Catalog Number

MKN42965

Brand Name

Kendall

Version/Model Number

MKN42965

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

K011941,K011941,K011941

Product Code

EFQ

Product Code Name

GAUZE/SPONGE, INTERNAL

Public Device Record Key

9011555c-f4d2-4f93-bb05-7e4c9226c3d1

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

June 29, 2018

Package DI Number

00884521152741

Quantity per Package

50

Contains DI Package

00884521152758

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE