Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-89144

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"

Yes

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

432384be-f586-419b-b3a0-9e508925e509

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

July 15, 2020

Package DI Number

20612479185023

Quantity per Package

25

Contains DI Package

10612479185019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case