Duns Number:365732410
Device Description: "Acellular fish skin for topical and surgical wounds.INTENDED USE Kerecis® Omega 3 Wound i "Acellular fish skin for topical and surgical wounds.INTENDED USE Kerecis® Omega 3 Wound 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, second-degree burns, skin tears) •Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) •Draining WoundsParticularized, double pouchhttps://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf"
Catalog Number
50200P02D0D
Brand Name
Kerecis® Omega3 Wound
Version/Model Number
3x7 Fragmented Wound
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 27, 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
30f79a77-8108-46f6-b756-94fee2384cb6
Public Version Date
March 02, 2022
Public Version Number
3
DI Record Publish Date
May 01, 2021
Package DI Number
05694310960960
Quantity per Package
10
Contains DI Package
05694310960953
Package Discontinue Date
January 27, 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 |