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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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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

Virtue CPKit - 04719875912177

No Description
AEON BIOTHERAPEUTICS CORP.
ABA-15Q
In Commercial Distribution

  • 04719875912177 ()


  • Haematological concentrate system preparation kit, platelet concentration

Virtue CPKit - 04719875912160

No Description
AEON BIOTHERAPEUTICS CORP.
ABA-15S
In Commercial Distribution

  • 04719875912160 ()


  • Haematological concentrate system preparation kit, platelet concentration

Virtue CPKit - 04719875912153

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

  • 04719875912153 ()


  • Haematological concentrate system preparation kit, platelet concentration

Virtue CPKit - 04719875912146

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

  • 04719875912146 ()


  • Haematological concentrate system preparation kit, platelet concentration

Virtue CPKit - 04719875912139

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

  • 04719875912139 ()


  • Haematological concentrate system preparation kit, platelet concentration

Virtue CPKit - 04719875912122

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

  • 04719875912122 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912054

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

  • 04719875912054 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912047

No Description
AEON BIOTHERAPEUTICS CORP.
ABA-15Q
In Commercial Distribution

  • 04719875912047 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912030

No Description
AEON BIOTHERAPEUTICS CORP.
ABA-15S
In Commercial Distribution

  • 04719875912030 ()


  • Haematological concentrate system preparation kit, platelet concentration

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

Briostor™ Transfer/Freezing Bag Set - 00636207314680

Five Chamber Transfer/Freezing Bag Set intended to be used for cord blood processing and freezing
Global Life Sciences Solutions USA LLC
791-12
In Commercial Distribution

  • 30636207314681 ()
  • 00636207314680 ()

  • Five chamber transfer/freezing bag
791-12

  • Umbilical cord blood collection set

Pall® Freezing Bag 25 mL with Separable Chamber - 00636207302465

25 mL Freezing Bag with Separable Chamber for blood component freezing.
Global Life Sciences Solutions USA LLC
791-05
In Commercial Distribution

  • 30636207302466 ()
  • 00636207302465 ()
  • 20636207302469 ()

  • Total Volume: 25 Milliliter
  • recommended fill volume
791-05

  • Umbilical cord blood collection set

Pall® Transfer/Freezing Bag Set - 00636207302441

Two transfer bags (150 mL and 200 mL) and one 25 mL freezing bag for blood component processing and freezing.
Global Life Sciences Solutions USA LLC
791-02
In Commercial Distribution

  • 30636207302442 ()
  • 00636207302441 ()

  • Total Volume: 25 Milliliter
  • recommended fill volume
791-02

  • Umbilical cord blood collection set

Pall® CellWash/Infusion Bag Set - 00636207302434

Two empty transfer bags with two spikes and luer adapter and associated tubing for washing blood and cellular components.
Global Life Sciences Solutions USA LLC
791-03
In Commercial Distribution

  • 30636207302435 ()
  • 00636207302434 ()

  • Total Volume: 250 Milliliter
  • maximum 250 mL fill volume per bag
791-03

  • Umbilical cord blood collection set

SampLok® Sampling Kit 16mL - 09555240405616

SSK 16mL is a device used to transfer sample from bllod bags or other containers with sterile docking compatible tubing to vacuum containers for in-vitro tests. Single use only. The device is for use by trained laboratory staff, in a laboratory
ITL ASIA PACIFIC SDN. BHD.
A100756
In Commercial Distribution

  • 19555240405613 ()
  • 09555240405616 ()
A100756

  • Blood/blood culture specimen transfer spike IVD, manual

SampLok® Sampling Kit 35mL - 09555240403865

SampLok® Sampling Kit (SSK): SSK-Mk3-35mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.
ITL ASIA PACIFIC SDN. BHD.
A100752
Not in Commercial Distribution

  • 19555240403862 ()
  • 09555240403865 ()
A100752

  • Blood/blood culture specimen transfer spike IVD, manual

SampLok® Sampling Kit 10mL - 09555240400734

SampLok® Sampling Kit (SSK): SSK-Mk3-10mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.
ITL ASIA PACIFIC SDN. BHD.
A100750
In Commercial Distribution

  • 19555240400731 ()
  • 09555240400734 ()
A100750

  • Blood/blood culture specimen transfer spike IVD, manual

SampLok® Sampling Kit 16mL - 09555240400536

SampLok® Sampling Kit (SSK): SSK-Mk2-16mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.
ITL ASIA PACIFIC SDN. BHD.
A100740
In Commercial Distribution

  • 19555240400533 ()
  • 09555240400536 ()
A100740

  • Blood/blood culture specimen transfer spike IVD, manual
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