Duns Number:365732410
Device Description: Acellular fish skin for topical and surgical wounds.INTENDED USEKerecis® Burn is indicated Acellular fish skin for topical and surgical wounds.INTENDED USEKerecis® Burn is indicated for the management of wounds including:- Partial and full-thickness wounds,- Trauma wounds (abrasions, lacerations, second-degree burns, skintears).Pentagon MeshedDouble Pouchedhttps://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf
Catalog Number
50202M24D0D
Brand Name
Kerecis® Omega3 BURN
Version/Model Number
250cm2 Meshed Burn
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
bd81598b-4486-4e4c-97aa-d20351ecb4af
Public Version Date
February 23, 2021
Public Version Number
1
DI Record Publish Date
February 15, 2021
Package DI Number
05694310960687
Quantity per Package
10
Contains DI Package
05694310960670
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 |