DEVICE: Kerecis® GraftGuide® (05694310961011)
Device Identifier (DI) Information
Kerecis® GraftGuide®
300 sq cm Meshed
In Commercial Distribution
50202N23D0D
KERECIS hf.
300 sq cm Meshed
In Commercial Distribution
50202N23D0D
KERECIS hf.
Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide® is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts.
IFU: https://www.kerecis.com/ifus/ifu-kerecis-graftguide/
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
Yes | |
Yes | |
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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 |
---|---|
KGN | Dressing, Wound, Collagen |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: less than 25 Degrees Celsius |
Storage Environment Temperature: less than 77 Degrees Fahrenheit |
Special Storage Condition, Specify: Keep away from sunlight |
Special Storage Condition, Specify: Keep dry |
Clinically Relevant Size
[?]Size Type Text |
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Area/Surface Area: 300 Square centimeter |
Device Record Status
2604cce7-d1d0-4119-aefd-a6dd725dc472
July 21, 2025
4
January 05, 2021
July 21, 2025
4
January 05, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05694310961028 | 10 | 05694310961011 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
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
[?]
7032878752
info@kerecis.com
info@kerecis.com