CARDINAL HEALTH - BANDAGE COMPRESSION 3IN X 5YD SELF ADHERENT CASE - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: BANDAGE COMPRESSION 3IN X 5YD SELF ADHERENT CASE PACK NONSTERILE GREEN

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More Product Details

Catalog Number

CAH35LFGR

Brand Name

CARDINAL HEALTH

Version/Model Number

CAH35LFGR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 18, 2021

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

KGX

Product Code Name

Tape and bandage, adhesive

Device Record Status

Public Device Record Key

1d332543-dd64-4c3f-94d7-88aaa3a8e86f

Public Version Date

December 08, 2021

Public Version Number

5

DI Record Publish Date

June 30, 2019

Additional Identifiers

Package DI Number

00888499007188

Quantity per Package

24

Contains DI Package

10885380102349

Package Discontinue Date

November 18, 2021

Package Status

Not in Commercial Distribution

Package Type

BOX

"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