Catalog Number

-

Brand Name

SMART SENSE Tampons

Version/Model Number

BKMXC36

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

HEB

Product Code Name

Tampon, Menstrual, Unscented

Public Device Record Key

5e0c83bb-0a88-4381-899b-1c84b4afe556

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

May 02, 2017

Package DI Number

10883967418388

Quantity per Package

12

Contains DI Package

00883967418381

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE