Catalog Number

-

Brand Name

Kotex

Version/Model Number

Pad

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

HHD

Product Code Name

Pad, menstrual, unscented

Public Device Record Key

0bac66aa-211b-4a6b-b343-845444d08c05

Public Version Date

December 23, 2021

Public Version Number

1

DI Record Publish Date

December 15, 2021

Package DI Number

27441008171915

Quantity per Package

12

Contains DI Package

07441008171911

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case