Duns Number:365732410
Device Description: Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the manageme
Catalog Number
50200S21B0D
Brand Name
Kerecis® Omega3 MariGen
Version/Model Number
7x20 cm
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 17, 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
K132343,K132343
Product Code
KGN
Product Code Name
Dressing, Wound, Collagen
Public Device Record Key
21952408-625c-4879-bcee-dbae77a39580
Public Version Date
February 18, 2022
Public Version Number
3
DI Record Publish Date
February 15, 2021
Package DI Number
05694310960588
Quantity per Package
10
Contains DI Package
05694310960311
Package Discontinue Date
February 17, 2022
Package Status
Not 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 |