CARDINAL HEALTH - LAB JACKET CARDINAL HEALTH THREE-LAYER SMS SMALL - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: LAB JACKET CARDINAL HEALTH THREE-LAYER SMS SMALL HIP LENGTH SNAP CLOSURE KNIT COLLAR POCKE LAB JACKET CARDINAL HEALTH THREE-LAYER SMS SMALL HIP LENGTH SNAP CLOSURE KNIT COLLAR POCKET

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More Product Details

Catalog Number

C3630RBS

Brand Name

CARDINAL HEALTH

Version/Model Number

C3630RBS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

June 26, 2023

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

LYU

Product Code Name

ACCESSORY, SURGICAL APPAREL

Device Record Status

Public Device Record Key

f3d5a48b-7126-4cf1-8551-b3a9b79609fc

Public Version Date

June 28, 2021

Public Version Number

2

DI Record Publish Date

April 30, 2019

Additional Identifiers

Package DI Number

50885380167841

Quantity per Package

10

Contains DI Package

20885380167840

Package Discontinue Date

June 26, 2023

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