Catalog Number

-

Brand Name

Kotex

Version/Model Number

Liner

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"

-

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

NRC

Product Code Name

Pads, menstrual, scented-deodorized

Public Device Record Key

147cf435-37d0-4e65-8d42-ffeaffc048ea

Public Version Date

December 23, 2021

Public Version Number

1

DI Record Publish Date

December 15, 2021

Package DI Number

17702425810867

Quantity per Package

12

Contains DI Package

07702425810860

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case