Catalog Number

6662

Brand Name

Kerlix

Version/Model Number

6662

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)

Yes

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

8ef902be-d7d0-46c3-8735-8e267d32190f

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

June 30, 2018

Package DI Number

20884521020044

Quantity per Package

40

Contains DI Package

10884521020047

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK