Catalog Number

8453

Brand Name

CARDINAL HEALTH

Version/Model Number

8453

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

FXP

Product Code Name

COVER, SHOE, OPERATING-ROOM

Public Device Record Key

b46806a8-2ef7-43a9-96f6-353cd9d2120e

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

November 14, 2018

Package DI Number

50885380132580

Quantity per Package

4

Contains DI Package

20885380132589

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE