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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Eversense Sensor Kit contains one Eversense Sensor.
SENSEONICS, INCORPORATED
FG-4201-00-301
Not in Commercial Distribution

  • 00817491022356 ()
FG-4201-00-301

  • Implantable glucose monitoring system sensor
Eversense Sensor Kit contains one Eversense Sensor.
SENSEONICS, INCORPORATED
FG-4200-00-301
Not in Commercial Distribution

  • 00817491022349 ()
FG-4200-00-301

  • Implantable glucose monitoring system sensor
Eversense Sensor Kit contains one Eversense Sensor.
SENSEONICS, INCORPORATED
FG-4201-00-301
Not in Commercial Distribution

  • 00817491021427 ()
FG-4201-00-301

  • Implantable glucose monitoring system sensor
Eversense Sensor Kit contains one Eversense Sensor.
SENSEONICS, INCORPORATED
FG-4200-00-301
Not in Commercial Distribution

  • 00817491021410 ()
FG-4200-00-301

  • Implantable glucose monitoring system sensor
OBALON® Navigation Balloon System - contains one OBALON® Navigation Balloon Kit and one OBALON® Accessory Kit - Ejectors
Reshape Lifesciences Inc.
9410-0001
Not in Commercial Distribution

  • 10859810006224 ()
  • 00859810006227 ()


  • Appetite-suppression gastric balloon deployment device/set
  • Appetite-suppression gastric balloon
Occluder, Internal Vessel, Temporary
GENZYME CORPORATION
LG250
Not in Commercial Distribution

  • 20358468019046 ()

  • one 2.5 mL syringe with 1 cannula (3.0 x 80 mm)
  • Total Volume: 2.5 Milliliter


  • Intravascular occluding solution kit
OBALON Touch™ Dispenser Kit - contains one OBALON Touch™ Dispenser, one OBALON® Balloon Evacuator, 1 Screwdriver, and Batteries
Reshape Lifesciences Inc.
9300-0001
Not in Commercial Distribution

  • 00859810006203 ()


  • Appetite-suppression gastric balloon inflation regulator
  • Appetite-suppression gastric balloon deployment device/set
PEDI*PADZ® II PEDIATRIC MULTI-FUNCTION ELECTRODES - ONE PAIR
Zoll Medical Corporation
8900-0810-01
In Commercial Distribution

  • 00847946001438 ()
  • 10847946001435 ()

  • 8.4" X 8.1" X 1.0"


  • Rechargeable professional automated external defibrillator
The ResQCPR system contains two ResQPODs and one ResQPump
ADVANCED CIRCULATORY SYSTEMS INC
12-0825-000
In Commercial Distribution

  • M5921208220000 ()
  • M5921208250001 ()
  • M5921208230001 ()


  • Cardiac resuscitator, manual
Contents:one 1 g tube n-BCA with self-piercing luer cap one 1 g vial Ta Powder one 10 mL vial Ethiodized Oil
Cerenovus, Inc.
631-500
In Commercial Distribution

  • 10886704029151 ()
631500

  • Neurovascular embolization plug
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