TheraGenesis Bilayer Wound Matrix TG-B120240

GUDID 04967162947092

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

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Primary Device ID04967162947092
NIH Device Record Keyac12ba9e-62b9-42f1-805c-3057f57e1d53
Commercial Distribution StatusIn Commercial Distribution
Brand NameTheraGenesis Bilayer Wound Matrix
Version Model NumberTG-B120240
Catalog NumberTG-B120240
Company DUNS694678546
Company NameGUNZE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Width120 Millimeter
Length240 Millimeter
Width120 Millimeter
Length240 Millimeter
Width120 Millimeter
Length240 Millimeter
Width120 Millimeter
Length240 Millimeter
Width120 Millimeter
Length240 Millimeter
Width120 Millimeter
Length240 Millimeter
Width120 Millimeter
Length240 Millimeter
Width120 Millimeter
Length240 Millimeter
Width120 Millimeter
Length240 Millimeter
Width120 Millimeter
Length240 Millimeter
Width120 Millimeter
Length240 Millimeter
Width120 Millimeter
Length240 Millimeter
Width120 Millimeter
Length240 Millimeter
Width120 Millimeter
Length240 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104967162947092 [Primary]

FDA Product Code

KGNDressing, Wound, Collagen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-22
Device Publish Date2020-09-14

On-Brand Devices [TheraGenesis Bilayer Wound Matrix]

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

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