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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
Mobile application used by patients for disease management
Takeda Pharmaceuticals U.S.A., Inc.
V2
In Commercial Distribution

  • 00850025688826 ()


  • Home pharmaceutical management support software
Web application used by Healthcare Professionals to generate dose calculations
Takeda Pharmaceuticals U.S.A., Inc.
V3
In Commercial Distribution

  • 00850025688819 ()


  • Home pharmaceutical management support software
No Description
VERICEL CORPORATION
366643
In Commercial Distribution

  • 00850037506156 ()


  • Evacuated blood collection tube IVD, anticoagulant
The CompoDock is used for the production of special cellular blood components, e.g. in blood banks where tube connections are needed that provide protection against microbial contamination. The CompoDock is a high-frequency connection device that permits sterile connection of medical PVC tubes to one another. Here, sterile connection is achieved when germs from the environment are prevented from being carried into the closed systems. The closed system is maintained after the docking process.
Fresenius Kabi AG
9028721
In Commercial Distribution

  • 04086000860215 ()
9028721

  • Laboratory tubing welder
DXT is intended to be used in blood establishments to facilitate networked communication between DXT compatible Fresenius Kabi apheresis devices and BECS or other Data Management Systems.
Fresenius Kabi AG
3.0
In Commercial Distribution

  • 04086000101578 ()
X6S9830, X6S9830USB

  • Blood bank information system application software
For Collection of Plasma by Membrane Filtration. For Use with the AUTOPHERESIS-C Instrument. Sterile Fluid Path.
Fresenius Kabi AG
4R2252
In Commercial Distribution

  • 04086000101455 ()
  • 14086000101452 ()
4R2252

  • Apheresis system tubing set
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