Catalog Number

50241G21D0D

Brand Name

Kerecis® Omega3 SurgiBind

Version/Model Number

7x20 cm Fenestrated

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

01bb0ce7-6977-4379-bd0b-af508a5cea5c

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

October 11, 2021

Package DI Number

05694310961820

Quantity per Package

10

Contains DI Package

05694310961813

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box