Catalog Number

-

Brand Name

McKesson

Version/Model Number

42-54

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

9e690197-51df-4d25-a33e-73a017d35472

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

June 05, 2020

Package DI Number

00815555023219

Quantity per Package

24

Contains DI Package

00815555023202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack