Catalog Number

C15055-006

Brand Name

CARDINAL HEALTH

Version/Model Number

C15055-006

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

KXF

Product Code Name

APPLICATOR, ABSORBENT TIPPED, NON-STERILE

Public Device Record Key

24412f3e-1fd3-427a-b814-8808d2b05077

Public Version Date

September 07, 2021

Public Version Number

1

DI Record Publish Date

August 30, 2021

Package DI Number

50885380179899

Quantity per Package

10

Contains DI Package

20885380179898

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE