Catalog Number

8451

Brand Name

CARDINAL HEALTH

Version/Model Number

8451

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

November 04, 2024

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

FXP

Product Code Name

COVER, SHOE, OPERATING-ROOM

Public Device Record Key

ea0fe90b-6645-44c2-ae56-e68e09946935

Public Version Date

December 03, 2021

Public Version Number

3

DI Record Publish Date

November 14, 2018

Package DI Number

50885380068070

Quantity per Package

4

Contains DI Package

20885380068079

Package Discontinue Date

November 04, 2024

Package Status

In Commercial Distribution

Package Type

CASE