CARDINAL HEALTH - PEDS UROLOGY PACK - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: PEDS UROLOGY PACK

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More Product Details

Catalog Number

SBA12PUHM4

Brand Name

CARDINAL HEALTH

Version/Model Number

SBA12PUHM4

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NWU

Product Code Name

Endoscope introducer kit

Device Record Status

Public Device Record Key

81408caa-e7b3-49ae-b6ee-157d2d9852b1

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

December 28, 2021

Additional Identifiers

Package DI Number

50195594486264

Quantity per Package

2

Contains DI Package

10195594486266

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