DEVICE: Integra® (10381780032397)

Device Identifier (DI) Information

Integra®
MWM8101
In Commercial Distribution
MWM8101
Integra Lifesciences Corporation
10381780032397
GS1

1
083171244 *Terms of Use
Integra® MESHED BILAYER WOUND MATRIX 8 in*10 in (20 cm*25 cm)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45023 Animal-derived wound matrix dressing
A bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FRO Dressing, wound, drug
KGN Dressing, wound, collagen
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K081635 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store Flat
Handling Environment Temperature: between 10 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Length: 25 Centimeter
Length: 10 Inch
Width: 8 Inch
Width: 20 Centimeter
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Device Record Status

15850de3-4e62-44a8-8278-0cb67bea5763
July 21, 2025
10
September 23, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
HIBCC M269MWM81011
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)654-2873
custsvcnj@integralife.com
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