FDA.reportPublic FDA data

INTEGRA Meshed Bilayer Wound Matrix

Primary DI
M269MWM20211
Brand
INTEGRA Meshed Bilayer Wound Matrix
Company
Integra Lifesciences Corporation
Model
MWM2021
Catalog number
MWM2021
Device description
INTEGRA Meshed Bilayer Wound Matrix is an advanced woundcare device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan and a semi-permeable polysiloxane (silicone) layer. The meshed bylayer matrix allows drainage of wound exudate and provides a flexible adherent covering for the wound surface. The collagen-glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.
Published
2015-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, wound, drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081635000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081635000INTEGRA MESHED BILAYER WOUND MATRIXIntegra Lifesciences Corp.2008-12-04KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780032366PrimaryGS10
M269MWM20211SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178003236610381780032366

GMDN Terms#

Term, Definition table
TermDefinition
Skin regeneration template, human-/animal-derivedA sterile covering used as a temporary skin substitute on wounds (e.g., diabetic or venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix, typically 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 contains human- and animal-derived products (e.g., bovine, porcine), or only animal-derived products. It may be mono- or bi-layered, and may contain natural and synthetic materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2Inch
Length5Centimeter
Width2Inch
Width5Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Store Flat

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
083171244
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780112075Integra OS™IOS10125IOS101252015-09-23
10381780112082Integra OS™IOS10155IOS101552015-09-23
10381780112426Trel-XC PasteTXCPA01TXCPA012015-09-22
10381780112433Trel-XC PasteTXCPA03TXCPA032015-09-22
10381780112440Trel-XC PasteTXCPA08TXCPA082015-09-22
10381780112457Trel-XC PuttyTXCPY05TXCPY052015-09-22
10381780112464Trel-XC PuttyTXCPY10TXCPY102015-09-22
10381780112471Trel-X PuttyTXP05TXP052015-09-22
10381780112488Trel-X PuttyTXP10TXP102015-09-22
10381780112495Trel-X GelTXG01TXG012015-09-22
10381780112501Trel-X GelTXG05TXG052015-09-22
10381780112518Trel X-Press 100XPRES110XPRES1102015-09-22
10381780112525Trel X-Press 100XPRES105XPRES1052015-09-22
10381780112532Trel X-Press 100XPRES125XPRES1252015-09-22
10381780112556Trel X-Press 300XPRES305XPRES3052015-09-25
10381780112563Trel X-Press 300XPRES325XPRES3252015-09-25
10381780112570Trel XPress 300CXPres3c10XPres3c102015-09-25
10381780114338Collage Osteoconductive Scaffold - Putty7100057100052015-09-22
10381780114345Collage Osteoconductive Scaffold - Putty7100107100102015-09-22
10381780114352Collage Osteoconductive Scaffold - Putty7100157100152015-09-22

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10841277111382Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111405Novera SeamHarps USA, Inc.FRO2026-10-14
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10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
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10885380214844DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214851DermaceaCardinal Health 200, LLCFRO2026-10-09
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