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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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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
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
The Regulated Software Application (RSA) is a system of co-dependent web based computer programs, used to manage and support all aspects of the blood banking process.
ARC-ONE SOLUTIONS, LLC
1.0.33.0
Not in Commercial Distribution

  • 00860003545409 ()
1.0.33.0

  • Blood bank information system application software
30mL Platelet Rich Plasma production device
Bellus Medical, LLC
P5PG053
In Commercial Distribution

  • 00850060751172 ()
  • 00850060751158 ()
  • 10850060751179 ()
  • 00850060751202 ()
PROGEN-A30

  • Autologous platelet-based product centrifuge tube
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