CONVERTORS - LAVH/Laparoscopy Drape - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: LAVH/Laparoscopy Drape

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More Product Details

Catalog Number

29474

Brand Name

CONVERTORS

Version/Model Number

29474

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

4a68c102-6d5a-4f55-b2eb-57be8791689c

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

September 28, 2017

Additional Identifiers

Package DI Number

50885380141650

Quantity per Package

8

Contains DI Package

10885380141652

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