Catalog Number

-

Brand Name

McKesson

Version/Model Number

61-59320

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EFQ

Product Code Name

Gauze/Sponge, Internal

Public Device Record Key

78da952c-98af-4eb0-a182-eb7c41ca25cc

Public Version Date

October 28, 2022

Public Version Number

3

DI Record Publish Date

June 10, 2020

Package DI Number

40612479136111

Quantity per Package

12

Contains DI Package

10612479136103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case