Catalog Number

MKN34733

Brand Name

Kendall

Version/Model Number

MKN34733

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

NAB

Product Code Name

Gauze / sponge,nonresorbable for external use

Public Device Record Key

8fe8bb13-8d8b-4780-978a-9f13dc8c9101

Public Version Date

August 24, 2021

Public Version Number

4

DI Record Publish Date

June 27, 2018

Package DI Number

00884521152154

Quantity per Package

25

Contains DI Package

00884521157081

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE