CARDINAL HEALTH - WHITE COMFORT BOUFFANT, 24 INCH - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: WHITE COMFORT BOUFFANT, 24 INCH

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More Product Details

Catalog Number

9303

Brand Name

CARDINAL HEALTH

Version/Model Number

9303

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

FYF

Product Code Name

CAP, SURGICAL

Device Record Status

Public Device Record Key

3aeced0c-9060-4f0f-ad21-ad85e14a38ef

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

June 26, 2019

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