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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 - 00851739007019

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

  • 00851739007019 ()
  • 00851739007231 ()


  • Blood/tissue storage/culture container

Biowy Freezing Bag - 00851739007002

Biowy Freezing Bag FB50, Max Volume: 50 mL
Biowy Corporation
FB50
In Commercial Distribution

  • 00851739007002 ()
  • 00851739007187 ()


  • Blood/tissue storage/culture container

RECELL - 00851707004262

RECELL Autologous Cell Harvesting Device
AVITA MEDICAL AMERICAS, LLC
US 480
In Commercial Distribution

  • 00851707004262 ()
AVRL0102

  • Autologous skin cell grafting kit

RECELL - 00851707004149

RECELL Autologous Cell Harvesting Device
AVITA MEDICAL AMERICAS, LLC
US 1920
In Commercial Distribution

  • 00851707004149 ()
C3RL01-B:US

  • Autologous skin cell grafting kit

Accelerate PRP-G 60mL GenesisCS Component Concentrating System - 00855306003404

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

Accelerate II Platelet Concentrating System 60mL - 00855306003381

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

Accelerate II Platelet Concentrating System PRP-S 60mL - 00855306003329

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

Accelerate II Platelet Concentrating System PRP-S 60mL - 00855306003312

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

Accelerate II Platelet Concentrating System PRP-S 30mL - 00855306003305

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

Accelerate II Platelet Concentrating System PRP-S 30mL - 00855306003299

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
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