DEVICE: INTEGRA Wound Matrix (Thin) (10381780032403)
Device Identifier (DI) Information
INTEGRA Wound Matrix (Thin)
52021T
In Commercial Distribution
52021T
Integra Lifesciences Corporation
52021T
In Commercial Distribution
52021T
Integra Lifesciences Corporation
Integra Wound Matrix and Integra Wound Matrix (Thin) are collagen-glycosaminoglycan wound dressings that maintain and support a healing environment for wound management. Integra Wound Matrix (Thin) has 50% less collagen compared to each of the corresponding sq cm sizes of Integra Wound Matrix.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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 | Collagen wound matrix dressing |
A 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.
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FDA Product Code
[?]Product Code | Product Code Name |
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KGN | DRESSING, WOUND, COLLAGEN |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K113104 | 000 |
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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Width: 5 Centimeter |
Length: 2 Inch |
Length: 5 Centimeter |
Width: 2 Inch |
Device Record Status
bb235a22-d304-4d92-9a7c-7f542da96eb3
September 22, 2020
5
September 23, 2015
September 22, 2020
5
September 23, 2015
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 |
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HIBCC | M26952021T1 |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)654-2873
custsvcnj@integralife.com
custsvcnj@integralife.com