FDA.reportPublic FDA data

TheraGenesis Non-Meshed Bilayer Wound Matrix

Primary DI
04967162947108
Brand
TheraGenesis Non-Meshed Bilayer Wound Matrix
Company
GUNZE LIMITED
Model
TG-B200240
Catalog number
TG-B200240
Device description
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.
Published
2020-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGNDressing, Wound, Collagen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191992000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191992000PELNAC Bilayer Wound MatrixGunze Limited2020-04-29KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04967162947108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04967162947108049671629471084967162947108

GMDN Terms#

Term, Definition table
TermDefinition
Collagen wound matrix dressingA sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length240Millimeter
Width200Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694678546
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04548366322450NEOVEILNV-L-05GNV-L-05G2025-04-21
04548366322467NEOVEILNV-L-04GNV-L-04G2025-04-21
04548366322474NEOVEILNV-L-03GNV-L-03G2025-04-21
04548366322498NEOVEILNV-M-05GNV-M-05G2025-04-21
04548366322504NEOVEILNV-M-04GNV-M-04G2025-04-21
04548366322511NEOVEILNV-M-03GNV-M-03G2025-04-21
04548366322528NEOVEILNV-M-015GNV-M-015G2025-04-21
04548366322535NEOVEILNV-S-04GNV-S-04G2025-04-21
04548366322542NEOVEILNV-S-03GNV-S-03G2025-04-21
04548366322559NEOVEILNV-S-015GNV-S-015G2025-04-21
04548366830313NEOVEILNV-S-05GNV-S-05G2025-04-21
04548366830337NEOVEILNV-LL-015GNV-LL-015G2025-04-21
04973077713776NEOVEILNV-ET-M60E-3NV-ET-M60E-32023-03-27
04973077713783NEOVEILNV-ET-M60L-3NV-ET-M60L-32023-03-27
04547301462534NEOVEILNV-ET-M60A-2NV-ET-M60A-22021-01-06
04547301462558NEOVEILNV-ET-M60E-2NV-ET-M60E-22021-01-06
04548366322481NEOVEILNV-L-015GNV-L-015G2019-11-04
04967162947092TheraGenesis Non-Meshed Bilayer Wound MatrixTG-B120240TG-B1202402020-09-14
04967162947115TheraGenesis Non-Meshed Bilayer Wound MatrixTG-B4030TG-B40302020-09-14
04967162947122TheraGenesis Non-Meshed Bilayer Wound MatrixTG-B4060TG-B40602020-09-14

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