Catalog Number

50202S23D0D

Brand Name

Kerecis® Omega3 BURN

Version/Model Number

300cm2 Meshed Burn

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

-

Product Code

KGN

Product Code Name

Dressing, Wound, Collagen

Public Device Record Key

bed6b6a7-62bb-4161-a8cd-a52eede63bed

Public Version Date

January 13, 2021

Public Version Number

1

DI Record Publish Date

January 05, 2021

Package DI Number

05694310960571

Quantity per Package

10

Contains DI Package

05694310960564

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box