TheraGenesis Bilayer Wound Matrix TG-B200240

GUDID 04967162947108

TheraGenesis 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 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

Collagen wound matrix dressing

• Primary Device ID: 04967162947108
• NIH Device Record Key: 6818cdf0-1449-4f72-920c-8aec4abc1e12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraGenesis Bilayer Wound Matrix
• Version Model Number: TG-B200240
• Catalog Number: TG-B200240
• Company DUNS: 694678546
• Company Name: GUNZE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter
• Width: 200 Millimeter
• Length: 240 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04967162947108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191992

FDA Product Code

• KGN: Dressing, Wound, Collagen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-22
• Device Publish Date: 2020-09-14

On-Brand Devices [TheraGenesis Bilayer Wound Matrix]

• 04967162947153: TheraGenesis Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers:
• 04967162947146: TheraGenesis Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers:
• 04967162947139: TheraGenesis Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers:
• 04967162947122: TheraGenesis Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers:
• 04967162947115: TheraGenesis Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers:
• 04967162947108: TheraGenesis Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers:
• 04967162947092: TheraGenesis Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: