DEVICE: Integra® Dermal Regeneration Template (10381780000617)
Device Identifier (DI) Information
Integra® Dermal Regeneration Template
38105
In Commercial Distribution
38105
Integra Lifesciences Corporation
38105
In Commercial Distribution
38105
Integra Lifesciences Corporation
INTEGRA Dermal Regeneration Template 8in. x 10in. (20cm x 25cm) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and a glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MGR | Dressing, Wound And Burn, Interactive |
MDD | Device, dermal replacement |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P900033 | 011 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store Flat |
Handling Environment Temperature: between 2 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 8 in x 10 in |
Device Record Status
63f03754-7ce6-4396-80f1-f88da76ade23
July 21, 2025
7
September 05, 2014
July 21, 2025
7
September 05, 2014
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
HIBCC | M269381051 |
Unit of Use DI
[?]
Unit of Use DI Number:
00381780000610
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)654-2873
custsvcnj@integralife.com
custsvcnj@integralife.com