Catalog Number

-

Brand Name

TopCare Tampons

Version/Model Number

BTCXC36

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

9832815e-95c5-40ce-99db-01fa6d72a9ac

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

January 03, 2018

Package DI Number

10036800441443

Quantity per Package

6

Contains DI Package

00036800441446

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE