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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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The BioIncyte Autologous Fibrin & Platelet System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
ROYAL BIOLOGICS INC.
510356
In Commercial Distribution

  • 10850014593626 ()
  • 00850014593629 ()

  • Total Volume: 60 Milliliter
510356

  • Haematological concentrate system preparation kit, platelet concentration
The Royal MAXX™ BMC concentration system is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of a mixture of peripheral blood and bone marrow aspirate at the patient’s point of care for mixing with autograft and/or allograft bone to improve handling characteristics. The system consists of a kit of consumables including a concentration device, syringes, blunt needle, alcohol wipes, ACD-A anticoagulant, and bone marrow aspiration supplies.
ROYAL BIOLOGICS INC.
MXBMC-60
In Commercial Distribution

  • 00850014593391 ()
  • 10850014593398 ()

  • Total Volume: 60 Milliliter
MXBMC-60

  • Haematological concentrate system preparation kit, platelet concentration
The Royal MAXX™ Accessory Kit is designed for use with the Royal MAXX™ PRP and BMC concentration systems. The kit contains 2 reuseable Royal MAXX Counterbalances and 2 reuseable Turn keys .
ROYAL BIOLOGICS INC.
MXCB
In Commercial Distribution

  • 10850014593381 ()
  • 00850014593384 ()

  • Total Volume: 60 Milliliter
MXCB-1

  • Haematological concentrate system preparation kit, platelet concentration
The Royal MAXX™ PRP concentration system is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care for mixing with autograft and/or allograft bone to improve handling characteristics. The system consists of a kit of consumables including a concentration device, syringes, blunt needle, alcohol wipes, ACD-A anticoagulant, and phlebotomy supplies.
ROYAL BIOLOGICS INC.
MXPRP
In Commercial Distribution

  • 10850014593374 ()
  • 00850014593377 ()

  • Total Volume: 60 Milliliter
MXPRP-1

  • Haematological concentrate system preparation kit, platelet concentration
15ML Platelet Rich Plasma production device.
Bimini Technologies LLC
530101-1
In Commercial Distribution

  • 00850034511955 ()
  • 00850034511948 ()


  • 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
HEALPRP30
In Commercial Distribution

  • 00850034511832 ()


  • 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
HEALPRP30
In Commercial Distribution

  • 00850034511443 ()
  • 00850034511580 ()


  • Haematological concentrate system
A sterile, single use, syringe assembly that is intended for separating and concentrating blood components along with the use of a desktop centrifuge. It enables blood to be separated and aspirated in a single device after they have been centrifuged.
Bimini Technologies LLC
GAAPS-25
In Commercial Distribution

  • 00850034511900 ()
  • 00850034511269 ()


  • Haematological concentrate system preparation kit, platelet concentration
Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 (HIV-1, HIV-2)
Biolytical Laboratories Inc
90-1019
In Commercial Distribution

  • 00686597010198 ()
90-1019

  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
No Description
Roche Molecular Systems, Inc.
09040536190
In Commercial Distribution

  • 00875197006483 ()
09040536190

  • HIV1/HIV2 nucleic acid IVD, control
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