Catalog Number

CWL1158

Brand Name

KerraCel Ag

Version/Model Number

4 x 5in

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K162508,K162508,K162508

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

0bbc07dc-9ffb-4985-b2be-2310568306d3

Public Version Date

July 22, 2021

Public Version Number

4

DI Record Publish Date

October 01, 2019

Package DI Number

05060077233553

Quantity per Package

10

Contains DI Package

05060077233546

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper