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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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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
Eclipse PRP HC Patient Kit - 22ml PRP Tube Only (International)
ECLIPSE
PRP2000-1.Intl
In Commercial Distribution

  • 00853602008093 ()

  • Weight: 123.8 Gram
  • Depth: 1.125 Inch
  • Width: 6.938 Inch
  • Height: 3.125 Inch
PRP2000-1.Intl

  • Haematological concentrate system
Blood separation tube for PRP
Factor Medical, Inc.
0363
In Commercial Distribution

  • 00851802007113 ()

  • Total Volume: 9 Milliliter
0363

  • Haematological concentrate system preparation kit, platelet concentration
Biowy Freezing Bag FB1000, Max Volume: 1000 mL
Biowy Corporation
FB1000
In Commercial Distribution

  • 00851739007255 ()
  • 00851739007033 ()


  • Blood/tissue storage/culture container
Biowy Freezing Bag FB500, Max Volume: 500 mL
Biowy Corporation
FB500
In Commercial Distribution

  • 00851739007248 ()
  • 00851739007026 ()


  • Blood/tissue storage/culture container
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
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