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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-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
TendoNova Disposable Unit 60mm Kit-Single
Tendonova Corporation
DU1F60L-K
In Commercial Distribution

  • 00860009899865 ()

  • Length: 60 Millimeter


  • Skin topical coupling gel
  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
  • Skin-cover adhesive strip, non-antimicrobial
  • Patient surgical drape, single-use
  • Orthopaedic implant aiming arm
The Brux-TMD Quicksplint is a patented anterior bite plate that covers the upper or lower front teeth from bicuspid through bicuspid. It is a two component device with a hard plastic shell and a softer compliant lining that conforms to the supporting teeth. The operator may optionally place it on the anterior maxillary or mandibular arch. While it is worn, the Brux-TMD Quicksplint temporarily inhibits the full force of parafunctional teeth clenching, and gives the pericranial musculature and opportunity to relax. This reduces the muscular tension that underlies the pain associated with many bruxism headaches and the pain associated with TMD dysfunction. It reduces the muscle tension in trigeminal innervated cranial-facial muscles, thereby reducing the pain occurrence. In addition, it physically protects the teeth from nighttime bruxing activities by covering the dental occlusal surfaces with a durable plastic covering.
TRUER MEDICAL, INC.
90509
In Commercial Distribution

  • 00859290006151 ()
  • 10859290006158 ()
  • 20859290006155 ()
  • 30859290006152 ()
90000FG

  • Mouthguard, reusable
TheraGenesis 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, and has slits to aid in the drainage of exudate. 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 Meshed Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. TheraGenesis 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-M8290
In Commercial Distribution

  • 04967162947221 ()

  • Width: 82 Millimeter
  • Length: 90 Millimeter
TG-M8290

  • Animal-derived wound matrix dressing
TheraGenesis 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, and has slits to aid in the drainage of exudate. 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 Meshed Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. TheraGenesis 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-M8260
In Commercial Distribution

  • 04967162947214 ()

  • Width: 82 Millimeter
  • Length: 60 Millimeter
TG-M8260

  • Animal-derived wound matrix dressing
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