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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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Regulated Software Application (RSA), Version 2.0 is a stand-alone blood establishment computer software application (BECS) that provides management controls and information services that have been designed to assist personnel in the operation of a blood center.
ARC-ONE SOLUTIONS, LLC
2.0.0.0
In Commercial Distribution

  • 00860006793708 ()
2.0.0.0

  • Blood bank information system application software
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
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
30mL Platelet Rich Plasma production device
Bellus Medical, LLC
P5PG020
Not in Commercial Distribution

  • 00850060751165 ()
  • 00850060751141 ()
  • 10850060751162 ()


  • Autologous platelet-based product centrifuge tube
15mL Platelet Rich Plasma production device
Bellus Medical, LLC
P5PG052
In Commercial Distribution

  • 00850060751134 ()
  • 00850060751110 ()
  • 10850060751131 ()
  • 00850060751196 ()
PROGEN-A15

  • Autologous platelet-based product centrifuge tube
15 mL Platelet Rich Plasma production device
Bellus Medical, LLC
P5PG019
Not in Commercial Distribution

  • 00850060751127 ()
  • 00850060751103 ()
  • 10850060751124 ()


  • Autologous platelet-based product centrifuge tube
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
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