CONVERTORS - Large Sheet - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: Large Sheet

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More Product Details

Catalog Number

9446

Brand Name

CONVERTORS

Version/Model Number

9446

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

PUI

Product Code Name

Drape, surgical, exempt

Device Record Status

Public Device Record Key

411fb749-4d91-4433-ae55-ec86b137e3b8

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

August 23, 2018

Additional Identifiers

Package DI Number

50885380155329

Quantity per Package

30

Contains DI Package

10885380155321

Package Discontinue Date

-

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