Duns Number:365732410
Device Description: "Acellular fish skin for topical and surgical wounds.INTENDED USE Kerecis® Omega 3 Wound i
Catalog Number
50200P04D0D
Brand Name
Kerecis® Omega3 Wound
Version/Model Number
7x7 Particularized Wound
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 24, 2022
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
e6d3690f-9f22-4429-ac24-d0f638ac0337
Public Version Date
March 02, 2022
Public Version Number
2
DI Record Publish Date
May 01, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |