FRED'S TAMPONS - REGULAR UNSCENTED PLASTIC APPLICATOR TAMPONS - FRED'S, INC.

Duns Number:005866116

Device Description: REGULAR UNSCENTED PLASTIC APPLICATOR TAMPONS

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More Product Details

Catalog Number

-

Brand Name

FRED'S TAMPONS

Version/Model Number

FR11806UO

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

HEB

Product Code Name

Tampon, Menstrual, Unscented

Device Record Status

Public Device Record Key

2cf29635-24f6-4840-bab6-0befb1cbe407

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 13, 2016

Additional Identifiers

Package DI Number

10084579122452

Quantity per Package

6

Contains DI Package

00084579122455

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"FRED'S, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4