Catalog Number

-

Brand Name

KeraStat Cream

Version/Model Number

00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

K192386,K192386

Product Code

KGN

Product Code Name

Dressing, Wound, Collagen

Public Device Record Key

8b38b4de-5d09-489f-8aca-e096ff734d8c

Public Version Date

April 28, 2021

Public Version Number

1

DI Record Publish Date

April 20, 2021

Package DI Number

B789P00211

Quantity per Package

24

Contains DI Package

B789P00210

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case