Duns Number:365732410
Device Description: Fish-Skin Graft for Surgical Use. Kerecis® Omega3 SurgiClose is indicated for the manageme Fish-Skin Graft for Surgical Use. Kerecis® Omega3 SurgiClose is indicated for the management of wounds including: Partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds.IFU: https://www.kerecis.com/ifus/ifu-kerecis-omega3-surgiclose/
Catalog Number
50205N18D0D
Brand Name
Kerecis® Omega3 SurgiClose
Version/Model Number
6x8 cm Meshed 2:1
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
K190528,K190528
Product Code
KGN
Product Code Name
Dressing, Wound, Collagen
Public Device Record Key
67840968-d3ff-43f3-b360-88db4de7513e
Public Version Date
September 16, 2022
Public Version Number
1
DI Record Publish Date
September 08, 2022
Package DI Number
05694310963848
Quantity per Package
10
Contains DI Package
05694310963831
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 |