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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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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
EdgeEndo Chlohexidine is a 2% Chlorhexidine Gluconate solution in water with surfactant to lower surface tension. The solution is a root canal cleanser for use in endotontic procedures.
EDGE ENDO LLC
EECHX
In Commercial Distribution

  • 00818365020041 ()

  • Total Volume: 480 Milliliter


  • Dental tooth-cleaning solution
SalivaMAX is a supersaturated calcium phosphate powder that when dissolved in water, creates a solution with a high concentration of electrolytes similar to that of natural saliva. SalivaMAX is an artificial saliva that is used to relieve acute and chronic symptoms of xerostomia and mucositis.
Forward Science Technologies LLC
SalivaMAX 300Ct
In Commercial Distribution

  • 00370275629306 ()


  • Artificial saliva
SalivaMAX is a supersaturated calcium phosphate powder that when dissolved in water, creates a solution with a high concentration of electrolytes similar to that of natural saliva. SalivaMAX is an artificial saliva that is used to relieve acute and chronic symptoms of xerostomia and mucositis.
Forward Science Technologies LLC
SalivaMAX 120Ct
In Commercial Distribution

  • 00370275629122 ()


  • Artificial saliva
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