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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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Biowy Freezing Bag FB250, Max Volume: 250 mL
Biowy Corporation
FB250
In Commercial Distribution

  • 00851739007019 ()
  • 00851739007231 ()


  • Blood/tissue storage/culture container
Biowy Freezing Bag FB50, Max Volume: 50 mL
Biowy Corporation
FB50
In Commercial Distribution

  • 00851739007002 ()
  • 00851739007187 ()


  • Blood/tissue storage/culture container
RECELL Autologous Cell Harvesting Device
AVITA MEDICAL AMERICAS, LLC
US 480
In Commercial Distribution

  • 00851707004262 ()
AVRL0102

  • Autologous skin cell grafting kit
RECELL Autologous Cell Harvesting Device
AVITA MEDICAL AMERICAS, LLC
US 1920
In Commercial Distribution

  • 00851707004149 ()
C3RL01-B:US

  • Autologous skin cell grafting kit
Aurix Wound dressing kit single tray with tyvek lidstock label for AGSW-03, 4TR compoonent kit
Nuo Therapeutics, Inc.
AUXP-4TR
In Commercial Distribution

  • 00852714003248 ()


  • Wound dressing kit, medicated
Aurix Reagent Kit Single Kit with 010110 Reagent Kit Label
Nuo Therapeutics, Inc.
AGSR-03
In Commercial Distribution

  • 00852714003118 ()


  • Wound dressing kit, medicated
Aurix Wound Dressing Kit Single Unit (Kit or Tray) with 010364 Tyvek Lidstock Label for AGSW-02
Nuo Therapeutics, Inc.
AGSW-02
In Commercial Distribution

  • 00852714003101 ()


  • Wound dressing kit, medicated
Aurix Centrifuge with 010463 Aurix Centrifuge Machine Registration Label
Nuo Therapeutics, Inc.
AGSC-04
In Commercial Distribution

  • 00852714003095 ()


  • General-purpose centrifuge IVD
Plasma Thawing System
CYTOTHERM LP
CT-D1
In Commercial Distribution

  • 00861128000354 ()


  • Cryopreserved blood/tissue thawing unit
Plasma Thawing System
CYTOTHERM LP
CT-DR
In Commercial Distribution

  • 00861128000347 ()


  • Cryopreserved blood/tissue thawing unit
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