Catalog Number

-

Brand Name

FRED'S TAMPONS

Version/Model Number

FR11806SO

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

K050067,K050067,K050067

Product Code

HIL

Product Code Name

Tampon, Menstrual, Scented, Deodorized

Public Device Record Key

670b0c3d-5ff7-4fed-abf8-345a3a6f550c

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 13, 2016

Package DI Number

10084579122476

Quantity per Package

6

Contains DI Package

00084579122479

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE