CARDINAL HEALTH - DISPOSABLE SCRUB PANTS 2XL SMS BLUE ELASTIC LATEX - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: DISPOSABLE SCRUB PANTS 2XL SMS BLUE ELASTIC LATEX FREE NONSTERILE

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More Product Details

Catalog Number

23605PE

Brand Name

CARDINAL HEALTH

Version/Model Number

23605PE

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"

-

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

OEA

Product Code Name

Non-surgical isolation gown

Device Record Status

Public Device Record Key

745adfed-a23d-41a3-ad4a-ae456a88dd76

Public Version Date

October 29, 2018

Public Version Number

1

DI Record Publish Date

September 26, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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