Duns Number:365732410
Device Description: Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Omega3 MariGen® Shield is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-omega3-marigen-shield/
Catalog Number
50215H51B0D
Brand Name
Kerecis® Omega3 MariGen® Shield
Version/Model Number
20 mm Circular
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
K213231,K213231
Product Code
KGN
Product Code Name
Dressing, Wound, Collagen
Public Device Record Key
9aa13ee8-a43b-4d6f-b5cb-0b2eff00189e
Public Version Date
August 30, 2022
Public Version Number
1
DI Record Publish Date
August 22, 2022
Package DI Number
05694310963763
Quantity per Package
10
Contains DI Package
05694310963756
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 |