Catalog Number

3338

Brand Name

Kerlix

Version/Model Number

3338

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 21, 2019

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KMF

Product Code Name

Bandage, liquid

Public Device Record Key

1b23e805-47aa-4f4e-99fc-3f1d445dc3c5

Public Version Date

October 12, 2020

Public Version Number

5

DI Record Publish Date

June 30, 2018

Package DI Number

30884521068319

Quantity per Package

192

Contains DI Package

10884521068315

Package Discontinue Date

August 21, 2019

Package Status

Not in Commercial Distribution

Package Type

CASE