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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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Aeon CPKit - 04719875912023

No Description
AEON BIOTHERAPEUTICS CORP.
APA-10G
In Commercial Distribution

  • 04719875912023 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912016

No Description
AEON BIOTHERAPEUTICS CORP.
APA-15G
In Commercial Distribution

  • 04719875912016 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912009

No Description
AEON BIOTHERAPEUTICS CORP.
APA-15
In Commercial Distribution

  • 04719875912009 ()


  • Haematological concentrate system preparation kit, platelet concentration

BioHorizons - 00847236016043

IntraSpin System 220V, Procedure Pack
BIOHORIZONS IMPLANT SYSTEMS, INC
LPRF220
In Commercial Distribution

  • 00847236016043 ()


  • Haematological concentrate system

BioHorizons - 00847236016036

IntraSpin System 110V, Procedure Pack
BIOHORIZONS IMPLANT SYSTEMS, INC
LPRF110
In Commercial Distribution

  • 00847236016036 ()


  • Haematological concentrate system

BioHorizons - 00847236015978

Xpression Box
BIOHORIZONS IMPLANT SYSTEMS, INC
CTRZ
In Commercial Distribution

  • 00847236015978 ()
  • 00847236019822 ()


  • Haematological concentrate system

BioHorizons - 00847236015893

IntraSpin Tube Holder Replacement
BIOHORIZONS IMPLANT SYSTEMS, INC
BTUBEHOLDZ
In Commercial Distribution

  • 00847236015893 ()


  • Centrifuge bucket/tube holder

BioHorizons - 00847236015886

IntraSpin Rotor, 110v & 220v
BIOHORIZONS IMPLANT SYSTEMS, INC
BROTORZ
In Commercial Distribution

  • 00847236015886 ()


  • Centrifuge rotor, ultracentrifuge

BioHorizons - 00847236015879

IntraSpin Power Cord, 220v
BIOHORIZONS IMPLANT SYSTEMS, INC
BPOWER220Z
In Commercial Distribution

  • 00847236015879 ()


  • Electrical mains power cable

BioHorizons - 00847236015862

IntraSpin Power Cord, 110v
BIOHORIZONS IMPLANT SYSTEMS, INC
BPOWER110Z
In Commercial Distribution

  • 00847236015862 ()


  • Electrical mains power cable

BioHorizons - 00847236015855

IntraSpin Hex Key, 110v & 220v
BIOHORIZONS IMPLANT SYSTEMS, INC
BHEXZ
In Commercial Distribution

  • 00847236015855 ()


  • Haematological concentrate system

BioHorizons - 00847236015848

IntraSpin Fuse 220v
BIOHORIZONS IMPLANT SYSTEMS, INC
BFUSE220Z
In Commercial Distribution

  • 00847236015848 ()


  • Haematological concentrate system

BioHorizons - 00847236015831

IntraSpin Fuse 110v
BIOHORIZONS IMPLANT SYSTEMS, INC
BFUSE110Z
In Commercial Distribution

  • 00847236015831 ()


  • Haematological concentrate system

BioHorizons - 00847236015824

IntraSpin Centrifuge, 220 volts
BIOHORIZONS IMPLANT SYSTEMS, INC
IS220Z
In Commercial Distribution

  • 00847236015824 ()


  • Haematological concentrate system

BioHorizons - 00847236015817

IntraSpin Centrifuge, 110 volts
BIOHORIZONS IMPLANT SYSTEMS, INC
IS110Z
In Commercial Distribution

  • 00847236015817 ()


  • Haematological concentrate system

TransCyte - 00618474000046

TRANSCYTE® is a human fibroblast-derived temporary skin substitute consisting of a polymer membrane and donated neonatal human fibroblast cells cultured under aseptic conditions in vitro on a nylon mesh. Prior to cell growth, this nylon mesh is coated with porcine dermal collagen and bonded to a polymer membrane (silicone). This membrane provides a transparent synthetic epidermis when applied. As fibroblasts proliferate within the nylon mesh, they secrete human dermal collagen, matrix proteins and growth factors. Following freezing, no cellular metabolic activity remains; however, the tissue matrix and bound growth factors are left intact. The human fibroblast-derived temporary skin substitute provides a temporary protective barrier. TRANSCYTE is transparent and allows direct visual monitoring of the wound bed.
ORGANOGENESIS INC.
10633
In Commercial Distribution

  • 00618474000046 ()


  • Skin regeneration template, human-/animal-derived

MicroAire® - 00847399017352

LIPOFILTER - CLINICAL PACK WITHOUT SYRINGE
Microaire Surgical Instruments LLC
ASP-CAN-NT
In Commercial Distribution

  • 00847399017352 ()


  • Liposuction system

MicroAire® - 00847399015884

LIPOFILTER - CLINICAL PACK
Microaire Surgical Instruments LLC
ASP-CAN-2S
In Commercial Distribution

  • 00847399015884 ()


  • Liposuction system

MicroAire® - 00847399006431

NEEDLE ADAPTER, TOOMEY TO LUER
Microaire Surgical Instruments LLC
ASP-ADP-3
In Commercial Distribution

  • 00847399006431 ()


  • Collection syringe adaptor, single-use

MicroAire® - 00847399006424

SYRINGE ADAPTER, TOOMEY TO LUER
Microaire Surgical Instruments LLC
ASP-ADP-2
In Commercial Distribution

  • 00847399006424 ()


  • Collection syringe adaptor, single-use

AlVeo - 00850014593643

The alVeo 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.
510354
In Commercial Distribution

  • 10850014593640 ()
  • 00850014593643 ()

  • Total Volume: 60 Milliliter
510354

  • Haematological concentrate system preparation kit, platelet concentration

SeriVium - 00850014593636

The SeriVium 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.
510355
In Commercial Distribution

  • 10850014593633 ()
  • 00850014593636 ()

  • Total Volume: 60 Milliliter
510355

  • Haematological concentrate system preparation kit, platelet concentration

BioIncyte - 00850014593629

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

MAXX BMC - 00850014593391

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

MAXX - 00850014593384

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

MAXX PRP - 00850014593377

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

NA - 00869202000214

No Description
MEDHOST OF TENNESSEE, INC.
9.0
In Commercial Distribution

  • 00869202000214 ()


  • Blood bank information system application software

Regulated Software Application (RSA) - 00860003545409

The Regulated Software Application (RSA) is a system of co-dependent web based computer programs, used to manage and support all aspects of the blood banking process.
ARC-ONE SOLUTIONS, LLC
1.0.33.0
Not in Commercial Distribution

  • 00860003545409 ()
1.0.33.0

  • Blood bank information system application software

Blood Product Questionnaire Module - 00860010651209

The Blood Product Questionnaire Module supports single and/or multi-site blood establishment collection facilities’ creation of a donor history questionnaire, the collection of donor history by donors, the determination of visit requirements, and the determination of donor eligibility through system logic or via analysis by trained facility staff members
BUOY SOFTWARE, LLC
1
In Commercial Distribution

  • 00860010651209 ()


  • Blood bank information system application software

SDNet Configurable Manual Batch Entry - 00860010612866

Configurable Software for managing manually entered blood test results.
Rubin & Poor, Inc.
CTS 1.5A
In Commercial Distribution

  • 00860010612866 ()
4

  • Blood bank information system application software

SDNet Configurable Manual Batch Entry - 00860010612859

Configurable software for managing manually entered blood test results.
Rubin & Poor, Inc.
QTX - V1.1a(WinSQL 1.0c)
In Commercial Distribution

  • 00860010612859 ()
6

  • Blood bank information system application software

SDNet Configurable Laboratory Result Manager - 00860010612842

Configurable software for managing automated blood test results.
Rubin & Poor, Inc.
QTX - V1.0e(WinSQL 1.0d)
In Commercial Distribution

  • 00860010612842 ()
5

  • Blood bank information system application software

SDNet Configurable Manual Batch Entry - 00860010612835

Configurable Software for managing manually entered blood test results.
Rubin & Poor, Inc.
CTS 1.4A
In Commercial Distribution

  • 00860010612835 ()
4

  • Blood bank information system application software

SDNet Configurable Laboratory Result Manager - 00860010612828

Configurable software for managing automated blood test results.
Rubin & Poor, Inc.
CTS 1.4A
In Commercial Distribution

  • 00860010612828 ()
3

  • Blood bank information system application software

SDNet Configurable Manual Batch Entry - 00860010612811

Configurable software for managing manually entered blood test results.
Rubin & Poor, Inc.
MBC 1.0B
In Commercial Distribution

  • 00860010612811 ()
2

  • Blood bank information system application software

SDNet Configurable Laboratory Result Manager - 00860010612804

Configurable software for managing automated blood test results.
Rubin & Poor, Inc.
MBC 1.0B
In Commercial Distribution

  • 00860010612804 ()
1

  • Blood bank information system application software

BBCS Lab Interface Application V5.0 - 00860009119482

No Description
Blood Bank Computer System
5.0
In Commercial Distribution

  • 00860009119482 ()


  • Blood bank information system application software

BBCS Hospital Interface Application - 00860009119468

No Description
Blood Bank Computer System
1.0.0
In Commercial Distribution

  • 00860009119468 ()


  • Blood bank information system application software

BBCS BloodTrack Interface Application - 00860009119451

No Description
Blood Bank Computer System
1.0.0
In Commercial Distribution

  • 00860009119451 ()


  • Blood bank information system application software

ABO QuickPass V 1.0.0 - 00860009119444

ABO QuickPass is a software application intended to allow donors to complete Computer Assisted Self Interviews (CASI) and computer assisted blood donor registrations. ABO QuickPass works in tandem with compatible blood bank systems to identify repeat donors, retrieve the donor’s donation eligibility, and retrieve the donor history questionnaire appropriate for the donor and intended donation. Upon completion of ABO QuickPass all information which is entered by the donor is transferred to compatible blood bank systems. CASIs can be completed using the Internet via the ABO QuickPass web portal or at the donor site via the ABO QuickPass kiosk. CASIs which are completed via the web portal produce an encrypted barcode, which can be decrypted and imported on the day of donation into the ABO QuickPass kiosk for transfer of question responses to the facilities compatible blood bank system
Blood Bank Computer System
1.0.0
In Commercial Distribution

  • 00860009119444 ()


  • Blood bank information system application software
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