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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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Autologous Platelet System - PRP X 2
Musculoskeletal Transplant Foundation, Inc.
910047
Not in Commercial Distribution

  • 00859070006029 ()
910047

  • Haematological concentrate system preparation kit, platelet concentration
Autologous Platelet System Membrane
Musculoskeletal Transplant Foundation, Inc.
910044
Not in Commercial Distribution

  • 00859070006012 ()
910044

  • Haematological concentrate system preparation kit, platelet concentration
Autologous Platelet System - RPR
Musculoskeletal Transplant Foundation, Inc.
910046
Not in Commercial Distribution

  • 00859070006005 ()
910046

  • Haematological concentrate system preparation kit, platelet concentration
No Description
VERICEL CORPORATION
366643
In Commercial Distribution

  • 00850037506156 ()


  • Evacuated blood collection tube IVD, anticoagulant
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
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
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