Catalog Number

MKN43097

Brand Name

Kendall

Version/Model Number

MKN43097

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

74d80a22-b394-470c-b1e3-3d4783f51bf4

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

June 29, 2018

Package DI Number

00884521152765

Quantity per Package

24

Contains DI Package

00884521170745

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE