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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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GS - 00847865013253

GS HIV Combo Ag/Ab EIA, Conjugate 2 Diluent, 40 mL
Bio-RAD Laboratories, Inc.
26228
In Commercial Distribution

  • 00847865013253 ()

  • Total Volume: 40 Milliliter
26228

  • HIV1/HIV2 antigen/antibody IVD, reagent

GS - 00847865013246

GS HIV Combo Ag/Ab EIA, Conjugate 2, Lyophilized, 40 mL
Bio-RAD Laboratories, Inc.
26227
In Commercial Distribution

  • 00847865013246 ()

  • Total Volume: 40 Milliliter
26227

  • HIV1/HIV2 antigen/antibody IVD, reagent

GS - 00847865013239

GS HIV Combo Ag/Ab EIA, Conjugate 2, Lyophilized, 18 mL
Bio-RAD Laboratories, Inc.
26226
In Commercial Distribution

  • 00847865013239 ()

  • Total Volume: 18 Milliliter
26226

  • HIV1/HIV2 antigen/antibody IVD, reagent

GS - 00847865013222

GS HIV Combo Ag/Ab EIA, Conjugate 1, 10 mL
Bio-RAD Laboratories, Inc.
26225
In Commercial Distribution

  • 00847865013222 ()

  • Total Volume: 10 Milliliter
26225

  • HIV1/HIV2 antigen/antibody IVD, reagent

GS - 00847865013215

GS HIV Combo Ag/Ab EIA, Cutoff Calibrator, 1.7 mL
Bio-RAD Laboratories, Inc.
26224
In Commercial Distribution

  • 00847865013215 ()

  • Total Volume: 1.7 Milliliter
26224

  • HIV1/HIV2 antigen/antibody IVD, calibrator

GS - 00847865013208

GS HIV Combo Ag/Ab EIA, HIV-2/O Ab Pos Ctrl, 1.5 mL
Bio-RAD Laboratories, Inc.
26222
In Commercial Distribution

  • 00847865013208 ()

  • Total Volume: 1.5 Milliliter
26222

  • HIV1/HIV2 antigen/antibody IVD, control

GS - 00847865013192

GS HIV Combo Ag/Ab EIA, HIV-1 Ab Pos Ctrl, 1.5 mL
Bio-RAD Laboratories, Inc.
26221
In Commercial Distribution

  • 00847865013192 ()

  • Total Volume: 1.5 Milliliter
26221

  • HIV1/HIV2 antigen/antibody IVD, control

GS - 00847865013185

GS HIV Combo Ag/Ab EIA, Negative Control, 1.5 mL
Bio-RAD Laboratories, Inc.
26220
In Commercial Distribution

  • 00847865013185 ()

  • Total Volume: 1.5 Milliliter
26220

  • HIV1/HIV2 antigen/antibody IVD, control

GS - 00847865010672

GS HIV Combo Ag/Ab EIA, HIV Ag Pos Ctrl, 1.5 mL
Bio-RAD Laboratories, Inc.
26223
In Commercial Distribution

  • 00847865010672 ()

  • Total Volume: 1.5 Milliliter
26223

  • HIV1/HIV2 antigen/antibody IVD, control

Bio-Rad - 00847865002745

MULTISPOT HIV-1/HIV-2 Rapid Test 50 Tests
Bio-RAD Laboratories, Inc.
25228
Not in Commercial Distribution

  • 00847865002745 ()

  • 50 Tests
25228

  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

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 - 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 - 00847236015817

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

  • 00847236015817 ()


  • Haematological concentrate system

BioHorizons - 00847236015978

Xpression Box
BIOHORIZONS IMPLANT SYSTEMS, INC
CTRZ
In Commercial Distribution

  • 00847236015978 ()
  • 00847236019822 ()


  • Haematological concentrate system

BioHorizons - 00847236015824

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

  • 00847236015824 ()


  • 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

Puriblood - 04719878520515

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-08-PS
In Commercial Distribution

  • 14719878520512 ()
  • 04719878520515 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520508

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-07-PS
In Commercial Distribution

  • 14719878520505 ()
  • 04719878520508 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520492

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-06-PS
In Commercial Distribution

  • 14719878520499 ()
  • 04719878520492 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520485

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-05-PS
In Commercial Distribution

  • 14719878520482 ()
  • 04719878520485 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520478

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-04-PS
In Commercial Distribution

  • 14719878520475 ()
  • 04719878520478 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520461

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-01-PS
In Commercial Distribution

  • 14719878520468 ()
  • 04719878520461 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520003

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-12-PS
In Commercial Distribution

  • 04719878520003 ()
  • 14719878520000 ()


  • Blood transfusion set, non-exchange
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