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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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The Style A, Size 1, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin.
Kestra Medical Technologies, Inc.
80015-001
In Commercial Distribution

  • 00840241600054 ()

  • Style A, Size 1
80015-001

  • Wearable defibrillation system defibrillator
A part of the ASSURE System that provides power and displays system status information
Kestra Medical Technologies, Inc.
80008-003
In Commercial Distribution

  • 00840241600030 ()
80008-003

  • Wearable defibrillation system defibrillator
A separate device that charges the Battery
Kestra Medical Technologies, Inc.
3326633-004
In Commercial Distribution

  • 00840241600016 ()
3326633-004

  • Wearable defibrillation system defibrillator
Liquid Embolic 105-7100-080 Onyx 34
Micro Therapeutics, Inc.
105-7100-080
In Commercial Distribution

  • 00836462005051 ()


  • Neurovascular embolization plug
No Description
Advanced Bionics, LLC
CI-2000
In Commercial Distribution



  • Electrical mains power cable
Curaplex Select Defibrillation Electrode, Cardiac Science , Adult 10pr/CASE
BOUND TREE MEDICAL, LLC
T100-CASE
In Commercial Distribution

  • 00817617029641 ()
  • 00817617029634 ()
16382

  • Electrode conductive skin pad, single-use
No Description
Advanced Bionics, LLC
CI-2000
Not in Commercial Distribution

  • 07630016810411 ()


  • Cochlear implant/auditory brainstem implant battery
No Description
Thoratec Corporation
14815-2568-000
In Commercial Distribution

  • 00813024012238 ()
14815-2568-000

  • Implantable ventricular circulatory assist system inflow cannula, synthetic polymer
No Description
Thoratec Corporation
14116-2564-000
In Commercial Distribution

  • 00813024012221 ()
14116-2564-000

  • Implantable ventricular circulatory assist system inflow cannula, synthetic polymer
No Description
Thoratec Corporation
14114-2572-000
In Commercial Distribution

  • 00813024012214 ()
14114-2572-000

  • Implantable ventricular circulatory assist system inflow cannula, synthetic polymer
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