Catalog Number

6641

Brand Name

Kendall

Version/Model Number

6641

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)

Yes

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

5590e3d5-4f87-4801-b92b-5bbbbc2809a2

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

June 27, 2018

Package DI Number

30884521007035

Quantity per Package

200

Contains DI Package

10884521007031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE