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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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EUSOL-C is a low salt, vitamin, amino acid, and glucose-enriched iso-osmolar corneal culture balanced medium with sodium piruvate as an ATP precursor and dextran as a deturgescent agent. It is supplemented with 143 ug/ml gentamicin sulfate. It has sodium bicarbonate and Hepes buffers to maintain pH in the range of 7.2 – 7.6 and Phenol red as a pH indicator. EUSOL-C is for storage of donor corneas at 2°C – 8°C for up to 14 days. It provides basic nutrients for cell maintenance and prevents tissue swelling preserving corneal thickness.
AL.CHI.MI.A. SRL
CSM 001-00
In Commercial Distribution

  • 18021118000590 ()
  • 08021118000593 ()

  • Total Volume: 20 Milliliter


  • Corneal storage medium
TheraGenesis Non-Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine collagen sponge layer and a silicone film layer. The collagen sponge layer should be applied to the wound surface. The device also contain a synthetic gauze material to add strength to the silicone film layer. When applied to full-thickness skin defects, TheraGenesis Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. TheraGenesis Non-Meshed Bilayer Wound Matrix is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.
GUNZE LIMITED
TG-B8290
In Commercial Distribution

  • 04967162947153 ()

  • Width: 82 Millimeter
  • Length: 90 Millimeter
TG-B8290

  • Animal-derived wound matrix dressing
TheraGenesis Non-Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine collagen sponge layer and a silicone film layer. The collagen sponge layer should be applied to the wound surface. The device also contain a synthetic gauze material to add strength to the silicone film layer. When applied to full-thickness skin defects, TheraGenesis Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. TheraGenesis Non-Meshed Bilayer Wound Matrix is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.
GUNZE LIMITED
TG-B8260
In Commercial Distribution

  • 04967162947146 ()

  • Width: 82 Millimeter
  • Length: 60 Millimeter
TG-B8260

  • Animal-derived wound matrix dressing
TheraGenesis Non-Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine collagen sponge layer and a silicone film layer. The collagen sponge layer should be applied to the wound surface. The device also contain a synthetic gauze material to add strength to the silicone film layer. When applied to full-thickness skin defects, TheraGenesis Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. TheraGenesis Non-Meshed Bilayer Wound Matrix is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.
GUNZE LIMITED
TG-B82120
In Commercial Distribution

  • 04967162947139 ()

  • Width: 82 Millimeter
  • Length: 120 Millimeter
TG-B82120

  • Animal-derived wound matrix dressing
TheraGenesis Non-Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine collagen sponge layer and a silicone film layer. The collagen sponge layer should be applied to the wound surface. The device also contain a synthetic gauze material to add strength to the silicone film layer. When applied to full-thickness skin defects, TheraGenesis Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. TheraGenesis Non-Meshed Bilayer Wound Matrix is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.
GUNZE LIMITED
TG-B4060
In Commercial Distribution

  • 04967162947122 ()

  • Width: 40 Millimeter
  • Length: 60 Millimeter
TG-B4060

  • Animal-derived wound matrix dressing
TheraGenesis Non-Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine collagen sponge layer and a silicone film layer. The collagen sponge layer should be applied to the wound surface. The device also contain a synthetic gauze material to add strength to the silicone film layer. When applied to full-thickness skin defects, TheraGenesis Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. TheraGenesis Non-Meshed Bilayer Wound Matrix is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.
GUNZE LIMITED
TG-B4030
In Commercial Distribution

  • 04967162947115 ()

  • Width: 40 Millimeter
  • Length: 30 Millimeter
TG-B4030

  • Animal-derived wound matrix dressing
TheraGenesis Non-Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine collagen sponge layer and a silicone film layer. The collagen sponge layer should be applied to the wound surface. The device also contain a synthetic gauze material to add strength to the silicone film layer. When applied to full-thickness skin defects, TheraGenesis Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. TheraGenesis Non-Meshed Bilayer Wound Matrix is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.
GUNZE LIMITED
TG-B200240
In Commercial Distribution

  • 04967162947108 ()

  • Width: 200 Millimeter
  • Length: 240 Millimeter
TG-B200240

  • Animal-derived wound matrix dressing
TheraGenesis Non-Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine collagen sponge layer and a silicone film layer. The collagen sponge layer should be applied to the wound surface. The device also contain a synthetic gauze material to add strength to the silicone film layer. When applied to full-thickness skin defects, TheraGenesis Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. TheraGenesis Non-Meshed Bilayer Wound Matrix is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.
GUNZE LIMITED
TG-B120240
In Commercial Distribution

  • 04967162947092 ()

  • Width: 120 Millimeter
  • Length: 240 Millimeter
TG-B120240

  • Animal-derived wound matrix dressing
The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053001118 ()
  • 00870053001114 ()
  • 50870053001119 ()
1052

  • General oral wound dressing, animal-derived
The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053001033 ()
  • 00870053001039 ()
  • 50870053001034 ()
1050

  • General oral wound dressing, animal-derived
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