Catalog Number

-

Brand Name

FRED'S TAMPONS

Version/Model Number

FR21806UO/2

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

33a7b58d-fde0-4d04-b1db-2f98311d6685

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 13, 2016

Package DI Number

10084579122469

Quantity per Package

6

Contains DI Package

00084579122462

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE