Duns Number:365732410
Device Description: Fish-Skin Graft for Burn Wound Management. Kerecis® Omega3 GraftGuide™ is indicated for th Fish-Skin Graft for Burn Wound Management. Kerecis® Omega3 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-omega3-graftguide/
Catalog Number
50202N24D0D
Brand Name
Kerecis® Omega3 GraftGuide™
Version/Model Number
250 sq cm Meshed
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGN
Product Code Name
Dressing, Wound, Collagen
Public Device Record Key
3985565d-8cf0-4026-a6a9-a46f9a68ad38
Public Version Date
January 27, 2022
Public Version Number
2
DI Record Publish Date
January 05, 2021
Package DI Number
05694310961004
Quantity per Package
10
Contains DI Package
05694310960991
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |
| U | Unclassified | 49 |