Catalog Number

-

Brand Name

Family Wellness Tampons

Version/Model Number

100002843

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)

-

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

65176069-56aa-48ae-aaed-34a56948a230

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

June 22, 2018

Package DI Number

10032251432771

Quantity per Package

6

Contains DI Package

00032251432774

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE