Catalog Number

MKN45823

Brand Name

Kendall

Version/Model Number

MKN45823

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2021

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

FRO

Product Code Name

Dressing, wound, drug

Public Device Record Key

7ee1c6c4-fee4-4621-beef-51317e4b8897

Public Version Date

June 30, 2021

Public Version Number

7

DI Record Publish Date

June 30, 2018

Package DI Number

00884521152833

Quantity per Package

10

Contains DI Package

00884521152840

Package Discontinue Date

April 27, 2020

Package Status

Not in Commercial Distribution

Package Type

PACK_OR_INNER_PACK