesive and Blue Foam. The electrode construction consists of a dual aluminum electrode which connects to the generator during surgery. The aluminum is backed with a blue polyethylene foam pad with an acrylic adhesive which prevent fluid ingress. The aluminum is covered with a conductive Hydrogel adhesive.  The aluminum and the Hydrogel are the conductive layers.|Electrosurgical Patient Return Electrode is a single use, non-sterile disposable electrode with and without a pre-attached cord. The use is to complete an electrical circuit during electrosurgery between the generator, the active electrode, and an patient. It is furnished with a cord. The pad has a hydrogel adhesive for conductivity with an acrylic border to prevent invasion of fluids. Both pad designs are compatible with return electrode monitoring generator systems.|Thigh|N|N
SU|SU|ODU|Facial Implant|2||N|N||878.3500|1|For use in plastic and reconstructive surgery. The devices can be used for cosmetic augmentation and corrections of soft tissue deformities in the face, including areas such as the nose, chin, and cheeks.|Solid implants|Plastic surgery|face|Y|N
SU|SU|OEI|Drainage Catheter With Antibiotic|2||N|N||878.4780|1|A tubular drain made from silicone or similar material and is coated with a silver containing material and is intended to drain fluids from body cavities using gravity drainage or attached to a suction pump.|A tubular drain made from silicone or similar material and is coated with a silver containing material|Gravity drainage or attached to a suction pump|Normally any body cavity following surgery|N|N
SU|SU|OEL|Laser, Benign Prostatic Hyperplasia|2||N|N||878.4810|1|Laser ablation of prostatic tissue for the treatment of benign prostatic hyperplasia|The device consists primarily of medical laser and deliver fibers.  The fibers are positioned in the prostate or prostatic urethra through endoscopy and direct laser optical energy into the prostate.|Laser optical energy is applied to the prostate using endoscopically delivered fibers.  Heating of the prostatic tissue leads to necrotic death or direct ablation depending on the temperatures achieved.|Prostate|N|N
SU|SU|OHO|First Aid Kit Without Drug|1||N|N||878.4014|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
SU|SU|OHS|Light Based Over The Counter Wrinkle Reduction|2||N|N||878.4810|1|Use of light based treatment to reduce  wrinkles on the body in general or specific anatomical locations depending on the information provided.|The device can be hand held or mounted on a support system like a stand or mechanical arm.  The device will emit light that can be monochromatic or narrow band or broad band.  The light energy may be very low to moderate power levels.|Uses light based energy delivered to and or through the skin to effect change in the tissue that results in the reduction of wrinkles.|Mostly intended to be used on the human face, head, and neck.|N|N
SU|SU|OHT|Light Based Over-The-Counter Hair Removal|2||N|N||878.4810|1|Over-the-counter device uses thermal energy to kill hair follicles for hair removal.|Use of thermal energy|Use of thermal energy to kill hair follicles for hair removal|The device generally targets skin (including dermis, epidermis), underlying   soft tissue and hair follicles.|N|N
SU|SU|OHV|Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption|2||N|N||878.4590|1|A device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for non-invasive aesthetic use.|ultrasound|Use of focused ultrasound|soft tissue|N|N
SU|SU|OJR|Vacuum Powered Body Fluid Collection Kit|2||N|N||878.4780|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
SU|SU|OJS|Tourniquet Kit|1||N|N||878.5900|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
SU|SU|OJT|Aspiration Tray (Kit)|1||N|N||878.4800|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
SU|SU|OJU|Skin Prep Tray (Kit)|1||N|N||878.4800|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
SU|SU|OJV|Single Use Instrument Tray Kit|1||N|N||878.4800|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
SU|SU|OJW|Shave Prep Kit|2||N|N||878.4370|7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
SU|SU|OKJ|Light Based Treatment For Cold Sores Herpes Simplex Virus-1|2||N|N||878.4850|1|Shortens the time to healing as compared to untreated cold sores.  This is a treatment of individual herpes labialis lesions in persons infected with the herpes simplex virus.|Uses a 1072nm +/- 12nm peak wavelength on a cold sore for a period of approximately 3 minutes. The power source is a standard alkaline 9v battery, which is replaceable. Treatment with the cold sore machine is commenced at the first symptoms of a cold sore and repeated every 12 hours until healing commences. The treatment area is approximately 7 sq cm. The device is activated by the ON button, and automatically powers down after the preprogrammed treatment time (approximately 3 minutes).|Applies low level light to a herpes simplex virus cold sore on the lips. The light shortens the healing time of the cold sore.|Lips|N|N
SU|SU|OKO|Negative Pressure Wound Therapy Non-Powered Suction Apparatus|2||N|N||878.4680|1|A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials.|Mechanical pump and wound dressing kit|The wound bed is dressed, fitted with mode of communication between the wound bed and suction apparatus, and sealed (according to labeling instructions).  The suction apparatus is engaged to create a vacuum (negative pressure) within the wound bed drives the wound exudate to be pumped from the wound bed into a collection canister.  It is designed to provide a pre-set level of negative pressure to the wound bed.|For management of chronic, acute, traumatic, subacute and dehisced wounds; partial-thickness burns; ulcers (such as diabetic or pressure) flaps and grafts.|N|N
SU|SU|OLI|Fat Reducing Low Level Laser|2||N|N||878.5400|1|Non-invasive reduction in fat layer for body contouring|laser system that emits laser energy in the red spectrum|use of low level laser energy to create pores in adipocyte cells to release lipoproteins|adipocyte cells within the fat layer of the body, this could include wasit, thighs, abdomin, hips, etc...|N|N
SU|SU|OLP|Over-The-Counter Powered Light Based Laser For Acne|2||N|N||878.4810|1|The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris.  The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.|Light Source: LED|The outputs are pre-tuned to a particular wavelength with a narrow spectral bandwidth.|Mainly on the face, but can be on the back or on the other parts of the body. Treatment area is 5x6 cm (at a time.)|N|N
SU|SU|OMD|Cutaneous Tissue Adhesive With Mesh|2||N|N||878.4011|1|For topical application only to hold closed easily approximated skin edges of wounds such as wounds from surgical incisions, including punctures from minimally invasive surgery, and simple thorough cleansed, trauma-induced lacerations.  The device may be used in conjunction with, but not in place of, deep dermal sutures.|1) A liquid adhesive and  2) A self-adhering initiated mesh athat is packaged within an applicator|Adhesive to hold closed skin edges of wounds|The device is meant to act topically on the skin|N|N
SU|SU|OMP|Negative Pressure Wound Therapy Powered Suction Pump|2||N|N||878.4780|1|For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials.  The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.|Powered suction pump and wound dressing kit|The wound bed is dressed, fitted with mode of communication between the wound bed and suction apparatus, and sealed (according to labeling instructions). The suction apparatus is engaged to create a vacuum (negative pressure) within the wound bed drives the wound exudate to be pumped from the wound bed into a collection canister. The device is designed to provide a pre-set level of negative pressure to the wound bed.|For management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.|N|N
SU|SU|ONE|Powered Light Based Non-Laser Surgical Instrument|2||N|N||878.4810|1|A light based Non-Laser device typically indicated to be used for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. Indication for Use can be general and/or specific. The classification regulation 21 CFR 878.4810  describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate  tissue by the light.|The device comes in a wide verity of shapes and sizes. It could be hand held and with weight less than one pound or it could be heavy with weight more than fifty pounds. It generally has a base station with attachments such as different hand piece(s) and touch tone/display screen or other mechanical buttons for user interactions|This is a powered light based but non-laser instrument that uses light energy to destroy or coagulate tissue, generally soft tissue.|The device generally targets skin (including dermis, epidermis) and underlying soft tissue or soft tissue in general.|N|N
SU|SU|ONF|Powered Light Based Non-Laser Surgical Instrument With Thermal Effect|2||N|N||878.4810|1|A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic.  Indication for use can be general and/or specific.The classification regulation 21 cfr 878.4810  describes a device that is carbon dioxide or argon laser intended to cut, destroy, or remove tissue by the light.|The device comes in a wide verity of shapes and sizes. It could be hand held and with weight less than one pound or it could be heavy with weight more than fifty pounds. It generally has a base station with attachments such as different hand piece(s) and touch tone/display screen or other mechanical buttons for user interactions.|This is a light based Non-Laser device that provides thermal effect including broad spectrum source devices such as Intense Pulse Light (IPL) that uses light energy to cut, destroy, remove or coagulate tissue, generally soft tissue. The classification regulation 21 CFR 878.4810  describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.|The device generally targets skin (including dermis, epidermis) and underlying soft tissue or soft tissue in general.|N|N
SU|SU|ONG|Powered Laser Surgical Instrument With Microbeam\Fractional Output|2||N|N||878.4810|1|A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. The laser output is in form of tiny beams in micro range. Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic to destroy, remove or coagulate tissue, generally soft tissue.  Indication for Use can be general and/or specific. The classification regulation 21 CFR 878.4810  describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.|The device comes in a wide verity of shapes and sizes. It could be hand held and with weight less than one pound or it could be heavy with weight more than fifty pounds. It generally has a base station with attachments such as different hand piece(s) and touch tone/display screen or other mechanical buttons for user interactions.|A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. The laser output is in form of tiny beam(s) in micro range. The classification regulation 21 CFR 878.4810  describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.|The device generally targets skin (including dermis, epidermis) and underlying soft tissue or soft tissue in general.|N|N
SU|SU|ONQ|Electrosurgical Coagulation For Aesthetic|2||N|Y|M|878.4400|1|For the treatment of spider vein or telangiectasia by thermocoagulation.|Electrosurgical generator and needle electrodes|High Frequency radio wave energy|small surface blood vessels|N|N
SU|SU|OOD|Surgical Film|2||N|N||878.3300|1|To be implanted to reinforce soft tissue or bone where weakness exists. Intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.  The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.|absorbable solid form of poly(hydroxybutyrate)|material is isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) methods|soft tissue and bone|Y|Y
SU|SU|OOK|Dermal Cooling Pack/Vacuum/Massager|2||N|N||878.4340|1|The device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disrutpion or induction of adipocyte cells indicated for body contouring or reduction in circumferance of body areas.|the device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disrutpion or induction of adipocyte cells indicated for body contouring or reduction in circumferance of body areas.|release of fat and lipids from adipocyte cells resulting in reduction in fat layer|areasof the body for which a subject wishes to have reduction in size such as abdomen, thighs, waist, hips.|N|N
SU|SU|OPA|Powder-Free Non-Natural Rubber Latex Surgeon'S Gloves|1||N|N||878.4460|1|A powder-free surgeon's glove is a disposable device made of non-natural rubber that may bear a trace amount of residual powder and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.|A powder-free surgeon's glove is a disposable device made of non-natural rubber that may bear a trace amount of residual powder and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.|A powder-free surgeon's glove is a disposable device made of non-natural rubber that may bear a trace amount of residual powder and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.|glove|N|N
SU|SU|OPG|Powdered Non-Natural Rubber Latex Surgeon'S Gloves|1||N|N||878.4460|1|A powdered surgeon's glove is a disposable device made of non-natural rubber that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.|A powdered surgeon's glove is a disposable device made of non-natural rubber that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.|A powdered surgeon's glove is a disposable device made of non-natural rubber that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.|glove|N|N
SU|SU|OQL|Mesh, Surgical, Deployment Balloon|2||N|N||878.3300|1|The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias.|The device is comprised of three main components: an inflatable spreading balloon, an adaptor, and an inflation unit/pump.|The device is reversibly attached to soft tissue prosthetics, such as surgical mesh, through the use of connectors, before being rolled for insertion into the body. Once located in the abdominal cavity, the device is spread at the desired location by inflating it using an external inflation pump.|Abdominal cavity.|N|N
SU|SU|ORE|Cryogenic, Skin Tag Removal, Otc|2||N|N||878.4350|1|removal of skin tags|by thermal cooling|apply crogenic device|skin tags in visible areas|N|N
SU|SU|ORK|Laser Assisted Lipolysis|2||N|N||878.4810|1|Intended to be used for laser assisted lipolysis|The device is a laser module.|Laser Assisted Lipolysis is a procedure that uses laser energy to melt small volume of fat. The fat is then removed from the body by aspiration.|A small volume (up to 120cc) of localized deposits of fat per treatment such as chin or upper arm (triceps)|N|N
SU|SU|ORQ|Mesh, Surgical, Deployer|2||N|N||878.3300|1|Intended to be used to facilitate the delivery of soft tissue prosthetics during the  laparoscopic repair of soft tissue defects (e.G. Hernia repair).|manual laparoscopic surgical instrument ;operation handle and deployment section.|intended to facilitate hernia mesh delivery and placement during laparoscopic ventral hernia repair.|abdominal cavity|N|N
SU|SU|OTK|Wound Drain Catheter System|2||N|N||878.4780|1|For use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound.  The device is indicated for use in thoracic surgical procedures.|The system comprise of a silicone drainge tube, guide tube with integrated magnetic shuttle assembly.|The system employs a magnetic clearance mechanism integrated into the drainage tubing to allow the user to clear materials which may accumulate inside the drainage tube.|For use in chest areas following thoracic surgical procedures.|N|N
SU|SU|OUB|Instrument For Treatment Of Hyperhidrosis|2||N|N||878.4400|1|Soft-tissue coagulation|The System consists of the following components: the Console; the Handpiece; and a disposable tip that snaps onto the Handpiece.|microwave based system|dermal-hypodermal interface|N|N
SU|SU|OUH|Skin Resurfacing Rf Applicator|2||N|N||878.4400|1|Skin resurfacing|Hand held device with a range of electrodes (64-144) that penetrate the top layer of the skin and then generates RF pulses to create micro-ablative points.|Applicator emits RF energy that flows between electrodes to create micro-ablative points on the skin, forming superficial ablation with a volumetric non ablative heating effect in the dermis.|dermatologic use|N|N
SU|SU|OUP|Powered Surgical Instrument For Improvement In The Appearance Of Cellulite|2||N|N||878.4790|1|Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite.|The device consists of a cutting blade powered by a motor and a means for instrument guidance to control the areas of subcutaneous tissue cutting underneath the cellulite depressions or dimples.|The device temporarily improves the appearance of cellulite by controlled release (cutting) of the subcutaneous tissue underneath the cellulite depressions or dimples.|Area with Cellulite, Fibrous Septae, Fat, Soft Tissue.|N|N
SU|SU|OVN|Suture Kit|2||N|N||878.4830|7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
SU|SU|OWR|Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists in facial plastic surgery.|A plastic polymer mesh; either square, rectangular, or round.|A non-absorbable mesh that reinforces soft tissue.|Face|Y|N
SU|SU|OWS|Mesh, Surgical, Collagen, Plastics, Facial Implants|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists in facial plastic surgery.|A collagen mesh; either square, rectangular, round, or of other various shapes.|A collagen mesh that reinforces soft tissue.|Face|Y|N
SU|SU|OWT|Mesh, Surgical, Absorbable, Abdominal Hernia|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists during hernia repair.|An absorbable mesh; either square, rectangular, round or of various other shapes.|An absorbable mesh that reinforces soft tissue|Including but not limited to abdominal, inguinal, femoral, umbilical, and incisional hernias.|Y|N
SU|SU|OWU|Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair.|A non-absorbable mesh; either square, round, rectangular or of various other shapes.|A non-absorbable mesh that reinforces soft tissue.|Diaphragm|Y|N
SU|SU|OWV|Mesh, Surgical, Collagen, Diaphragmatic Hernia|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair.|A collagen mesh; either square, round, rectangular or of various other shapes.|A collagen mesh that reinforces soft tissue.|Diaphragm|Y|N
SU|SU|OWW|Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists during tendon repair procedures.|An absorbable mesh; either square, rectangular, round or of other various shapes|An absorbable mesh that reinforces soft tissue|Tendon|Y|N
SU|SU|OWX|Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists in tendon repair.|A non-absorbable mesh; either square, rectangular, round or of other various shapes.|A non-absorbable mesh that reinforces soft tissue.|Tendon|Y|N
SU|SU|OWY|Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists in tendon repair.|A collagen mesh; either square, rectangular, round or of various other shapes.|A collagen mesh that reinforces soft tissue.|Tendon|Y|N
SU|SU|OWZ|Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists during chest wall reconstruction.|An absorbable mesh; either square, rectangular, round or of various other shapes.|An absorbable mesh that reinforces soft tissue|Chest wall|Y|N
SU|SU|OXA|Mesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists during chest wall reconstruction.|A non-absorbable mesh; either square, rectangular, round or of various other shapes.|A non-absorbable mesh that reinforces soft tissue|Chest wall|Y|N
SU|SU|OXB|Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists during chest wall reconstruction.|A collagen mesh; either square, rectangular, round or of various other shapes.|A collagen mesh that reinforces soft tissue|Chest wall|Y|N
SU|SU|OXC|Mesh, Surgical, Absorbable, Staple Line Reinforcement|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.|An absorbable mesh; either square, rectangular, round or of various other shapes.|An absorbable mesh that reinforces soft tissue|Areas in need of sutures|Y|N
SU|SU|OXD|Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.|A non-absorbable mesh; either square, rectangular, round or of various other shapes.|A non-absorbable mesh that reinforces soft tissue|Areas in need of sutures|Y|N
SU|SU|OXE|Mesh, Surgical, Collagen, Staple Line Reinforcement|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.|A collagen mesh; either square, rectangular, round or of various other shapes|A collagen mesh that reinforces soft tissue|Areas in need of sutures|Y|N
SU|SU|OXF|Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.|An absorbable mesh; either square, round, rectangular or of various other shapes.|An absorbable mesh that reinforces soft tissue|An area in need of plastic and reconstructive surgery|Y|N
SU|SU|OXG|Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.|A plastic polymer mesh; either square, round, rectangular or of various other shapes.|A non-absorbable mesh that reinforces soft tissue|Areas in need of plastic and reconstructive surgery|Y|N
SU|SU|OXH|Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.|A collagen mesh; either square, rectangular, round or of various other shapes.|A collagen mesh that reinforces soft tissue|Areas in need of plastic and reconstructive surgery|Y|N
SU|SU|OXI|Mesh, Surgical, Absorbable, Large Abdominal Wall Defects|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists in abdominal wall defects.|An absorbable mesh; either square, rectangular, round or of various other shapes.|An absorbable mesh that reinforces soft tissue|Abdominal wall|Y|N
SU|SU|OXJ|Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists in abdominal wall defects.|A non-absorbable mesh; either square, round, rectangular or of various other shapes|A non-absorbable mesh that reinforces soft tissue|Abdominal wall|Y|N
SU|SU|OXK|Mesh, Surgical, Collagen, Large Abdominal Wall Defects|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists in abdominal wall defects.|A collagen mesh; either square, rectangular, round or of various other shapes|A collagen mesh that reinforces soft tissue|Abdominal wall|Y|N
SU|SU|OXL|Mesh, Surgical, Absorbable, Organ Support|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists during organ support.|An absorbable mesh; either square, rectangular, round or of various other shapes|An absorbable mesh that reinforces soft tissue|Various organs in need of temporary support|Y|N
SU|SU|OXM|Mesh, Surgical, Absorbable, Fistula|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists during the repair of fistulas.|An absorbable mesh; round, rectangular, square or of various other shapes|An absorbable mesh for the reinforcement of soft tissue.|Anorectal, enterocutaneous, and recto-vaginal fistulas|Y|N
SU|SU|OXN|Mesh, Surgical, Collagen, Fistula|2||N|N||878.3300|1|For reinforcement of soft tissue where weakness exists during the repair of fistulas.|A collagen mesh; square, rectangular, round or of other various shapes|A collagen mesh for the reinforcement of soft tissue|Anorectal, enterocutaneous, and recto-vaginal fistulas|Y|N
SU|SU|OXT|Percutaneous Surgical Set With Attachments|2||N|N||878.4805|1|Minimally invasive devices with the means to penetrate soft tissue to access the abdomen.  The attachment and the shaft will be assembled and disassembled within the abdomen before and after use. The devices are used to grasp, hold, and manipulate soft tissues.|A shaft plus end effector attachments with different sizes|A shaft of the device that can penetrate through soft tissue; attachments that will be delivered through a traditional conduit (such as a trocar) and assembled with the shaft inside the abdomen.|abdominal region|N|N
SU|SU|OYW|Laser, Cellulite Appearance|2||N|N||878.4810|1|For the removal of fat through laser lipolysis.|Laser system using fiber optic delivery system to deliver the laser energy to the site through a cannula|delivery of laser energy via a cannula into the subdermal area to dissolove fat and disrupt the septae that affect the appearance of cellulite|area that have cellulite issues|N|N
SU|SU|PBD|Composite Cultured Skin|f||N|N||878.4024|6|For patients with mitten hand deformities due to Recessive Dystrophic Epidermolysis Bullosa (RDEB)|Composite Cultured Skin (CCS) is an aseptically processed wound dressing composed of a bovine collagen matrix (coated sponge) in which normal human allogeneic skin cells (epidermal keratinocytes and dermal fibroblasts) are cultured in two layers.   The device measures approximately 6 cm x 6 cm (minimally 36 cm2).|Device fucntions as a phsycia l cover of a autograft wound site.  It provdies a mosit wound healign environment and physiological components that interact with the acute wound.|Wounds created during surgical release of hand contractures (i.e., "mitten" hand deformities).|Y|N
SU|SU|PBX|Massager, Vacuum, Radio Frequency Induced Heat|2||N|N||878.4400|1|Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.|A console that generates the RF energy. It has two handpieces, an RF handpiece to apply energy for the pain relief indication and a mechanical roller handpiece for the cellulite indication.|Increases the temperature of skin by deposition of RF waves to relieve minor aches and pain. It  uses a mechanical roller to reduce the appearance of cellulite.|Skin.|N|N
SU|SU|PBY|Temporary Tissue Marker|2||N|N||878.4300|1|To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue.|May include: implantable marker, delivery device|Marks a tissue location by being visible using imaging techniques.|Tissue intended to be removed surgically|N|N
SU|SU|PDG|Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.|2||N|N||878.4400|1|Intended for any procedure where vessel ligation (cutting and sealing), soft tissue grasping and dissection are performed.|Applicator/Dissector, RF Generator and Battery are integrated in a single handpiece.|Application of RF energy to heat and seal vessel/tissue followed by dissection of target vessel/tissue.|Has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures.|N|N
SU|SU|PDW|Internal Tissue Marker|2||N|N||878.4670|1|An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.|Marker with dye.|A biocompatible dye that is applied to the target tissue using a soft tipped marker.|Organs, veins, arteries and other internal tissues.|N|N
SU|SU|PDZ|Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis|2||N|N||878.4810|1|For the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).|Laser device outputting energy at different wavelengths|Laser energy delivered to the target area by scanning|Toe nail of the patients with onychomycosis|N|N
SU|SU|PFP|Silicone Hydrogel For Scar Management|1||N|N||878.4025|1|Management of closed hyperproliferative (hypertrophic and keloid) scars.|Silicone oil containing hydrogel with preservative identified by the Center for Drug Evaluation and Research (CDER) as an inactive ingredient.|Product forms a protective film that helps maintain skin hydration.|Scars on the skin|N|N
SU|SU|PGZ|Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use|2||N|N||878.4452|1|To control bleeding in junctional, non-compressible wounds until surgical care is acquired.|Sterile, non-absorbable, radiopaque, expandable sponges that may include a delivery device.|The sponges expand upon contact with blood to fill the wound cavity and provide pressure and a physical barrier that facilitates formation of a clot. The temporary sponges are completely removed from the wound during surgery prior to closure.|Junctional, non-compressible wounds in the groin or axilla not amenable to tourniquet application. It is NOT indicated for use in the following areas: thorax; pleural cavity; mediastinum; abdomen; retroperitoneal space; sacral space above the inguinal ligament; or tissues above the clavicle.|N|N
SU|SU|PIJ|Collagen Surgical Mesh Containing Drugs |2||N|N||878.3300|1|Reinforcement of soft tissue where weakness exists.|An acellular, sterile, non-pyrogenic porcine dermal matrix . The graft is packed dry and must be hydrated in sterile saline prior to use. The thickness of the device is 1.5 to 2.3mm.     The device surfaces are coated with an antimicrobial coating, which is comprised of a bioresorbable L-tyrosine succinate polymer and antimicrobial agents Rifampin and Minocycline at 180 µg/cm2 each.|Used to reinforce soft tissue defects, e.g., hernias, etc...|soft tissues|Y|N
SU|SU|PJK|Tissue Adhesive For Internal Use|3||N|N||878.4010|2|Approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty.|A surgical adhesive based on a polyurethane pre-polymer. In its pre-polymerized form, this is a viscous liquid. The primary component of the adhesive is created by reacting trimethylolpropane (TMP) with lysine di-isocyanate ethyl ester (LDI).|The liquid is applied drop-wise to the tissue surfaces to be adhered, and then the tissue surfaces are approximated for several minutes to allow the moisture in the tissue to initiate the curing process.  The applicator is a hand-held, disposable device that stores 5 ml of adhesive for delivery in drops onto planar surfaces of tissue.   When exposure to water, the product reacts with amine and hydroxyl groups on biological tissue and with itself to produce a polymerized network.|Abdominoplasty tissue flaps|Y|N
SU|SU|PKO|Transparent Patch For Use In Treatment Of Tattoos|2||N|N||878.4810|1|To reduce formation of bubbles during laser treatment of tattoos.|Liquid in a transparent double sided silicon patch|Uses a chemical optical clearing agent to interact with the bubbles as they are attempting to form to prevent this formation.|tattoos|N|N
SU|SU|PKT|Laser For Disruption Of Adipocyte Cells For Aesthetic Use|2||Y|N||878.5400|1|Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.|The device may include up to three rectangular applicator heads with sapphire glass and dimensions of 4 cm x 6 cm. The laser may be 1064 nm and range in power density from 0.9-1.4 W/cm2.|Laser energy is delivered to the adipose tissue to elevate temperature to 42-47 C for disruption of adipocyte cells. Subsequently, the adipocyte cells release fat and lipids resulting in reduction of the adipose tissue.|Areas of the body for treatment such as the flank, abdomen, thighs, waist, hips|N|N
SU|SU|REF|Suntan Bed|2||N|N||878.4635|1|A bed or other platform that is designed to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the human body, by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning.||||N|N
SU|SU|REG|Suntan Lamp|2||N|N||878.4635|1|A lamp that produces ultraviolet radiation in the wavelength range of 200 to 400 nanometers in air and that is intended for use in any sunlamp product or fixture.||||N|N
SU|SU|REH|Tabletop Sunlamp System|2||N|N||878.4635|1|A sunlamp system that sits on a table, primarily intended to tan the face by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers.||||N|N
SU||DTH|Suture, Cardiovascular|3||N|N|||2|||||Y|N
SU||DZG|Suture, Dental|3||N|N|||2|||||Y|N
SU||EFQ|Gauze/Sponge, Internal|U|1|N|N|||1|||||N|N
SU||EPW|Support, Head, Surgical, Ent|U|1|N|N|||1|||||N|N
SU||EYF|Protector, Wound, Plastic|U|1|N|N|||1|||||N|N
SU||FPX|Strip, Adhesive, Closure, Skin|U|1|N|N|||1|||||N|N
SU||FRO|Dressing, Wound, Drug|U|1|N|N|||1|||||N|N
SU||GAO|Suture, Nonabsorbable|U|1|N|N|||1|||||Y|N
SU||GEL|Gauze/Sponge, Internal, With Drug/Biologic, Animal Source Material|U|1|N|N|||1|||||N|N
SU||GER|Gauze, External (With Drug/Biologic/Animal Source Material)|U|1|N|N|||1|||||N|N
SU||HMN|Suture, Nonabsorable, Ophthalmic|3||N|N|||2|||||Y|N
SU||HMO|Suture, Absorbable, Ophthalmic|3||N|N|||2|||||Y|N
SU||KGM|Silicone, Liquid, Injectable|3||N|N|||2|||||N|N
SU||KGN|Dressing, Wound, Collagen|U|1|N|N|||1|||||N|N
SU||LCJ|Expander, Skin, Inflatable|U|1|N|N|||1|||||Y|N
SU||LFL|Instrument, Ultrasonic Surgical|U|1|N|N|||1|||||N|N
SU||LMH|Implant, Dermal, For Aesthetic Use|3||N|N|||2|||||Y|N
SU||LMI|Implant, Collagen For Non-Aesthetic Use|3||N|N|||2|||||Y|N
SU||LRQ|Kit, Tracheostomy And Nasal Suctioning|N|6|N|N|||7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
SU||LRR|First Aid Kit With Drug|N|6|N|N|||7|Note:  In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well.  www.fda.gov/cder/index.html - This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|Note:  In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well.  www.fda.gov/cder/index.html - This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|Note:  In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well.  www.fda.gov/cder/index.html - This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|Note:  In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well.  www.fda.gov/cder/index.html - This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
SU||LRS|Kit, I.V. Start|N|6|N|N|||7|||||N|N
SU||LXZ|Guard, Instrument|U|1|N|N|||1|||||N|N
SU||LZK|Implant, Malar|U|1|N|N|||1|||||Y|N
SU||LZM|Guard, Skin Graft|U|1|N|N|||1|||||N|N
SU||MAC|Kit, Decontamination|N|6|N|N|||7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
SU||MAW|Marker, Suture Identification|U|1|N|N|||1|||||N|N
SU||MCA|Tape, Surgical, Internal|U|1|N|N|||1|||||Y|N
SU||MCZ|Suture Removal Kit|N|6|N|N|||7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
SU||MDD|Device, Dermal Replacement|3||N|N|||2|||||Y|N
SU||MGO|Closure, Wound, Adhesive|U|1|N|N|||1|||||N|N
SU||MGP|Dressing, Wound And Burn, Occlusive|U|1|N|N|||1|||||N|N
SU||MGQ|Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic|U|1|N|N|||1|||||N|N
SU||MGR|Dressing, Wound And Burn, Interactive|3||N|N|||2|||||N|N
SU||MIC|Implant, Muscle, Pectoralis|U|1|N|N|||1|||||Y|N
SU||MIW|Clothing, Protective, Sun|U|1|N|N|||1|||||N|N
SU||MQZ|Prosthesis, Nail|U|1|N|N|||1|||||N|N
SU||MRD|Sizer, Mammary, Breast Implant Volume|U|1|N|N|||1|||||N|N
SU||MSA|Dressing,Wound And Burn,Occlusive,Heated|U|1|N|N|||1|||||N|N
SU||MTJ|Wax,Bone|U|1|N|N|||1|||||Y|N
SU||MVF|System, Laser, Photodynamic Therapy|3||N|N|||2|||||N|N
SU||MVG|System, Laser, Fiber Optic, Photodynamic Therapy|3||N|N|||2|||||N|N
SU||MWY|System,Microwave,Hair Removal|U|1|N|N|||1|||||N|N
SU||MWZ|Expander,Breast,External|U|1|N|N|||1|||||N|N
SU||MXE|Tape And Bandage,Adhesive(With Disinfectant)|U|1|N|N|||1|||||N|N
SU||MXG|Lamp,Uvc,(For Treating Skin And Wounds)|U|1|N|N|||1|||||N|N
SU||MYH|System,Non-Coherent Light,Photodynamic Therapy|3||N|N|||2|||||N|N
SU||NBE|Sealant,Polymerizing|3||N|N|||2|||||Y|N
SU||NLQ|Scalpel, Ultrasonic, Reprocessed|U|1|N|N|||1|The ultrasonic scalpel is intended for incision and excision of soft tissues.  This device is indicated for reuse/reprocessing.||||N|N
SU||NQK|Maggots, Medical|U|1|N|N|||1|Phaenicia sericacta (blow fly) larvae are harvested and provided disinfected for use in debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post surgical wounds.||||N|N
SU||NRN|Leeches, Medicinal|U|1|N|N|||1|The device is a medicinal leech (hirudo medicinalis) belonging to the annelida worm classification.  The animal is a bloodsucking aquatic animal living in fresh water.  The device should be indicated as: "an adjunct to the graft tissue healing when problems of venous congestion may delay healing, or to overcome the problem of venous congestion by creating prolonged localized bleeding."||||N|N
SU||NSS|Electronic Media, Nausea|N|6|N|N|||7|Treatment of nausea and vomiting associated with morning sickness and motion sickness.||||N|N
SU||OAZ|One-Way Air-Leak Valve|f||N|N|||6|To restrict air flow to the target section of the lung.  To control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (lvrs). An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise.|This device is a small nitinol frame that has a polyurethane membrane over the Nitinol frame that acts as a plug to the targeted section of the lung.|The device is a nitonal frame with a polyurethane membrane over the Nitinol frame. The valve does not allow air into the targeted segment of the lung, but does allow air and mucus out of that lung section.|The device is intended to occlude a section of lung.|Y|N
SU||OCE|Cultured Epithelial Autograft|f||N|N|||6|Interactive wound and burn dressing containing a live xenogeneic component.  Indicated for use in patients who have deep dermal or full thickness burns comprising a total body surface area of greater than or equal to 30%.  It may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.|Epicel cultured epidermal autografts (CEA) is an aseptically processed wound dressing composed of the patient?s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts.  Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft.  Each graft of Epicel is attached to petrolatum gauze backing with stainless steel surgical clips and measures approximately 50 cm2 in area.|Patient's own cells are in vitro cultivated and expanded in number into a graft/dressing design in sufficient size to facilitate coverage of the burn injury.|Entire integumentary (skin) system|Y|Y
SU||ODS|Orcel-Composite Cultured Skin|f||N|N|||6|Wound covering.  Indicated for use in patients with mitten hand deformities due to recessive dystrophic epidermolysis bullosa (rdeb) as an adjunct to standard autograft procedures (i.E., skin grafts and flaps) for covering wounds and donor sites created after the surgical release of hand contractures (i.E., ?mitten? hand deformities).|Solid|Cellular Wound Dressing|Extremities|Y|N
SU||OEE|Diagnostic Low Electric Field|3||N|N|||2|As an adjunctive tool to guide the shavings of tissue at the margins of the tumor for use in excisional breast surgery to assist in locating the tissue for excision. In addition to other standard methods such as intraoperative imaging and palpation.|low electromagnetic field|It utilizes electromagnetic waves to characterize human tissue in real-time. It consists of a console and a disposable hand-piece.|breast tumor|N|N
SU||OJI|Burn Kit With Drug|N|6|N|N|||7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
SU||OJJ|Burn Kit Without Drug|N|6|N|N|||7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.|N|N
SU||OXQ|Dressing Change Tray|N|6|N|N|||7|This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
SU||OYD|Optical Diagnostic Device For Melanoma Detection|3||N|N|||2|Intended in the detection of melanoma and high grade lesions among atypical lesions in order to rule-out melanoma.|Optical radiation.|Use of visible and infrared optical radiation to generate images of targeted atypical lesions.|Atypical pigmented lesions|N|N
SU||PFC|Cultured Human Cell Skin Dressing|3||N|N|||2|Allogeneic skin cells cultured in vitro and combined with scaffold sheeting to act as a physical wound covering and provide biological components that interact with the wound, for treatment of skin ulcers.|Allogeneic skin cells are cultured in vitro and combined with scaffold sheeting|Device funtions as a physical wound covering and provides biological components that interact with the wound|Skin|Y|N
SU||PHU|Intra-Abdominal Pressure Monitoring Device|U|1|N|N|||1|Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure.|Urological catheter, pressure sensing device.|Monitoring abdominal intracompartmental pressure with a urological catheter|Urological|Y|N
SU||PKD|Laceration Tray|N|6|N|N|||7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm.   This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm.   This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm.   This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm.   This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
SU||PKE|Laparoscopic Cholecystectomy Kit|N|6|N|N|||7|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm .  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm .  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm .  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm .  This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.|N|N
SU||PKY|Implant, Dermal, For Aesthetic Use In The Hands|3||N|N|||2|For hand augmentation to correct volume loss in the dorsum of the hands.|Injectable mixture in a syringe with a needle.|To provide volume fullness to the dorsum (back) of the hand|Dorsum (back) of the hand|Y|N
TX|CH|DII|Columns, Glc|1||N|N||862.2250|4|||||N|N
TX|CH|DJA|Column Supports, Glc|1||N|N||862.2250|4|||||N|N
TX|CH|DJO|Indicator, Cellulose Fluorescent, Tlc|1||N|N||862.2270|4|||||N|N
TX|CH|DJS|U.V. Light, Tlc|1||Y|N||862.2270|4|||||N|N
TX|CH|DJY|Ion-Exchange Chromatography|1||N|N||862.2230|4|||||N|N
TX|CH|DKG|Plate, Cellulose, Tlc|1||N|N||862.2270|4|||||N|N
TX|CH|DKK|Tanks, Developing, Tlc|1||Y|N||862.2270|4|||||N|N
TX|CH|DKO|Adsorbents, Ion-Exchange|1||N|N||862.2230|4|||||N|N
TX|CH|DKS|Plate, Silica Gel, Tlc|1||N|N||862.2270|4|||||N|N
TX|CH|DKY|Indicator, Alumina Fluorescent, Tlc|1||N|N||862.2270|4|||||N|N
TX|CH|DLC|Atomizer, Tlc|1||Y|N||862.2270|4|||||N|N
TX|CH|DLG|Coating, Liquid, Glc|1||N|N||862.2250|4|||||N|N
TX|CH|DLO|Indicator, Silica Gel Fluorescent, Tlc|1||N|N||862.2270|4|||||N|N
TX|CH|DLY|Plate, Alumina, Tlc|1||N|N||862.2270|4|||||N|N
TX|CH|DMG|Papers, Ion|1||N|N||862.2230|4|||||N|N
TX|CH|DMS|Gases, Glc|1||N|N||862.2250|4|||||N|N
TX|CH|DMZ|Liquid Chromatography, Adsorbent|1||N|N||862.2260|4|||||N|N
TX|CH|DNH|Resins, Ion-Exchange, Liquid Chromatography|1||N|N||862.2260|4|||||N|N
TX|CH|DOP|Mass Spectrometer, Clinical Use|1||N|N||862.2860|4|||||N|N
TX|CH|DPA|Apparatus, General Use, Thin Layer Chromatography|1||Y|N||862.2270|4|||||N|N
TX|CH|DPM|Columns, Liquid Chromatography|1||N|N||862.2260|4|||||N|N
TX|CH|JSQ|Chromatography For Bacterial Identification|1||N|N||862.2250|4|||||N|N
TX|CH|JXQ|Monitor, U.V., Glc|1||N|P||862.2250|4|||||N|N
TX|CH|JXR|Atomic Absorption Spectrophotometer, General Use|1||N|N||862.2850|4|||||N|N
TX|CH|KEA|Resins, Ion-Exchange|1||N|N||862.2230|4|||||N|N
TX|CH|KIE|Apparatus, High Pressure Liquid Chromatography|1||N|N||862.2260|4|||||N|N
TX|CH|KZQ|Chromatography(Gas), Clinical Use|1||N|N||862.2250|4|||||N|N
TX|CH|KZR|Chromatography (Liquid, Gel), Clinical Use|1||N|N||862.2260|4|||||N|N
TX|CH|KZS|Chromatography (Thin Layer), Clinical Use|1||N|N||862.2270|4|||||N|N
TX|CH|LDM|Instrumentation, High Pressure Liquid Chromatography|1||N|N||862.2260|4|||||N|N
TX|CH|LEQ|Detectors, Electrochemical, Liquid Chromatography|1||N|N||862.2260|4|||||N|N
TX|CH|LTB|Cyclosporine Radioimmunoassay|2||N|N||862.1235|1|||||N|N
TX|CH|MAR|Cyclosporine And Metabolites Serum Assay|2||N|N||862.1235|1|||||N|N
TX|CH|MGS|High Performance Liquid Chromatography For Cyclosporine|2||N|N||862.1235|1|||||N|N
TX|CH|MGU|Fluroesence Polorization Immunoassay For Cyclosporine|2||N|N||862.1235|1|||||N|N
TX|CH|MGV|Radioimmunoassay For Cyclosporine|2||N|N||862.1235|1|||||N|N
TX|CH|MKW|Cyclosporine|2||N|N||862.1235|1|||||N|N
TX|CH|MLM|Enzyme Immunoassay, Tracrolimus|2||N|N||862.1678|1|||||N|N
TX|CH|NFX|Test, Cholesterol, Total, Over The Counter|1||N|N||862.1175|1|||||N|N
TX|CH|NFZ|Test, Creatinine, Over The Counter|2||N|N||862.1225|1|||||N|N
TX|CH|NGA|Test, Follicle Stimulating Hormone (Fsh), Over The Counter|1||N|N||862.1300|4|||||N|N
TX|CH|NGD|Test, Lactic Acid, Over The Counter|1||N|N||862.1450|1|||||N|N
TX|CH|NGE|Test, Luteinizing Hormone (Lh), Over The Counter|1||N|N||862.1485|4|||||N|N
TX|CH|NGJ|Test, Nitrite, Urinary, Non-Quantitative, Over The Counter|1||N|N||862.1510|1|||||N|N
TX|CH|NGO|Test, Triglycerides, Over The Counter|1||N|N||862.1705|1|||||N|N
TX|CH|PFT|Reagents For Molecular Diagnostic Test Systems|1||N|N||862.3800|4|Non-analyte-specific reagents used as part of molecular diagnostic test systems, such as polymerases, nucleotides and nucleotide mixes, master mixes in which individual reagents are optimized to be used together.|Individual reagents or reagent packages|Not applicable|Not applicable|N|N
TX|HE|NGB|Test, Glycosylated Hemoglobin, Over The Counter|2||N|N||864.7470|1|||||N|N
TX|HE|NGK|Test, Occult Blood, Over The Counter|2||N|N||864.6550|1|||||N|N
TX|IM|NTV|Myeloperoxidase, Immunoassay, System, Test|2||N|N||866.5600|1|MYELOPEROXIDASE, IMMUNOASSAY, SYSTEM, TEST IS INTENDED TO MEASURE MYELOPEROXIDASE IN HUMAN PLASMA, TO BE USED IN CONJUNCTION WITH CLINICAL HISTORY, ECG AND CARDIAC BIOMARKERS TO EVALUATE PATIENTS PRESENTING WITH CHEST PAIN THAT ARE AT RISK FOR MAJOR ADVERSE CARDIAC EVENTS, INCLUDING MYOCARDIAL INFARCTION, NEED FOR REVASCULARIZATION, OR DEATH.||||N|N
TX|IM|PFF|High Throughput Dna Sequence Analyzer|2||N|N||862.2265|4|A high throughput sequencing technology performing targeted DNA sequencing of amplicons from a defined genetic region or a subset of genes in human genomic DNA from a clinical sample.|sequencing instrument and associated software|A high throughput DNA sequence analyzer is an automated clinical multiplex instrument system intended to prepare, generate, measure and sort signals in order to analyze DNA molecules of amplicons from a clinical sample such as peripheral whole blood.  Signals produced are measured and interpreted by accompanying software into DNA sequence information.|human genomic DNA from a clinical sample|N|N
TX|TX|DIC|Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method|2||N|P||862.3040|1|||||N|N
TX|TX|DID|Bacillus Subtlis Microbiology Assay, Tobramycin|2||N|P||862.3900|1|||||N|N
TX|TX|DIE|Heavy Metals Control Materials|1||N|Y||862.3280|1|||||N|N
TX|TX|DIF|Drug Mixture Control Materials|1||N|Y||862.3280|1|||||N|N
TX|TX|DIG|Cholinesterase Test Paper|1||N|Y||862.3240|7|||||N|N
TX|TX|DIH|Colorimetry, Cholinesterase|1||N|Y||862.3240|7|||||N|N
TX|TX|DIJ|Lead, Delta Amino Levulinic Acid|2||N|P||862.3550|1|||||N|N
TX|TX|DIK|Thin Layer Chromatography, Quinine|1||N|Y||862.3750|1|||||N|N
TX|TX|DIL|Radioimmunoassay, Primidone|2||N|P||862.3680|1|||||N|N
TX|TX|DIM|Gas Chromatography, Salicylate|2||N|P||862.3830|1|||||N|N
TX|TX|DIN|Gas Chromatography, Cocaine|2||N|Y||862.3250|1|||||N|N
TX|TX|DIO|Enzyme Immunoassay, Cocaine And Cocaine Metabolites|2||N|Y||862.3250|1|||||N|N
TX|TX|DIP|Enzyme Immunoassay, Diphenylhydantoin|2||N|P||862.3350|1|||||N|N
TX|TX|DIQ|Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep.|2||N|Y||862.3640|1|||||N|N
TX|TX|DIR|Free Radical Assay, Cocaine|2||N|Y||862.3250|1|||||N|N
TX|TX|DIS|Enzyme Immunoassay, Barbiturate|2||N|P||862.3150|1|||||N|N
TX|TX|DIT|Thin Layer Chromatography, Amphetamine|2||N|Y||862.3100|1|||||N|N
TX|TX|DIW|Hemagglutination Inhibition, Methadone|2||N|Y||862.3620|1|||||N|N
TX|TX|DIX|Thin Layer Chromatography, Phenobarbital|2||N|P||862.3660|1|||||N|N
TX|TX|DIY|Gas Chromatography, Ethosuximide|2||N|P||862.3380|1|||||N|N
TX|TX|DIZ|Delayed Analysis, Alcohol|2||N|P||862.3040|1|||||N|N
TX|TX|DJB|Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.|2||N|P||862.3450|1|||||N|N
TX|TX|DJC|Thin Layer Chromatography, Metamphetamine|2||N|Y||862.3610|1|||||N|N
TX|TX|DJD|Enzyme Immunoassay, Primidone|2||N|P||862.3680|1|||||N|N
TX|TX|DJE|Thin Layer Chromatography, Salicylate|2||N|P||862.3830|1|||||N|N
TX|TX|DJF|Gas Chromatography, Opiates|2||N|Y||862.3650|1|||||N|N
TX|TX|DJG|Enzyme Immunoassay, Opiates|2||N|Y||862.3650|1|||||N|N
TX|TX|DJH|Gas Chromatography, Phenobarbital|2||N|P||862.3660|1|||||N|N
TX|TX|DJI|Antiserum, Gentamicin|2||N|P||862.3450|1|||||N|N
TX|TX|DJJ|Fluorometry, Morphine|2||N|Y||862.3640|1|||||N|N
TX|TX|DJK|Digitoxin Control Serum, Ria|1||N|Y||862.3280|1|||||N|N
TX|TX|DJL|Free Radical Assay, Amphetamine|2||N|Y||862.3100|1|||||N|N
TX|TX|DJN|Mercury Dithiazone, Colorimetry, Barbiturate|2||N|P||862.3150|1|||||N|N
TX|TX|DJP|Radioimmunoassay, Amphetamine|2||N|Y||862.3100|1|||||N|N
TX|TX|DJQ|Test Reagents For Phenothiazine|2||N|P||862.3670|1|||||N|N
TX|TX|DJR|Enzyme Immunoassay, Methadone|2||N|Y||862.3620|1|||||N|N
TX|TX|DJX|Radioimmunoassay, Ethosuximide|2||N|P||862.3380|1|||||N|N
TX|TX|DJZ|Devices, Breath Trapping, Alcohol|1||N|Y||862.3050|7|||||N|N
TX|TX|DKA|Antiserum, Digoxin|2||N|P||862.3320|1|||||N|N
TX|TX|DKB|Calibrators, Drug Mixture|2||N|Y||862.3200|1|||||N|N
TX|TX|DKC|Alcohol Control Materials|1||N|Y||862.3280|1|||||N|N
TX|TX|DKD|Bacillus Subtlis, Microbiological Assay, Gentamicin|2||N|P||862.3450|1|||||N|N
TX|TX|DKE|Reagents, Test, Tetrahydrocannabinol|2||N|Y||862.3870|1|||||N|N
TX|TX|DKH|Gas Chromatography, Diphenylhydantoin|2||N|P||862.3350|1|||||N|N
TX|TX|DKJ|Colorimetry, Salicylate|2||N|P||862.3830|1|||||N|N
TX|TX|DKN|Radioimmunoassay, Barbiturate|2||N|P||862.3150|1|||||N|N
TX|TX|DKP|Radioimmunoassay, Phenobarbital|2||N|P||862.3660|1|||||N|N
TX|TX|DKQ|Antiserum, Digitoxin|2||N|P||862.3300|1|||||N|N
TX|TX|DKR|Thin Layer Chromatography, Methadone|2||N|Y||862.3620|1|||||N|N
TX|TX|DKT|Free Radical Assay, Opiates|2||N|Y||862.3650|1|||||N|N
TX|TX|DKW|Test Reagents For Sulphanimide Derivatives|1||N|Y||862.3850|1|||||N|N
TX|TX|DKX|Thin Layer Chromatography, Barbiturate|2||N|P||862.3150|1|||||N|N
TX|TX|DKZ|Enzyme Immunoassay, Amphetamine|2||N|Y||862.3100|1|||||N|N
TX|TX|DLA|Test Reagents For Methyl Alcohol|2||N|P||862.3040|1|||||N|N
TX|TX|DLB|Radioimmunoassay, Lsd (125-I)|2||N|P||862.3580|1|||||N|N
TX|TX|DLD|Thin Layer Chromatography, Codeine|2||N|Y||862.3270|1|||||N|N
TX|TX|DLE|Reagents, Test,  Bromides|2||N|P||862.3645|1|||||N|N
TX|TX|DLF|Enzyme Immunoassay, Ethosuximide|2||N|P||862.3380|1|||||N|N
TX|TX|DLH|Gas Chromatography, Alcohol|2||N|P||862.3040|1|||||N|N
TX|TX|DLI|Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase|1||N|Y||862.3240|7|||||N|N
TX|TX|DLJ|Calibrators, Drug Specific|2||N|Y||862.3200|1|||||N|N
TX|TX|DLN|Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)|2||N|Y||862.3250|1|||||N|N
TX|TX|DLP|Radioimmunoassay, Diphenylhydantoin|2||N|P||862.3350|1|||||N|N
TX|TX|DLR|Hemagglutination Inhibition, Morphine|2||N|Y||862.3640|1|||||N|N
TX|TX|DLS|Gas Chromatograph, Alcohol (Dedicated Instruments)|2||N|P||862.3040|1|||||N|N
TX|TX|DLT|Hemagglutination, Opiates|2||N|Y||862.3650|1|||||N|N
TX|TX|DLX|Hemagglutination Inhibition, Barbiturate|2||N|P||862.3150|1|||||N|N
TX|TX|DLZ|Enzyme Immunoassay, Phenobarbital|2||N|P||862.3660|1|||||N|N
TX|TX|DMB|Gas Chromatography, Methadone|2||N|Y||862.3620|1|||||N|N
TX|TX|DMF|Gas Liquid Chromatography, Barbiturate|2||N|P||862.3150|1|||||N|N
TX|TX|DMI|Potassium Dichromate Specific Reagent For Alcohol|2||N|P||862.3040|1|||||N|N
TX|TX|DMJ|Test Reagents For Ethyl Alcohol|2||N|P||862.3040|1|||||N|N
TX|TX|DMK|Lead, Protoporphyrin, Fluorometric|2||N|P||862.3550|1|||||N|N
TX|TX|DML|Nad-Nadh, Specific Reagent For Alcohol Enzyme Method|2||N|P||862.3040|1|||||N|N
TX|TX|DMN|Thin Layer Chromatography, Cocaine|2||N|Y||862.3250|1|||||N|N
TX|TX|DMP|Digoxin Control Serum, Ria|1||N|Y||862.3280|1|||||N|N
TX|TX|DMQ|Gas Chromatography, Primidone|2||N|P||862.3680|1|||||N|N
TX|TX|DMR|Solution, M-Nitrophenol, Specific Reagent For Cholinesterase|1||N|Y||862.3240|7|||||N|N
TX|TX|DMT|Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet|2||N|P||862.3040|1|||||N|N
TX|TX|DMX|Liquid Chromatography, Salicylate|2||N|P||862.3830|1|||||N|N
TX|TX|DMY|Gas Chromatography, Morphine|2||N|Y||862.3640|1|||||N|N
TX|TX|DNA|Radioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody|2||N|Y||862.3640|1|||||N|N
TX|TX|DNC|Strip, Paper, Salicylate|2||N|P||862.3830|1|||||N|N
TX|TX|DND|Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.|2||N|P||862.3300|1|||||N|N
TX|TX|DNE|Atomic Absorption, Antimony|1||N|Y||862.3110|1|||||N|N
TX|TX|DNF|Liquid Chromatography, Ethosuximide|2||N|P||862.3380|1|||||N|N
TX|TX|DNG|Free Radical, Benzoylecgnonine|2||N|Y||862.3250|1|||||N|N
TX|TX|DNI|Liquid Chromatography, Amphetamine|2||N|Y||862.3100|1|||||N|N
TX|TX|DNJ|Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.|2||N|P||862.3320|1|||||N|N
TX|TX|DNK|Thin Layer Chromatography, Morphine|2||N|Y||862.3640|1|||||N|N
TX|TX|DNL|Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.|2||N|P||862.3320|1|||||N|N
TX|TX|DNN|Calibrators, Ethyl Alcohol|2||N|Y||862.3200|1|||||N|N
TX|TX|DNO|Hemagglutination Inhibition, Gentamicin|2||N|P||862.3450|1|||||N|N
TX|TX|DNP|Thin Layer Chromatography, Ethosuximide|2||N|P||862.3380|1|||||N|N
TX|TX|DNQ|Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Coated Tubes Sep.|2||N|P||862.3320|1|||||N|N
TX|TX|DNS|Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Double Label Sep.|2||N|P||862.3320|1|||||N|N
TX|TX|DNT|Liquid Chromatography, Methadone|2||N|Y||862.3620|1|||||N|N
TX|TX|DNW|Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep.|2||N|P||862.3300|1|||||N|N
TX|TX|DNX|Lead, Protoporphyrin Zinc Method, Fluorometric|2||N|P||862.3550|1|||||N|N
TX|TX|DNZ|Atomic Absorption, Arsenic|1||N|Y||862.3120|1|||||N|N
TX|TX|DOA|Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.|2||N|P||862.3320|1|||||N|N
TX|TX|DOB|Radioimmunoassay, Digitoxin (3-H)|2||N|P||862.3300|1|||||N|N
TX|TX|DOD|Gas Chromatography, Amphetamine|2||N|Y||862.3100|1|||||N|N
TX|TX|DOE|Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.|2||N|Y||862.3640|1|||||N|N
TX|TX|DOF|Lead, Atomic Absorption|2||N|P||862.3550|1|||||N|N
TX|TX|DOG|Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol|2||N|P||862.3320|1|||||N|N
TX|TX|DOH|Electrometry, Cholinesterase|1||N|Y||862.3240|7|||||N|N
TX|TX|DOJ|Potassium Dichromate, Alcohol|2||N|P||862.3040|1|||||N|N
TX|TX|DOK|Free Radical Assay, Morphine|2||N|Y||862.3640|1|||||N|N
TX|TX|DOL|Free Radical Assay, Lsd|2||N|P||862.3580|1|||||N|N
TX|TX|DOM|Thin Layer Chromatography, Benzoylecgnonine|2||N|Y||862.3250|1|||||N|N
TX|TX|DON|Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.|2||N|P||862.3320|1|||||N|N
TX|TX|DOO|Liquid Chromatography, Phenobarbital|2||N|P||862.3660|1|||||N|N
TX|TX|DOR|Radioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep.|2||N|P||862.3320|1|||||N|N
TX|TX|DOS|Thin Layer Chromatography, Primidone|2||N|P||862.3680|1|||||N|N
TX|TX|DOW|Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Coated Tube|2||N|P||862.3300|1|||||N|N
TX|TX|DOX|Fluorometer, Lead (Dedicated Instruments)|2||N|P||862.3550|1|||||N|N
TX|TX|DOY|Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.|2||N|P||862.3320|1|||||N|N
TX|TX|DOZ|Liquid Chromatography, Diphenylhydantoin|2||N|P||862.3350|1|||||N|N
TX|TX|DPB|Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.|2||N|P||862.3320|1|||||N|N
TX|TX|DPD|Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.|2||N|P||862.3320|1|||||N|N
TX|TX|DPE|Thin Layer Chromatography, Diphenylhydantoin|2||N|P||862.3350|1|||||N|N
TX|TX|DPG|Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.|2||N|P||862.3300|1|||||N|N
TX|TX|DPH|Mercury, Atomic Absorption|1||N|Y||862.3600|1|||||N|N
TX|TX|DPI|Radioimmunoassay, Digoxin (125-I), Bovine Antibody, Charcoal Sep.|2||N|P||862.3320|1|||||N|N
TX|TX|DPJ|Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.|2||N|Y||862.3100|1|||||N|N
TX|TX|DPK|Liquid Chromatography, Morphine|2||N|Y||862.3640|1|||||N|N
TX|TX|DPL|Radioimmunoassay, Digitoxin (125-I), Bovine Antibody, Charcoal Sep.|2||N|P||862.3300|1|||||N|N
TX|TX|DPN|Thin Layer Chromatography, Propoxyphene|2||N|P||862.3700|1|||||N|N
TX|TX|DPO|Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.|2||N|P||862.3320|1|||||N|N
TX|TX|DPP|Free Radical Assay, Methadone|2||N|Y||862.3620|1|||||N|N
TX|TX|DPQ|Liquid Chromatography, Primidone|2||N|P||862.3680|1|||||N|N
TX|TX|JIH|Flame Photometry, Lithium|2||N|P||862.3560|1|||||N|N
TX|TX|JII|Atomic Absorption, Lithium|2||N|P||862.3560|1|||||N|N
TX|TX|JKQ|Gold Chloride (Colorimetric), Bromide|2||N|P||862.3645|1|||||N|N
TX|TX|JKS|Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide|1||N|Y||862.3220|7|||||N|N
TX|TX|JKT|Gas Chromatograph, Carbon-Monoxide|1||N|Y||862.3220|7|||||N|N
TX|TX|JXM|Enzyme Immunoassay, Benzodiazipine|2||N|P||862.3170|1|||||N|N
TX|TX|JXN|Enzyme Immunoassay, Propoxyphene|2||N|P||862.3700|1|||||N|N
TX|TX|JXO|Enzyme Immunoassay, Cocaine|2||N|Y||862.3250|1|||||N|N
TX|TX|KJI|Radioimmunoassay, Kanamycin|2||N|P||862.3520|1|||||N|N
TX|TX|KLB|Radioimmunoassay, Tobramycin|2||N|P||862.3900|1|||||N|N
TX|TX|KLN|Radioimmunoassay, Cocaine Metabolite|2||N|Y||862.3250|1|||||N|N
TX|TX|KLO|Enzymatic Radiochemical Assay, Gentamicin|2||N|P||862.3450|1|||||N|N
TX|TX|KLP|Amikacin Serum Assay|2||N|P||862.3035|1|||||N|N
TX|TX|KLQ|Radioimmunoassay, Amikacin|2||N|P||862.3035|1|||||N|N
TX|TX|KLR|Enzyme Immunoassay, Lidocaine|2||N|P||862.3555|1|||||N|N
TX|TX|KLS|Enzyme Immunoassay, Theophylline|2||N|P||862.3880|1|||||N|N
TX|TX|KLT|Enzyme Immunoassay, Carbamazepine|2||N|P||862.3645|1|||||N|N
TX|TX|KXS|Radioimmunoassay, Methaqualone|2||N|P||862.3630|1|||||N|N
TX|TX|KXT|Enzyme Immunoassay, Digoxin|2||N|P||862.3320|1|||||N|N
TX|TX|KZT|Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin|2||N|P||862.3450|1|||||N|N
TX|TX|KZW|Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Kanamycin|2||N|P||862.3520|1|||||N|N
TX|TX|KZX|Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin|2||N|P||862.3900|1|||||N|N
TX|TX|KZY|High Pressure Liquid Chromatography, Barbiturate|2||N|P||862.3150|1|||||N|N
TX|TX|KZZ|Gas Chromatography, Benzodiazipine|2||N|P||862.3170|1|||||N|N
TX|TX|LAA|High Pressure Liquid Chromatography, Benzodiazipine|2||N|P||862.3170|1|||||N|N
TX|TX|LAB|Thin Layer Chromatography, Benzodiazipine|2||N|P||862.3170|1|||||N|N
TX|TX|LAC|High Pressure Liquid Chromatography, Cocaine And Cocaine Metabolites|2||N|Y||862.3250|1|||||N|N
TX|TX|LAD|Gas Chromatography, Codeine|2||N|Y||862.3270|1|||||N|N
TX|TX|LAE|High Pressure Liquid Chromatography, Codeine|2||N|Y||862.3270|1|||||N|N
TX|TX|LAF|Gas Chromatography, Methamphetamine|2||N|Y||862.3610|1|||||N|N
TX|TX|LAG|High Pressure Liquid Chromatography, Methamphetamine|2||N|Y||862.3610|1|||||N|N
TX|TX|LAH|High Pressure Liquid Chromatography, Opiates|2||N|Y||862.3650|1|||||N|N
TX|TX|LAI|Thin Layer Chromatography, Opiates|2||N|Y||862.3650|1|||||N|N
TX|TX|LAJ|Gas Chromatography, Propoxyphene|2||N|P||862.3700|1|||||N|N
TX|TX|LAK|High Pressure Liquid Chromatography, Propoxyphene|2||N|P||862.3700|1|||||N|N
TX|TX|LAL|Eas Chromatography, Quinine|1||N|Y||862.3750|1|||||N|N
TX|TX|LAM|High Pressure Liquid Chromatography, Quinine|1||N|Y||862.3750|1|||||N|N
TX|TX|LAN|Enzyme Immunoassay, N-Acetylprocainamide|2||N|P||862.3320|1|||||N|N
TX|TX|LAR|Enzyme Immunoassay, Procainamide|2||N|P||862.3320|1|||||N|N
TX|TX|LAS|Drug Specific Control Materials|1||N|Y||862.3280|1|||||N|N
TX|TX|LAT|Radioimmunoassay, Cannabinoid(S)|2||N|Y||862.3870|1|||||N|N
TX|TX|LAW|Theophylline Control Materials|1||N|Y||862.3280|1|||||N|N
TX|TX|LAX|Lidocaine Control Materials|1||N|Y||862.3280|1|||||N|N
TX|TX|LAY|Methotrexate Control Materials|1||N|Y||862.3280|1|||||N|N
TX|TX|LAZ|N-Acetylprocainamide Control Materials|1||N|Y||862.3280|1|||||N|N
TX|TX|LBA|Procainamide Control Materials|1||N|Y||862.3280|1|||||N|N
TX|TX|LBZ|Enzyme Immunoassay, Quinidine|2||N|P||862.3320|1|||||N|N
TX|TX|LCA|Radioimmunoassay, Theophylline|2||N|P||862.3880|1|||||N|N
TX|TX|LCD|Enzyme Immunoassay, Gentamicin|2||N|P||862.3450|1|||||N|N
TX|TX|LCM|Enzyme Immunoassay, Phencyclidine|2||N|Y||862.3100|1|||||N|N
TX|TX|LCQ|Fluorescent Immunoassay Gentamicin|2||N|P||862.3450|1|||||N|N
TX|TX|LCR|Fluorescent Immunoassay, Tobramycin|2||N|P||862.3900|1|||||N|N
TX|TX|LCS|Radioimmunoassay, Digoxin (125-I)|2||N|P||862.3320|1|||||N|N
TX|TX|LCT|Radioimmunoassay, Digoxin (3-H)|2||N|P||862.3320|1|||||N|N
TX|TX|LCW|Radioimmunoassay, Digitoxin (125-I)|2||N|P||862.3300|1|||||N|N
TX|TX|LCY|U.V. Spectrometry, Theophylline|2||N|P||862.3880|1|||||N|N
TX|TX|LCZ|U.V. Spectrometry, Primidone|2||N|P||862.3680|1|||||N|N
TX|TX|LDA|U.V. Spectrometry, Phenobarbital|2||N|P||862.3660|1|||||N|N
TX|TX|LDB|U.V. Spectrometry, Carbamazepine|2||N|P||862.3645|1|||||N|N
TX|TX|LDC|U.V. Spectrometry, Diphenylhydantoin|2||N|P||862.3350|1|||||N|N
TX|TX|LDJ|Enzyme Immunoassay, Cannabinoids|2||N|Y||862.3870|1|||||N|N
TX|TX|LDN|Enzymatic Radiochemical Assay, Amikacin|2||N|P||862.3035|1|||||N|N
TX|TX|LDO|Enzymatic Radiochemical Assay, Tobramycin|2||N|P||862.3900|1|||||N|N
TX|TX|LDP|Colorimetry, Acetaminophen|2||N|P||862.3030|1|||||N|N
TX|TX|LEG|Enzyme Immunoassay, Valproic Acid|2||N|P||862.3645|1|||||N|N
TX|TX|LEH|Radioimmunoassay, Vancomycin|2||N|P||862.3950|1|||||N|N
TX|TX|LER|Fluorescent Immunoassay, Theophylline|2||N|P||862.3880|1|||||N|N
TX|TX|LES|Fluorescent Immunoassay, Diphenylhydantoin|2||N|P||862.3350|1|||||N|N
TX|TX|LET|Fluorescent Immunoassay, Phenobarbital|2||N|P||862.3660|1|||||N|N
TX|TX|LEW|Thin Layer Chromatography, Theophylline|2||N|P||862.3880|1|||||N|N
TX|TX|LFG|Radioimmunoassay, Tricyclic Antidepressant Drugs|2||N|P||862.3910|1|||||N|N
TX|TX|LFH|U.V. Spectrometry, Tricyclic Antidepressant Drugs|2||N|P||862.3910|1|||||N|N
TX|TX|LFI|High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs|2||N|P||862.3910|1|||||N|N
TX|TX|LFM|Enzyme Immunoassay, Digitoxin|2||N|P||862.3300|1|||||N|N
TX|TX|LFN|Nephelometric Inhibition Immunoassay, Phenobarbital|2||N|P||862.3660|1|||||N|N
TX|TX|LFO|Nephelometric Inhibition Immunoassay, Diphenylhydantoin|2||N|P||862.3350|1|||||N|N
TX|TX|LFT|Fluorescent Immunoassay, Primidone|2||N|P||862.3680|1|||||N|N
TX|TX|LFW|Fluorescence Polarization Immunoassay, Tobramycin|2||N|P||862.3900|1|||||N|N
TX|TX|LGI|Fluorescence Polarization Immunoassay, Carbamazepine|2||N|P||862.3645|1|||||N|N
TX|TX|LGJ|Fluorescence Polarization Immunoassay, Amibacin|2||N|P||862.3035|1|||||N|N
TX|TX|LGQ|Fluorescence Polarization Immunoassay, Phenobarbital|2||N|P||862.3660|1|||||N|N
TX|TX|LGR|Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)|2||N|P||862.3350|1|||||N|N
TX|TX|LGS|Fluorescence Polarization Immunoassay, Theophylline|2||N|P||862.3880|1|||||N|N
TX|TX|LPX|Radioceptor Assay, Neuroleptic Drugs|2||N|P||862.3645|1|||||N|N
TX|TX|MKU|Enzyme Immunoassasy, Nocotine And Nicotine Metabolites|1||N|Y||862.3220|7|||||N|N
TX|TX|MLK|Thin Layer Chroomatography, Tricyclic Antidepressant Drugs|2||N|P||862.3910|1|||||N|N
TX|TX|MOJ|Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)|2||N|P||862.3350|1|||||N|N
TX|TX|MRS|Test System, Nicotine, Cotinine, Metabolites|1||N|Y||862.3220|4|||||N|N
TX|TX|NDW|Assay, Porphyrin, Spectrophotometry, Lithium|2||N|P||862.3560|1|||||N|N
TX|TX|NFT|Test, Amphetamine, Over The Counter|2||N|N||862.3100|1|||||N|N
TX|TX|NFV|Test, Benzodiazepine, Over The Counter|2||N|N||862.3170|1|||||N|N
TX|TX|NFW|Test, Cannabinoid, Over The Counter|2||N|N||862.3870|1|||||N|N
TX|TX|NFY|Test, Cocaine And Cocaine Metabolites, Over The Counter|2||N|N||862.3250|1|||||N|N
TX|TX|NGG|Test, Methamphetamine, Over The Counter|2||N|N||862.3610|1|||||N|N
TX|TX|NGI|Test, Morphine, Over The Counter|2||N|N||862.3640|1|||||N|N
TX|TX|NGL|Test, Opiates, Over The Counter|2||N|N||862.3650|1|||||N|N
TX|TX|NRP|Sirolimus Test System|2||N|N||862.3840|1|Sirolimus test systems are intended for the quantitative measurement of sirolimus in whole blood as an aid in management of transplant patients taking this sirolimus.||||N|N
TX|TX|NTI|Drug Metabolizing Enzyme Genotyping Systems|2||N|N||862.3360|1|Intended to identify the presence or absence of human genotypic markers encoding drug metaboizing enzymes using dna originating from clinical samples. This type of assay can be used as an aid determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme tested by the system.||||N|N
TX|TX|NWM|Immunoassay, Anti-Seizure Drug|2||N|N||862.3350|1|To aid in management of patients treated with anti-seizure drug.|liquid reagents|Immunoassay intented for use on clinical chemistry analyzers|in vitro diagnostic|N|N
TX|TX|OAV|Mycophenolic Acid Test System|2||N|N||862.3840|1|An in vitro diagnostic reagent system intended for use in the quantitative determination of total mycophenolic acid in human serum or plasma as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients.|Liquid|Enzyme-mimicking assay with MPA concentration inversely proportional to the formation of NADH.|Renal and Cardiac Transplant Patients|N|N
TX|TX|ODW|Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System|2||N|N||862.3360|1|An in vitro diagnostic assay for use in genotyping Cytochrome P450 2C9 (CYP450 2C9) alleles.  Information about the CYP2C9 genotype may be used as an aid to clinicians in determining therapeutic strategy for medications that are metabolized by the CYP2C9 gene product.|genotyping test system|Uses DNA genotyping technology to determine patient genotype at the Cytochrome P450 2C9 (CYP450 2C9) locus.|clinical samples (blood, saliva, buccal swab samples)|N|N
TX|TX|OIW|Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types|2||N|N||862.3100|1|This test is intended to measure the degree of similarity between the RNA expression pattern in a patient?s fresh-frozen tumor and the RNA expression patterns in a database of tumor samples for some common malignant tumor types that were diagnosed according to then current clinical and pathological practice. The test result is intended for use in the context of the patient?s clinical history and other diagnostic tests evaluated by a qualified clinician.  The test is not intended to establish the origin of tumors (e.g. carcinoma of unknown primary) that cannot be diagnosed according to current clinical and pathological practice.|Gene expression systems, which include either microarray systems or reverse-transcriptase polymerase chain reaction (RT-PCR) systems.  Steps for microarray systems include RNA isolation kits, cDNA synthesis kits, in vitro transcription kits, hybridization, washing and staining systems, scanner, and computer|Uses Gene expression and computer algorithm that estimate degree of similarity between analyzed specimen and examples of various tumor types comprising a database.  Gene expression involves isolation of RNA from frozen tumor tissue sections, amplification of RNA and hybridization, and comparison of hybridization patterns.|Fresh frozen tumor tissue sections|N|N
TX|TX|ORA|Breast Milk-Alcohol Test System|2||N|N||862.3040|1|Is intended for use by consumers at home as a qualitative test to identify the presence of alcohol in breast milk.|Should not include serum, plasma or urine|Intended to detect the presence of alcohol in breast milk. the test utilizes an emzymatically catalyzed reaction of ethyl alcohol in the presence of oxygen to produce hydrogen peroxide. The peroxide produced along with a dye substrate, are enzymatically catalyzed with peroxidase to form a colored gree/blue dye. The initial reaction is catalyzed by alcohol oxidase enzyme produced from yeast whixh is specific to ethonal, methanol, isopropanol and will not react with alcohol having five or more carbons or with glycine, glycerol or serine.|Breast milk|N|N
TX|TX|ORH|Lamotrigine Assay|2||N|N||862.3350|1|for the quantitative determination of  lamotrigine in human serum or plasma on automated clinical chemistry analyzers.|monitoring of anti-seizure drug|Immunoassay|in vitro diagnostic|N|N
TX|TX|ORI|Levetiracetam Assay|2||N|N||862.3350|1|For the quantitative determination of levetiracetam in human serum or plasma.|measurement of anit-seizure medication|immunoassay|in vitro diagnostic|N|N
TX|TX|OTF|Gabapentin Assay|2||N|N||862.3350|1|Test for the quantitative determination of gabapentin in human serum or plasma.  Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin.|Liquid reagents|Quantitative, Homogenous Enzyme Immunoassay|in vitro diagnostic|N|N
TX|TX|OUF|Everolimus Immunoassay|2||N|N||862.3840|1|To quantify everolimus in whole blood.|NA|immunoassay|IVD|N|N
TX|TX|PDY|Organophosphate Test System|2||N|N||862.3652|1|For the quantitation of specific organophosphate metabolites in human urine from individuals who have signs and symptoms consistent with cholinesterase poisoning.  The data obtained by this device is intended to aid in the confirmation and investigation of organophosphate exposure.|solid-phase extraction cartridge, mass spectrometer, HPLC|Urine is diluted in acetonitrile and separated using normal phase solid-phase extraction which is further concentrated  so that the analytes can be ionized via mass spectrometry.|Not applicable|N|N
TX||DJM|Test Reagents, Zinc|U|1|N|N|||1|||||N|N
TX||DJW|Test Reagents For Chloral Hydrate|U|1|N|N|||1|||||N|N
TX||LAO|Enzyme Immunoassay, Methotrexate|U|1|N|N|||1|||||N|N
TX||LAP|Radioassay, Methotrexate, Enzyme|U|1|N|N|||1|||||N|N
TX||LBY|Radioimmunoassay, Sisomicin|U|1|N|N|||1|||||N|N
TX||LCE|Radioimmunoassay, Netilmicin (I-125)|U|1|N|N|||1|||||N|N
TX||LCK|Thin Layer Chromatography, Phencyclidine|U|1|N|N|||1|||||N|N
TX||LCL|Radioimmunoassay, Phencyclidine|U|1|N|N|||1|||||N|N
TX||LTD|Paraquat Assay|3||N|N|||3|||||N|N
TX||MGX|Test System, For Drugs Of Abuse|3||N|N|||2|||||N|N
TX||MIG|Strip, Test Isoniazid|U|1|N|N|||1|||||N|N
TX||MSK|Immunoassay For Blood Tacrolimus|N|4|N|N|||3|||||N|Y
TX||MSL|System, Test, Topiramatee|U|1|N|N|||1|||||N|N
TX||MVO|Kit, Test, Multiple, Drugs Of Abuse, Over The Counter|U|1|N|N|||1|||||N|N
TX||OTW|Research Use Only/Clinical Toxicology|N|6|Y|N|||7|For research use only and for products imported into the US only.|N/A|N/A|N/A|N|N
TX||OXR|5-Fluorouracil Assay|N|3|N|N|||3|Measures levels of a chemotherapy drug in the blood.|Measures levels of a chemotherapy drug in the blood|Measures levels of a chemotherapy drug in the blood|the blood|N|N
TX||PDB|Investigational Use Only - Clinical Toxicology|N|6|Y|N|||7|Investigational use only and for products imported into the US only.|N/A|N/A|N/A|N|N
TX||PGE|Gastric Emptying Breath Test|3||N|N|||2|Gastric emptying breath tests are intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastoparesis.The test system typically utilizes a Mass Spectrometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples following the ingestion of a 13C-labeled test meal.|test kit, mass spectrometerSystem, 13C-labeled test meal, and associated software|Baseline breath samples are collected prior to the administration of test meal.  After an overnight fast, the patient consumes a 13C-labeled test meal and post-meal breath samples are collected at multiple time points after meal ingestion.  As the meal is digested, 13CO2 is given off in the patient¿s breath.  All pre- and post-meal breath samples are collectedand analyzed by a mass spectrometer to determine the ratio of 13CO2/12CO2 in each sample.|Breath samples from patients|N|N
TX||PKM|Chemiluminescent Immunoassay System|N|3|N|N|||7|for in vitro diagnostic use in the quantitative measurement of hyaluronic acid in human serum.|n/a|Chemiluminescent immunoassay|in vitro|N|N
||RAA|Laser Products (Pre-Standard)|N||N|N||||A laser product assembled or manufactured before August 1, 1976||||N|N
||RAB|Sunlamp Products (Pre-Standard)|N||N|N||||A sunlamp product assembled or manufactured before november 9, 1979.||||N|N
||RAC|Nondestructive Tests|N||N|N||||Test equipment using ultrasound to analyze an object for defects in commercial or industrial applications||||N|N
||RAD|Gauging|N||N|N||||Test equipment using ultrasound to determine thickness of material in commercial or industrial applications||||N|N
||RAE|Ranging|N||N|N||||Test equipment used to determine distance to an object using ultrasound in commercial or industrial applications||||N|N
||RAF|Cleaner|N||N|N||||Equipment using ultrasound  to clean objects in commercial or industrial applications||||N|N
||RAG|Welder|N||N|N||||Equipment used to weld objects  in commercial or industrial applications||||N|N
||RAH|Jewelry Cleaner|N||N|N||||Equipment using ultrasound to clean jewelry in commercial or household applications||||N|N
||RAI|Motion Detector/Occupancy|N||N|N||||Equipment using ultrasound to detect movement in commercial or household applications||||N|N
||RAJ|Security System|N||N|N||||Equipment using ultrasound to provide security in a commercial or household application||||N|N
||RAK|Pest Repeller|N||N|N||||Equipment using ultrasound to repel pests in a commercial or household application||||N|N
||RAL|Massager|N||N|N||||Equipment using ultrasound to provide massages in a household application that has no medical claims.||||N|N
||RAM|Humidifier|N||N|N||||Equipment using ultrasound to disperse water droplets into an area in a household application||||N|N
||RAN|Auto Focus Camera|N||N|N||||Photography equipment using ultrasound to provide range to subject||||N|N
||RAO|Intrusion Alarm/Security|N||N|N||||Equipment using ultrasound to provide security and an intrusion alarm in a commercial or household application||||N|N
||RAP|Scientific Use Ultrasound Products|N||N|N||||Equipment using ultrasound in research or scientific application||||N|N
||RAQ|Audio System/Radio|N||N|N||||Equipment used to produce audible sound in household entertainment applications||||N|N
||RAR|Telephone Ringer|N||N|N||||Equipment used to produce a ring tone on a telephone||||N|N
||RAS|Veterinary Diagnostic Ultrasonic Products|N||N|N||||Equipment using ultrasound to diagnose disease in veterinary applications||||N|N
||RAT|Veterinary Therapy Ultrasonic Products|N||N|N||||Equipment using ultrasound to provide physical therapy in veterinary applications||||N|N
||RAU|Night Vision Scope|N||N|N||||An optical device that converts infrared radiation into a visible image through use of an image intensifier tube.||||N|N
||RAV|High Voltage Tubes|N||N|N||||Vacuum tubes used in high voltage electronic circuits for purposes other than producing an image.||||N|N
||RAW|Cathode Ray Tubes|N||N|N||||A vacuum tube generating a focused beam of electrons that can be deflected by electric fields, magnetic fields or both.||||N|N
||RAX|High Voltage Vacuum Switches|N||N|N||||A vacuum tube used for switching high voltages.||||N|N
||RAY|Oscilloscope (Exempted)|N||N|N||||A device that depicts on a screen periodic changes in an electric quantity, as voltage or current, using a cathode ray tube.||||N|N
||RAZ|Television Receiver, Medical Imaging, Color|N||N|N||||A television receiver using a color cathode ray tube to display medical images in colors.||||N|N
||RBA|Television Receiver, Medical Imaging, Monochrome|N||N|N||||A television receiver using a monochrome cathode ray tube to display medical images in black and white with shades of gray or in different shades of one color.||||N|N
||RBB|Television Receiver, General Purpose, Color|N||N|N||||An electronic product designed to receive and, using a color cathode ray tube, to display a television picture in colors from broadcast, cable, video disk player, video recorder, computer or closed circuit television signals.||||N|N
||RBC|Television Receiver, General Purpose, Monochrome|N||N|N||||An electronic product designed to receive and, using a monochrome cathode ray tube, to display a television picture in black and white with shades of gray or in different shades of one color from broadcast, cable, video disk player, video recorder, computer or closed circuit television signals.||||N|N
||RBD|Video Monitor, Medical Imaging, Color|N||N|N||||An electronic product using a color cathode ray tube to display medical images in colors from signals from a computer or electronic medical device.||||N|N
||RBE|Video Monitor, General Purpose, Color|N||N|N||||An electronic product using a color cathode ray tube to display general images in colors from signals from a computer or electronic medical device.||||N|N
||RBF|Video Monitor, Medical Imaging, Monochrome|N||N|N||||An electronic product using a monochrome cathode ray tube to display medical images in black and white with shades of gray or in different shades of one color from signals from a computer or electronic medical device.||||N|N
||RBG|Video Monitor, General Purpose, Monochrome|N||N|N||||An electronic product using a monochrome cathode ray tube to display general images in black and white with shades of gray or in different shades of one color from signals from a computer or electronic medical device.||||N|N
||RBH|Projector|N||N|N||||Electronic products that use a cathode ray tube or several cathode ray tubes to generate television images which are projected on a screen either from the front or from the rear.||||N|N
||RBI|Tv View Finder (Exempted)|N||N|N||||An electronic product using a cathode ray tube to display the image seen through the lens of a camcorder.  To be exempt the cathode ray tube must operate under 5 kilovolts under the test conditions in the standard (phase iii).||||N|N
||RBJ|Cold-Cathode Gas Discharge Tubes|N||N|N||||An electronic device in which electron flow is produced and sustained by ionization of contained gas and ion bombardment of the cathode.||||N|N
||RBK|Betatron, Non-Medical|N||N|N||||A betatron used for non-medical applications.||||N|N
||RBL|Cyclotron,Non-Medical|N||N|N||||A cyclotron used for non-medical applications.||||N|N
||RBM|Microtron, Non-Medical|N||N|N||||A microtron used for non-medical applications.||||N|N
||RBN|Synchrotron, Non-Medical|N||N|N||||A synchrotron used for non-medical applications.||||N|N
||RBO|Sterilizers, Non-Medical|N||N|N||||A linear accelerator used as a sterilizer for non-medical instruments and applications.||||N|N
||RBP|Industrial Accelerator|N||N|N||||An accelerator used for industrial applications.||||N|N
||RBQ|Security Accelerator|N||N|N||||A linear accelerator used to non-intrusively search the contents of closed objects such as cargo containers or vehicles for contraband or weapons.||||N|N
||RBR|Diagnostic X-Ray Equipment (Noncertified)|N||N|N||||Diagnostic x-ray equipment or components manufactured before the dates specified in the applicability section in 21 cfr 1020.30(a).||||N|N
||RBS|Industrial X-Ray|N||N|N||||An x-ray system used for industrial purposes to which the cabinet x-ray performance standard does not apply (21 cfr 1020.40).||||N|N
||RBT|Bottle Fill Checker|N||N|N||||an industrial x-ray system open on the bottom which is used on production lines to determine if containers are filled properly.||||N|N
||RBU|X-Ray Thickness Gauge|N||N|N||||An open industrial x-ray system used to measure the thickness of material running through system, usually on a production line.||||N|N
||RBV|Security X-Ray System, Open Beam, Small|N||N|N||||An open x-ray system which is used for non-intrusive inspection of containers suspected to contain bombs or other weapons or contraband.||||N|N
||RBW|X-Ray Diffraction|N||N|N||||An x-ray system used for x-ray diffraction and used in a laboratory environment.||||N|N
||RBX|X-Ray Spectroscopy|N||N|N||||An x-ray system used for x-ray spectroscopy and used in a laboratory environment.||||N|N
||RBY|X-Ray Fluorescence|N||N|N||||An x-ray system for x-ray fluorescence and used in a laboratory environment.||||N|N
||RBZ|X-Ray Controls ? Combination|N||N|N||||A device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices which control the technique factors of an x-ray exposure.||||N|N
||RCA|X-Ray Controls - Fluoroscopic|N||N|N||||A device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices which control the technique factors of an x-ray exposure for generating x-ray images and presenting them simultaneously and continuously as visible images.||||N|N
||RCB|X-Ray Controls - Radiographic|N||N|N||||A device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices which control the technique factors of an x-ray exposure for generating and recordingan x-ray pattern for the purpose of providing the user with an image(s) after termination of the exposure.||||N|N
||RCC|C-Arm Fluoroscopic X-Ray System|N||N|N||||Fluoroscopic x-ray system in which the image receptor and x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient.||||N|N
||RCD|X-Ray Image Receptor|N||N|N||||Any device, such as a fluorescent screen, radiographic film, x-ray image intensifier tube, solid-state detector, or gageous detector, which transforms incident x-ray photons either into a visible image or into another form which can be made into a visible image by further transformations. In those cases where means are provided to preselect a portion of the image receptor, the term ""image receptor"" shall mean the preselected portion of the device.||||N|N
||RCE|Cabinet X-Ray, Industrial|N||N|N||||A cabinet x-ray system used for quality control,  non-destructive testing, or some other industrial purpose.||||N|N
||RCF|Cabinet X-Ray Explosive Detection Systems|N||N|N||||A cabinet x-ray system used for detection of explosives in closed containers such as airline baggage.  Usually these systems use a non-standard x-ray mode to perform this function such as computed tomography.||||N|N
||RCG|Cabinet X-Ray, Security (Includes Baggage X-Ray)|N||N|N||||A cabinet x-ray system used to examine the contents of containers such as airline baggage, brief cases, and purses to detect weapons or other contraband.||||N|N
||RCH|Cabinet X-Ray, Vehicle And Cargo|N||N|N||||A large cabinet x-ray system used to examine pallets full of cargo to find weapons or other contraband, or a very large structure that encompasses entire vehicles being examined.||||N|N
||RCI|Cephalometric Devices|N||N|N||||A device intended for the radiographic visualization and measurement of the dimensions of the human head.||||N|N
||RCJ|Veterinary Diagnostic X-Ray System|N||N|N||||A system that is uses x-radiation to visualize anatomical structures in veterinary applications.||||N|N
||RCK|Veterinary X-Ray Therapy System|N||N|N||||Equipment using x-rays to provide therapy in veterinary applications.||||N|N
||RCL|Ion Beam Implanter|N||N|N||||An electronic system that implants ions for fabrication of semiconductor materials.||||N|N
||RCM|Microscope (Electron Beam), Non-Medical|N||N|N||||a particle beam system used to view objects or details too small to view with an optical microscope.||||N|N
||RCN|Personnel Security Backscatter X-Ray System|N||N|N||||A system intended to find contraband, explosives, and weapons concealed under the clothing of a person through the use of backscattered x-rays.||||N|N
||RCO|Personnel Security Transmission X-Ray System|N||N|N||||A system intended to find contraband, explosives, and weapons concealed under the clothing of a person or inside a person through the use of transmitted x-rays.||||N|N
||RCP|Vehicle And Cargo X-Ray System, Mobile|N||N|N||||A mobile system, usually mounted in a truck or similar conveyance which uses x-rays to find contraband, explosives, or weapons concealed in vehicles and cargo containers.||||N|N
||RCQ|Vehicle And Cargo X-Ray System, Stationary|N||N|N||||A large system often in its own architectural structure, that does not encompass entire vehicles or cargo containers, which uses x-rays to find contraband, explosives, or weapons concealed in vehicles and cargo containers which pass through the system.||||N|N
||RCR|Microwave Oven, Consumer|N||N|N||||A machine that utilizes microwave radiation for food preparation, designed for home use.||||N|N
||RCS|Microwave Oven, Commercial|N||N|N||||A machine that utilizes microwave radiation for food preparation, designed for commercial establishments||||N|N
||RCT|Tunnel/Conveyor|N||N|N||||A machine that utilizes microwave radiation for food preparation using a conveyorized or tunnel microwave waveguide.||||N|N
||RCU|Vending Machine|N||N|N||||A machine that utilizes microwave radiation for dispensing heated foods in public areas.||||N|N
||RCV|Food Processing|N||N|N||||A machine that utilizes microwave radiation for food preparation, primarly used in commercial food industry||||N|N
||RCW|Materials Processing|N||N|N||||A machine that utilizes microwave radiation for industry drying/heating of non-food products (non-dielectric heater rf sealers)||||N|N
||RCX|Clothes Dryer|N||N|N||||A machine that utilizes microwave radiation to warm and dry clothing.||||N|N
||RCY|Medical Waste/Sterilizer|N||N|N||||A machine that utilizes microwave radiation for treating or sterilizing medical waste.||||N|N
||RCZ|Materials Processing, Laboratories|N||N|N||||A machine that utilizes microwave radiation for materials processing, custom designed or modified off-shelf for laboratories.||||N|N
||RDA|Dielectric Heaters, Induction Heaters, Rf Sealers|N||N|N||||A machine that utilizes industrial radiofrequency (rf) induction heating with rf fields in frequency range from 2-500 mhz for industrial heating.||||N|N
||RDB|Electric Blanket|N||N|N||||A machine that utilizes microwave or elf radiation in an electric blanket.||||N|N
||RDC|Shavers|N||N|N||||A machine that utilizes microwave or elf radiation for shaving hair.||||N|N
||RDD|Hair Dryer|N||N|N||||A machine that utilizes microwave or elf radiation for drying hair.||||N|N
||RDE|Sewing Machine|N||N|N||||A machine that utilizes microwave or elf radiation for fabric treatment, incorporated in a sewing machine.||||N|N
||RDF|Motor|N||N|N||||A machine that utilizes microwave or elf radiation in a motor.||||N|N
||RDG|Veterinary, Microwave Medical Products|N||N|N||||A machine that utilizes microwave radiation for veterinary treatments.||||N|N
||RDH|Air Traffic Control|N||N|N||||A machine that utilizes microwave radiation associated with identification, safety, security, or surveillance in the air traffic control environment.||||N|N
||RDI|Police Radar|N||N|N||||A machine that utilizes microwave radiation associated with identification, safety, security, or surveillance in the police traffic control environment.||||N|N
||RDJ|Rf Identification|N||N|N||||A machine that utilizes microwave radiation for rf id tags for security, tracking, inventory control, surveillance, etc.||||N|N
||RDK|Electronic Article Surveillance (Eas)|N||N|N||||A machine that utilizes microwave radiation used by retailers to prevent theft of merchandise or products||||N|N
||RDL|Stun Gun|N||N|N||||A machine that utilizes microwave radiation in a stun gun used by law enforcement and military.||||N|N
||RDM|Anti-Theft Detector (Non-Eas)|N||N|N||||A machine that utilizes microwave radiation (not eas or rfid) for security, tracking, inventory control, surveillance, etc.||||N|N
||RDN|Walkie-Talkie|N||N|N||||A machine that utilizes microwave radiation for communication as in walkie talkies.||||N|N
||RDO|Microwave Lan|N||N|N||||A machine that utilizes microwave radiation for communication and data transmission in a local area network.||||N|N
||RDP|Wireless (Cordless) Telephone|N||N|N||||A machine that utilizes microwave radiation for communication in a wireless, cordless telephone.||||N|N
||RDQ|Cb Amateur Radio|N||N|N||||A machine that utilizes microwave radiation for communication in a cb amateur radio.||||N|N
||RDS|Weather Doppler|N||N|N||||A machine that utilizes microwave radiation for data and measurement transmission in a weather doppler system.||||N|N
||RDT|Rf-Excited Lighting|N||N|N||||A machine that utilizes microwave radiation for rf-excited lighting.||||N|N
||RDU|Pest Controller|N||N|N||||A machine that utilizes microwave radiation for pest control.||||N|N
||RDV|Automotive Accessory, Automobile Or Transport Vehicle|N||N|N||||A laser product or product containing a laser that is an automotive or other transport vehicle accessory.||||N|N
||RDW|General Purpose Laser Products|N||N|N||||Product, laser, general, emit beam; A laser or product containing a laser that is intended for general purpose use.||||N|N
||RDX|Mercury Vapor Lamp|N||N|N||||High intensity mercury vapor discharge lamp that is designed, intended, or promoted for illumination purposes and manufactured after march 7, 1980.||||N|N
||RDY|Metal Halide Lamp|N||N|N||||High-intensity mercury vapor discharge lamp means any lamp including any mercury vapor or metal halide lamp, with the exception of tungsten filament self-ballasted mercury vapor lamp, incorporating a high pressure arc discharge tube that has a fill consisting of mercury and that is contained within an outer envelope.||||N|N
||RDZ|Low-Power Laser Light Show Projector|N||N|N||||Product, laser, demo, projector, laser light show/display, class iiia/3r and lower; Laser projection system that incorporates a laser having a maximum radiation output of less than 5mw.||||N|N
||REA|High-Power Laser Light Show Projector|N||N|N||||Product, laser, demo, projector, laser light show/display, class iiib/iv/3b/4; Laser projection system that incorporates a laser having a maximum radiation output power greater than 5mw.||||N|N
||REB|High-Power Laser Light Show|N||N|N||||Product, laser, demo, laser light show/display, class iiib/iv/3b/4; Laser light show or demonstration using laser projection equipment having an output that exceeds 5mw||||N|N
||REC|Laser Video Projector|N||N|N||||Product, laser, demo, projector, display, video; A laser used in conjunction or incorporated in a video display system or projector.||||N|N
||RED|Laser Advertising Display System|N||N|N||||Product, laser, demo, system, display, advertising||||N|N
||REE|Laser Visual Display - Display Retinal Image, Non-Medical|N||N|N||||Product, laser, display, system, images, direct to retina||||N|N
||REI|Laser Science Education Products|N||N|N||||Product, laser, demo, education, illustrate science principles||||N|N
||REJ|Laser Toy/Novelty Product|N||N|N||||Product, laser, toy/novelty||||N|N
||REK|Research Laser|N||N|N||||Product, laser, research/laboratory; A laser under development in and of itself.  A laser used for conducting  research during development of new data or to improve a process would not be considered a research laser although it is being used in research.||||N|N
||REL|Guide-Star Laser System|N||N|N||||Product, laser, adaptive-optics telescope focusing accessory, generate artifical star; A laser used for alignment of optical telescopes.||||N|N
||REM|Spectroscopy Instrument|N||N|N||||Product, laser, instrument, spectroscopy; An instrument incorporating a laser for  spectroscopic testing or examination||||N|N
||REN|Particle-Size Measuring Instrument|N||N|N||||Product, laser, instrument, particle size measurement; An instrument or system incorporating a laser for determining  the size or number of particles of particles a test sample.||||N|N
||REO|Analytical Measuring And Detection Laser Product|N||N|N||||Product, laser, instrument, analyze/detect chemical species||||N|N
||REP|Surveying Laser Product|N||N|N||||Product, laser, surveying, instrument, determine position by measurement of angles||||N|N
||REQ|Laser Time-Of-Flight Speed Measurement Products|N||N|N||||Product, laser, measures speed by time-of-flight||||N|N
||RER|Alignment Laser Product|N||N|N||||Product, laser, alignment, aid positioning or adjusting parts in relation to each other||||N|N
||RES|Laser Pointer|N||N|N||||Product, laser, pointer, indicate point of interest; A laser product intended specifically to define a spot or surface for drawing attention to a viewer.||||N|N
||RET|Laser Target Designator|N||N|N||||Product, laser, target designator; An optical devices, using a visible beam of laser light that permits the alignment of a gun, cannon or rocket system with its target.||||N|N
||REU|Laser Aiming Product, Visible|N||N|N||||Product, laser, aiming, visible, attached to weapon; An optical devices, using a visible beam of laser light that permits the alignment of a gun, cannon or rocket system with its target||||N|N
||REV|Laser Aiming Product, Non-Visible|N||N|N||||Product, laser, aiming, infrared, attached to weapon, viewed with night-vision equipment; An optical devices, using an invisible beam of laser light that permits the alignment of a gun, cannon or rocket system with its target.||||N|N
||REW|Ir Laser Illuminator With Alignment Aid/Night Vision System|N||N|N||||Product, laser, infrared, illuminator with alignment aid, viewed through night-vision equipment||||N|N
||REX|Ir Laser Illuminator Only/Night Vision System|N||N|N||||Product, laser, infrared, illuminator only, viewed through night-vision equipment||||N|N
||REY|Collision-Avoidance Laser System|N||N|N||||Product, laser, infrared, collision-avoidance system||||N|N
||REZ|Laser Traffic Signal|N||N|N||||Product, laser, traffic signal/control||||N|N
||RFA|Laser Automotive Lighting & Signals|N||N|N||||Product, laser, automotive, lighting/signals||||N|N
||RFB|Ir Laser Intrusion Detection/Security System|N||N|N||||Product, laser, infrared, intrusion detecting, security system||||N|N
||RFC|Laser Light Distance (Or Detection) And Ranging (Lidar)|N||N|N||||Product, laser, for distance, detection or ranging measurement.||||N|N
||RFD|Laser Weapon (Military Or Police)|N||N|N||||Product, laser, weapon (military/police)||||N|N
||RFE|Laser Cutter|N||N|N||||A high power laser intended to cut or drill a variety of materials in an industrial or commercial environment.||||N|N
||RFF|Laser Welder|N||N|N||||A high power laser intended to weld (join) materials in an industrial or commercial environment.||||N|N
||RFG|Microelectronic Mask Or Chip Processing, Checking, And/Or Repair|N||N|N||||A laser intended to process, inspect, and/or repair microelectronic components in an industrial or commercial environment.||||N|N
||RFI|Print Industry Plate Maker|N||N|N||||A laser intended to etch, engrave or otherwise create printer's plates used in an industrial or commercial environment.||||N|N
||RFJ|Process Control|N||N|N||||A laser used for inspection, counting, or other application intended to monitor a part of the manufacturing process in an industrial or commercial environment.  Often incorporated in an automated process system.||||N|N
||RFK|Laser Vision|N||N|N||||A laser used for positioning, focusing, inspection, counting, or other application in an industrial or commercial environment.  Often incorporated in an automated assembly line system.||||N|N
||RFL|Laser Micrometer|N||N|N||||A laser used in high precision dimensional measurements in materials processing.||||N|N
||RFM|Laser-Based Material Positioning System|N||N|N||||A laser used in precision positioning of materials in manufacturing in an industrial or commercial environment.||||N|N
||RFN|Fiber Optic Communication And Data Transfer|N||N|N||||A laser used in fiber optic communications to transmit data and information.||||N|N
||RFO|Ir Free-Space Data Transmit/Control Laser|N||N|N||||A laser used in free space (open air) communications to transmit data and information.||||N|N
||RFP|Remote Controller|N||N|N||||A laser used to transmit signals and/or information in order to operate equipment or machinery remotely.||||N|N
||RFQ|Interferometric Position Measuring Product|N||N|N||||A laser used as an interferometer for high precision positioning and/or measurements.||||N|N
||RFR|Product Incorporating Certified Class 1 Laser Data Measurement, Transmit, Control Product|N||N|N||||A data measurement, data transmission, or remote control product that incorporates a certified class 1 laser.||||N|N
||RFS|Reprographics|N||N|N||||A reprographics machine that incorporates a laser utilized to expose internal sensitive components or materials for photocopying text and graphics.||||N|N
||RFT|Laser Printer|N||N|N||||A printing machine that incorporates a laser utilized in printing images on paper.||||N|N
||RFU|Laser Fax Machine|N||N|N||||A printing machine that incorporates a laser utilized in printing fascimilies of images on paper.||||N|N
||RFV|Cd, Cd-Rom Player|N||N|N||||A cd or cd-rom player that utilizes a laser to read data on the compact disc.||||N|N
||RFW|Dvd, Dvd-Rom, Bluray, Hd Player|N||N|N||||A dvd, dvd-rom, bluray, or high definition (hd) player that utilizes a laser to read data on the digitally recorded video disc.||||N|N
||RFX|Cd-R, Cd-Rw Recorder|N||N|N||||A cd-r or cd-rw recorder machine that utilizes a laser to read and/or write data on the compact disc.||||N|N
||RFY|Dvd, Bluray, Or Hd Recorder|N||N|N||||A dvd, bluray, or hd recorder machine that utilizes a laser to read and write or read, write, and erase data on a digitally recorded video disc in any of the data formats: Dvd-r, dvd+r, dvd-ram, dvd-rw, or dvd+rw, or bluray or hd recorders or read/writers.||||N|N
||RFZ|Upc Reader (Bar Code Reader)|N||N|N||||A laser used to scan across a bar code to identify the product.  Bar code readers can be hand-held accessories, under-counter components incorporated in store check-out systems, or laser scanner systems incorporated in assembly lines used for identification and inventory purposes in manufacturing facilities, warehouses and storage facilities, or other consumer, industrial, health care, or commercial locations.||||N|N
||RGA|Product Incorporating Certified Class 1 Data Utility/Peripheral Laser Product|N||N|N||||A utility/peripheral laser product that incorporates a certified class 1 laser.||||N|N
||RGB|Veterinary Laser|N||N|N||||A laser used for treatment of animals other than human||||N|N
||RGC|X-Ray Field Indicator Light (Laser)|N||N|N||||A laser incorporated in a diagnostic x-ray system that is irradiated onto the film screen area indicating the x-radiation area.  The beam is usually scanned to show a rectangular region for patient placement.||||N|N
||RGD|Counterfeit Detection|N||N|N||||An ultraviolet wavelength noncoherent light source used for detection of counterfeit money.||||N|N
||RGE|Scientific Crystallography|N||N|N||||An ultraviolet wavelength noncoherent light source used in crystallography for identification.||||N|N
||RGF|Forensics|N||N|N||||An ultraviolet wavelength noncoherent light source used in forensics for fingerprint detection.||||N|N
||RGG|Forensics Laser|N||N|N||||An ultraviolet wavelength laser used in forensics for fingerprint detection.||||N|N
||RGH|Toilet Seat Sanitizer|N||N|N||||An ultraviolet wavelength noncoherent light source used for sanitizing toilet seats.||||N|N
||RGI|Hand Washing Sanitizer|N||N|N||||An ultraviolet wavelength noncoherent light source used for sanitizing hands after washing.||||N|N
||RGJ|Countertop Sanitizer|N||N|N||||An ultraviolet wavelength noncoherent light source used for sanitizing a countertop.||||N|N
||RGK|Towel Cleaner|N||N|N||||An ultraviolet wavelength noncoherent light source used for sanitizing towels in a towel washing process.||||N|N
||RGM|Photochemical Curing And Adhesive|N||N|N||||An ultraviolet wavelength noncoherent light source used to illuminate a material of a certain composition such that the light ""cures"" or causes a chemical reaction to change the material in a desired fashion. Typical materials are adhesives, plastics, potting compounds, etc.||||N|N
||RGN|Photochemical Curing And Adhesive Laser|N||N|N||||An ultraviolet wavelength laser light source used to illuminate a material of a certain composition such that the light ""cures"" or causes a chemical reaction to change the material in a desired fashion. Typical materials are adhesives, plastics, potting compounds, etc.||||N|N
||RGO|Uv Curing|N||N|N||||An ultraviolet wavelength noncoherent light source used to illuminate a material of a certain composition such that the light ""cures"" or causes a chemical reaction to change the material in a desired fashion. Typical materials are adhesives, plastics, potting compounds, etc.||||N|N
||RGP|Black Light|N||N|N||||An ultraviolet wavelength noncoherent light source used to illuminate a fluorescent material to produce fluorescence.||||N|N
||RGQ|Cosmetology Uv Lamp|N||N|N||||An ultraviolet wavelength noncoherent light source used to irradiate skin, nails, or hair for cosmetic purposes (excluding tanning).||||N|N
||RGS|Water Purifier|N||N|N||||An ultraviolet wavelength noncoherent light source used to sanitize water.||||N|N
||RGT|Spectroscopy, Ultraviolet Fluorescence|N||N|N||||An ultraviolet wavelength noncoherent light source used to stimulate ultraviolet fluorescence.||||N|N
||RGU|X-Ray Field Indicator Light Field (Non-Laser)|N||N|N||||A noncoherent light source incorporated in a diagnostic x-ray system that is irradiated onto the film screen area indicating the x-radiation area.  The beam is usually scanned to show a rectangular region for patient placement.||||N|N
||RGV|Veterinary Optical Product|N||N|N||||A noncoherent light source used in veterinary medicine.||||N|N
||RGW|Uv/Ir Research|N||N|N||||A noncoherent ultraviolet or infrared light source used in research.||||N|N
||RGX|Fluorescent Lamp|N||N|N||||A general purpose fluorescent lamp used for illumination.||||N|N
||RGY|Ir Intrusion Detector|N||N|N||||A noncoherent infrared light source used to detect motion to protect against intrusion.||||N|N
||RGZ|Ir Security|N||N|N||||A noncoherent infrared light source used for security.||||N|N
||RHA|Ir Data Transmit/Control|N||N|N||||A noncoherent infrared source used for data transmission or remote control of another product or machine.||||N|N
||RHB|Tungsten Halogen Lamp|N||N|N||||A tungsten halogen lamp.||||N|N
||RHC|High Pressure Mercury, Metal Halide, And Mercury Xenon Lamp (Not For General Purpose Illumination)|N||N|N||||A high pressure mercury vapor, metal halide, or mercury xenon lamp used for a specific purpose and not intended for general purpose illumination.  Specific examples are lamps used in scientific and industrial equipment, projection televisions and computer projectors, searchlights, etc.||||N|N
||RHD|Ir Remote Controller|N||N|N||||A noncoherent infrared light source used to transmit signals and/or information in order to operate equipment or machinery remotely.||||N|N
||RHF|Digital Display Monitor|N||N|N||||A monitor or projector that uses a high intensity light source to illuminate pixels to produce images driven from a digital image source.||||N|N
||RHG|Light, Spectrum, Broad (Non-Medical)|N||N|N||||A broad spectrum output noncoherent light source intended for general purpose.||||N|N
||RHH|Led Light |N||N|N||||A light-emitting diode source.||||N|N
||RHI|Mercury Vapor Lamp, Not Self-Extinguishing, R-Type|N||N|N||||High intensity mercury vapor discharge lamp, not self-extinguishing, r lamp||||N|N
||RHJ|Television, Less Than 25kv And Less Than 0.1 Mr/Hr|N||N|N||||Television product, less than 25 kilovolt and less than 0.1 milliroentgen per hour||||N|N
||RHK|Laser Marker Or Engraver|N||N|N||||A laser intended to mark or engrave an object with text, logos, etc. Using either a mask or a scanned laser beam.||||N|N
||RHL|Laser Therapy Product|N||N|N||||Non-surgical laser used on parts of the human body for non-medical uses.||||N|N
||RHM|Image Digitizer|N||N|N||||Product, laser, image digitizer; Converts analog image into digital image format.||||N|N
||RHN|Fiber Optic Instrument For Testing Optical Fibers|N||N|N||||A laser used in an instrument for testing and characterizing optical fibers.||||N|N
||RHO|Sound Amplification Product|N||N|N||||Intended to amplify environmental sound for non-hearing impaired consumers||||N|N
||RHP|Uv Lamp, Germicidal|N||N|N||||An ultraviolet wavelength noncoherent light source intended for use in general purpose, germicidal systems.||||N|N
||RHQ|Holographic Displaying Or Creating Laser Product.|N||N|N||||Laser product or product containing a laser that is for the creation or display of holograms for entertainment, artistic, or educational purposes.||||N|N
||RHR|Laser Holographic System For Experiments, Research, Or Prototype Development|N||N|N||||A laser holographic system intended to be used for experimental or research purposes; May be prototypes for later manufacturing||||N|N
||RHS|Laser Holographic System|N||N|N||||A laser holographic system intended for measurement or process control in manufacturing, inspection, diagnosis or similar engineering activities||||N|N
||RHT|Laser Mouse, Trackball, Or Similar|N||N|N||||A mouse or trackball related to a computer or similar electronic tool, used to control the curser on the screen interface.||||N|N
||RHU|L.E.D. Mouse, Trackball, Or Similar|N||N|N||||A mouse or trackball that incorporates a light emitting diode (led) to be used in relation to a computer or similar electronic tool, that controls the curser on the screen interface.||||N|N
||RHV|Metal Deposition Laser Product|N||N|N||||A Laser driven metal deposition system.||||N|N
||RHW|Uv Lamp For Home Or Business Uses|N||N|N||||Uv noncoherent lamp product intended for consumer or commercial use; Including printing, reprographics, and other such processes||||N|N
||RHX|Sodium Vapor Lamp|N||N|N||||A sodium vapor lamp is a gas discharge lamp that uses sodium in an excited state to product light.  There are two varieties of such lamps: Low pressure and high pressure.  It is for general purpose illumination.||||N|N
||RHY|Laser Sensing System|N||N|N||||Laser wavefront sensing and/or topographic measurement sensor system.||||N|N
||RHZ|3d Laser Scanning System|N||N|N||||A 3d laser scanning system to be used in an accurate free form process to capture physical objects and produce a complete digital representation of the object for applications such as reverse engineering, prototyping, design, modeling, or others.||||N|N
||RIA|High Intensity Lamp|N||N|N||||High intensity mercury vapor or metal halide lamp, intended for general purpose illumination, but of such a design that breakage of an outer envelope will not result in increased uv emissions.||||N|N
||RIB|Microscopy Laser Instrument Or Accessory Products|N||N|N||||A laser product for microscopic studies of samples or a microscope laser accessory to assist in such microscopic studies.||||N|N
||RIC|Ultrasonic Cutter|N||N|N||||Equipment used to cut objects in commercial or industrial applications.||||N|N
||RID|Lcd, General Purpose Illumination|N||N|N||||A liquid crystal display (LCD) is a flat panel display that uses the light modulating properties of liquid crystal.||||N|N
||RIE|Visible Laser Illuminator|N||N|N||||Laser product, visible wavelength, illuminator.||||N|N
||RIF|Smart Meter|N||N|N||||An electrical meter that records consumption of a consumable product delivered by a utility company and communicates wirelessly back to the utility company for monitoring and billing purposes.||||N|N
||RIG|Laser Illuminated Projector|N||N|N||||A full-frame digital image projector which incorporates lasers and possibly other light sources to illuminate image processing components.||||N|N
||RIH|Metal Halide Lamp, Other|N||N|N||||Any metal halide lamp, including sodium vapor, that does not incorporate a high-pressure arc discharge tube that has a fill consisting primarily of mercury and that is contained within an outer envelope.||||N|N
||RII|Scientific Optical Instrument, Noncoherent|N||N|N||||Any scientific or research instrument that incorporates or uses any noncoherent light source.||||N|N
||RIJ|Automotive Radar|N||N|N||||A machine that utilizes microwave radiation for object detection and collision avoidance.||||N|N