TheraGenesis Meshed Bilayer Wound Matrix TG-M82120

GUDID 04967162947207

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

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Primary Device ID04967162947207
NIH Device Record Keyabe0a62c-4c9c-4a88-b199-be544aa1c2e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameTheraGenesis Meshed Bilayer Wound Matrix
Version Model NumberTG-M82120
Catalog NumberTG-M82120
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

Width82 Millimeter
Length120 Millimeter
Width82 Millimeter
Length120 Millimeter
Width82 Millimeter
Length120 Millimeter
Width82 Millimeter
Length120 Millimeter
Width82 Millimeter
Length120 Millimeter
Width82 Millimeter
Length120 Millimeter
Width82 Millimeter
Length120 Millimeter
Width82 Millimeter
Length120 Millimeter
Width82 Millimeter
Length120 Millimeter
Width82 Millimeter
Length120 Millimeter
Width82 Millimeter
Length120 Millimeter
Width82 Millimeter
Length120 Millimeter
Width82 Millimeter
Length120 Millimeter
Width82 Millimeter
Length120 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
GS104967162947207 [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 Meshed Bilayer Wound Matrix]

04967162947221TheraGenesis Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two l
04967162947214TheraGenesis Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two l
04967162947207TheraGenesis Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two l
04967162947191TheraGenesis Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two l
04967162947184TheraGenesis Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two l
04967162947177TheraGenesis Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two l
04967162947160TheraGenesis Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two l

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