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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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Copy Control 4q12 Green - 00847627000248

No Description
BIOCARE MEDICAL LLC
HFA7168A
In Commercial Distribution

  • 00847627000248 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 3 Aqua - 00847627000231

No Description
BIOCARE MEDICAL LLC
HFA7164A
In Commercial Distribution

  • 00847627000231 ()


  • Nucleic acid hybridization detection IVD, probe

5p15.2 Red - 00847627000224

No Description
BIOCARE MEDICAL LLC
CFA7251X
In Commercial Distribution

  • 00847627000224 ()


  • Nucleic acid hybridization detection IVD, probe

5p15.2 Red - 00847627000217

No Description
BIOCARE MEDICAL LLC
CFA7251A
In Commercial Distribution

  • 00847627000217 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 10 Green - 00847627000200

No Description
BIOCARE MEDICAL LLC
CFA7200A
In Commercial Distribution

  • 00847627000200 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 7 Gold - 00847627000194

No Description
BIOCARE MEDICAL LLC
CFA7188Y
In Commercial Distribution

  • 00847627000194 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 7 Orange - 00847627000187

No Description
BIOCARE MEDICAL LLC
CFA7187A
In Commercial Distribution

  • 00847627000187 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 3 Aqua - 00847627000170

No Description
BIOCARE MEDICAL LLC
CFA7164Y
In Commercial Distribution

  • 00847627000170 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 3 Aqua - 00847627000163

No Description
BIOCARE MEDICAL LLC
CFA7164A
In Commercial Distribution

  • 00847627000163 ()


  • Nucleic acid hybridization detection IVD, probe

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
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