TheraGenesis Bilayer Wound Matrix TG-B82120

GUDID 04967162947139

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	04967162947139
NIH Device Record Key	5a52ef42-b7c7-4833-afb1-f698c5583db6
Commercial Distribution Status	In Commercial Distribution
Brand Name	TheraGenesis Bilayer Wound Matrix
Version Model Number	TG-B82120
Catalog Number	TG-B82120
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	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 Millimeter
Width	82 Millimeter
Length	120 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	04967162947139 [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: