Catalog Number

CWL1134

Brand Name

KerraFoam Gentle Border

Version/Model Number

4 x 12in

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NAD

Product Code Name

Dressing, Wound, Occlusive

Public Device Record Key

a8ebd09c-5309-4dc2-a503-a7e2d1492781

Public Version Date

June 22, 2021

Public Version Number

4

DI Record Publish Date

October 01, 2019

Package DI Number

05060077232549

Quantity per Package

9

Contains DI Package

05060077232532

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper