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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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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
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
For Sampling of Collected Blood and Blood Components. For Laboratory Testing Only. Sterile Fluid Path.
Fresenius Kabi AG
4R2335H
In Commercial Distribution

  • 14086000101421 ()
  • 04086000101424 ()
  • 24086000101428 ()
4R2335H

  • Blood transfer set
30ML Platelet Rich Plasma production device.
Bimini Technologies LLC
530102-1
In Commercial Distribution

  • 00850034511979 ()
  • 00850034511962 ()


  • Haematological concentrate system
A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.
Bimini Technologies LLC
HEALPRP15
In Commercial Distribution

  • 00850034511429 ()
  • 00850034511597 ()


  • Haematological concentrate system
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