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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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No Description
Cerner Corporation
PathNet Blood Bank Transfusion 2012
In Commercial Distribution

  • 00853023006098 ()


  • Blood bank information system application software
No Description
Cerner Corporation
PathNet Blood Bank Transfusion2015
In Commercial Distribution

  • 00853023006067 ()


  • Blood bank information system application software
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
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
No Description
EMCYTE CORP.
620-22-10
In Commercial Distribution

  • 00855306003404 ()
620-22-10

  • Haematological concentrate system preparation kit, bone marrow concentration
  • Haematological concentrate system preparation kit, platelet concentration
No Description
EMCYTE CORP.
620-12-02
In Commercial Distribution

  • 00855306003381 ()
620-12-02

  • Haematological concentrate system preparation kit, bone marrow concentration
  • Haematological concentrate system preparation kit, platelet concentration
No Description
EMCYTE CORP.
620-22-09
In Commercial Distribution

  • 00855306003329 ()
620-22-09

  • Haematological concentrate system preparation kit, platelet concentration
  • Haematological concentrate system preparation kit, bone marrow concentration
No Description
EMCYTE CORP.
620-22-08
In Commercial Distribution

  • 00855306003312 ()
620-22-08

  • Haematological concentrate system preparation kit, platelet concentration
  • Haematological concentrate system preparation kit, bone marrow concentration
No Description
EMCYTE CORP.
620-22-07
In Commercial Distribution

  • 00855306003305 ()
620-22-07

  • Haematological concentrate system preparation kit, platelet concentration
  • Haematological concentrate system preparation kit, bone marrow concentration
No Description
EMCYTE CORP.
620-22-06
In Commercial Distribution

  • 00855306003299 ()
620-22-06

  • Haematological concentrate system preparation kit, bone marrow concentration
  • Haematological concentrate system preparation kit, platelet concentration
No Description
EMCYTE CORP.
GS30
In Commercial Distribution

  • 00855306003190 ()
GS30

  • Haematological concentrate system preparation kit, bone marrow concentration
  • Haematological concentrate system preparation kit, platelet concentration
No Description
EMCYTE CORP.
GS60-PURE
In Commercial Distribution

  • 00855306003183 ()
GS60-PURE

  • Haematological concentrate system preparation kit, bone marrow concentration
  • Haematological concentrate system preparation kit, platelet concentration
No Description
EMCYTE CORP.
GS120
In Commercial Distribution

  • 00855306003084 ()
GS120

  • Haematological concentrate system preparation kit, platelet concentration
  • Haematological concentrate system preparation kit, bone marrow concentration
No Description
EMCYTE CORP.
620-11-09
In Commercial Distribution

  • 00855306003053 ()
620-11-09

  • Haematological concentrate system preparation kit, bone marrow concentration
  • Haematological concentrate system preparation kit, platelet concentration
No Description
EMCYTE CORP.
620-11-08
In Commercial Distribution

  • 00855306003046 ()
620-11-08

  • Haematological concentrate system preparation kit, bone marrow concentration
  • Haematological concentrate system preparation kit, platelet concentration
No Description
EMCYTE CORP.
620-11-06
In Commercial Distribution

  • 00855306003039 ()
620-11-06

  • Haematological concentrate system preparation kit, bone marrow concentration
  • Haematological concentrate system preparation kit, platelet concentration
No Description
EMCYTE CORP.
620-11-07
In Commercial Distribution

  • 00855306003022 ()
620-11-07

  • Haematological concentrate system preparation kit, platelet concentration
  • Haematological concentrate system preparation kit, bone marrow concentration
No Description
EMCYTE CORP.
620-11-02
In Commercial Distribution

  • 00855306003015 ()
620-11-02

  • Haematological concentrate system preparation kit, platelet concentration
  • Haematological concentrate system preparation kit, bone marrow concentration
No Description
EMCYTE CORP.
GS60
In Commercial Distribution

  • 00855306003008 ()
GS60

  • Haematological concentrate system preparation kit, bone marrow concentration
  • Haematological concentrate system preparation kit, platelet concentration
The alVeo Autologous Fibrin & Platelet System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
ROYAL BIOLOGICS INC.
510354
In Commercial Distribution

  • 10850014593640 ()
  • 00850014593643 ()

  • Total Volume: 60 Milliliter
510354

  • Haematological concentrate system preparation kit, platelet concentration
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