Catalog Number

-

Brand Name

KeraStat Gel

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

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

K162759,K162759

Product Code

KGN

Product Code Name

Dressing, Wound, Collagen

Public Device Record Key

ad5386d3-c6b5-4892-8279-27e40c7fad8f

Public Version Date

April 28, 2021

Public Version Number

1

DI Record Publish Date

April 20, 2021

Package DI Number

B789P00101

Quantity per Package

24

Contains DI Package

B789P00100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case