CARDINAL HEALTH - SHOECOVER, CRITICAL ZONE, X-LG - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: SHOECOVER, CRITICAL ZONE, X-LG

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

8454

Brand Name

CARDINAL HEALTH

Version/Model Number

8454

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

November 04, 2024

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FXP

Product Code Name

COVER, SHOE, OPERATING-ROOM

Device Record Status

Public Device Record Key

877f720f-21ed-4452-a4b0-ce75d38947d8

Public Version Date

December 03, 2021

Public Version Number

3

DI Record Publish Date

July 01, 2019

Additional Identifiers

Package DI Number

50885380019133

Quantity per Package

4

Contains DI Package

20885380019132

Package Discontinue Date

November 04, 2024

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH 200, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 101686
2 A medical device with a moderate to high risk that requires special controls. 139430
3 A medical device with high risk that requires premarket approval 8
U Unclassified 40