Catalog Number

50205N23D0D

Brand Name

Kerecis® Omega3 SurgiClose

Version/Model Number

300 sq 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

a8c36367-24a3-4c22-a903-e3e748fd7761

Public Version Date

February 17, 2022

Public Version Number

4

DI Record Publish Date

January 05, 2021

Package DI Number

05694310961066

Quantity per Package

10

Contains DI Package

05694310961059

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box