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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-PRFM x 2
Musculoskeletal Transplant Foundation, Inc.
910048
Not in Commercial Distribution

  • 00859070006043 ()
910048

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

  • 00859070006005 ()
910046

  • Haematological concentrate system preparation kit, platelet concentration
This is the outer label for the box that includes 12 3C Patch® Kits and the IFU.
Reapplix ApS
2
In Commercial Distribution

  • 05714188505503 ()


  • Haematological concentrate system preparation kit, platelet concentration
This is the retail bag label for the retail bag, which contains 6 venipuncture needle sets (commercially available) and 6 3C Patch Needle Holders.
Reapplix ApS
2
In Commercial Distribution

  • 05714188505206 ()


  • Haematological concentrate system preparation kit, platelet concentration
Kit that includes 3C Patch Device, 3C Patch Needle Holder, Venipuncture Needle Set (commercially available), Skin Preparation Alcohol Swab (commercially available), Post-Sampling Adhesive Bandage (band aid) (commercially available), and Primary Wound Cover Dressing (commercially available).
Reapplix ApS
2
In Commercial Distribution

  • 05714188505008 ()


  • Haematological concentrate system preparation kit, platelet concentration
Holds the blood at collection and during processing in the centrifuge.
Reapplix ApS
2
In Commercial Distribution

  • 05714188502106 ()


  • Haematological concentrate system preparation kit, platelet concentration
Used to attach and hold the 3C Patch Device with the supplied venipuncture set.
Reapplix ApS
2
In Commercial Distribution

  • 05714188501000 ()


  • Haematological concentrate system preparation kit, platelet concentration
PK7300
Beckman Coulter, Inc.
N3209000
In Commercial Distribution

  • 14987666535721 ()
N3209000

  • Blood group/antibody screening analyser IVD
24 Tests with support materials
Biolytical Laboratories Inc
With Support
Not in Commercial Distribution

  • 06865979010184 ()
90-1018

  • HIV1/HIV2 antigen IVD, kit, rapid ICT, clinical
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