Catalog Number

50205S18D0D

Brand Name

Kerecis® Omega3 SurgiClose

Version/Model Number

6x8 cm

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

0049b7b6-3dbb-4819-80a5-fff063e3c9ed

Public Version Date

September 16, 2022

Public Version Number

1

DI Record Publish Date

September 08, 2022

Package DI Number

05694310963909

Quantity per Package

10

Contains DI Package

05694310963893

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box