Catalog Number

-

Brand Name

Smart Sense Tampons

Version/Model Number

BKMGR18

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

9a2c91df-011c-4b69-a6f5-72fe8ff03319

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 20, 2016

Package DI Number

10883967382238

Quantity per Package

12

Contains DI Package

00883967382231

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE