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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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3-Ncc947 Weld Integrity Test Kit
TERUMO BCT, INC.
3NCC947
In Commercial Distribution

  • 05020583300064 ()


  • Package sealing unit
Weld Integrity Test Kit
TERUMO BCT, INC.
3NCC945
In Commercial Distribution

  • 05020583300040 ()


  • Package sealing unit
Sterile Tubing Welder
TERUMO BCT, INC.
3MESC203A
In Commercial Distribution

  • 05020583300033 ()


  • Package sealing unit
SCD II Final Assembly
TERUMO BCT, INC.
3NCC986
In Commercial Distribution

  • 05020583300026 ()


  • Package sealing unit
TOMEs Terumo Operational Medical Equipment Software Version 7.3
TERUMO BCT, INC.
11401
In Commercial Distribution

  • 05020583114012 ()
11401

  • Blood bank information system application software
IDL Set
TERUMO BCT, INC.
10300
In Commercial Distribution

  • 05020583103009 ()
  • 35020583103000 ()


  • Blood transfer set
CHIV QC Kit Atellica IM - CLT 5 x 1 x 15.0mL
Siemens Healthcare Diagnostics Inc.
10995528
In Commercial Distribution

  • 00630414598550 ()
10995528

  • HIV1/HIV2 antigen/antibody IVD, control
ADVIA Centaur® CHIV Quality Control Material
Siemens Healthcare Diagnostics Inc.
10697214
In Commercial Distribution

  • 00630414590202 ()
10697214

  • HIV1/HIV2 antigen/antibody IVD, control
ADVIA Centaur® CHIV assay (100 tests)
Siemens Healthcare Diagnostics Inc.
10696880
In Commercial Distribution

  • 00630414589749 ()
10696880

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
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
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