CONVERTORS - Universal Split Pack II - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: Universal Split Pack II

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More Product Details

Catalog Number

29133

Brand Name

CONVERTORS

Version/Model Number

29133

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

LRO

Product Code Name

General surgery tray (kit)

Device Record Status

Public Device Record Key

3d4db37a-f27f-48bb-880c-b52d7783ef90

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

June 28, 2016

Additional Identifiers

Package DI Number

50885380037946

Quantity per Package

10

Contains DI Package

10885380037948

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