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
50202P32D0D
Brand Name
Kerecis® Omega3 GraftGuide™
Version/Model Number
Micro 114 sq cm
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
K190528,K190528
Product Code
KGN
Product Code Name
Dressing, Wound, Collagen
Public Device Record Key
866a0be7-5581-4bdb-9a8f-60e76c5e7f99
Public Version Date
September 16, 2022
Public Version Number
1
DI Record Publish Date
September 08, 2022
Package DI Number
05694310963947
Quantity per Package
10
Contains DI Package
05694310963930
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 |