CARDINAL HEALTH - KIT,C SECTION PREP PK BETHESDA - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: KIT,C SECTION PREP PK BETHESDA

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More Product Details

Catalog Number

OR12242713

Brand Name

CARDINAL HEALTH

Version/Model Number

OR12242713

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

LRP

Product Code Name

TRAY, SURGICAL

Device Record Status

Public Device Record Key

b3376ec7-06a0-4a65-9c1f-eb62c58a3b3a

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

January 15, 2021

Additional Identifiers

Package DI Number

50888439992654

Quantity per Package

2

Contains DI Package

10888439992656

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