Catalog Number

6647

Brand Name

Kendall

Version/Model Number

6647

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

598dc85c-4ede-4673-bb1f-2b1a0185499e

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

June 29, 2018

Package DI Number

30884521007172

Quantity per Package

120

Contains DI Package

10884521007178

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE