Duns Number:365732410
Device Description: Fish skin for surgical use. INTENDED USE Kerecis® Omega3 SurgiBind™ is indicated for impla Fish skin for surgical use. INTENDED USE Kerecis® Omega3 SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. https://www.kerecis.com/wp-content/uploads/2021/10/KM-21-0117v2-IFU-Kerecis-SurgiBind.pdf
Catalog Number
50241S21D0D
Brand Name
Kerecis® Omega3 SurgiBind
Version/Model Number
7x20 cm
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K202430,K202430
Product Code
OXH
Product Code Name
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Public Device Record Key
549d1127-b920-4168-a5f1-4bb208e42f0c
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
October 11, 2021
Package DI Number
05694310961769
Quantity per Package
10
Contains DI Package
05694310961752
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 |