Catalog Number

CWL1006

Brand Name

KerraLite Cool

Version/Model Number

7 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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NAE

Product Code Name

Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Public Device Record Key

68f5981f-7f3d-45f1-9c85-a53a7145fc9c

Public Version Date

September 09, 2020

Public Version Number

3

DI Record Publish Date

October 01, 2019

Package DI Number

05060077230613

Quantity per Package

5

Contains DI Package

05060077231252

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton