Catalog Number

-

Brand Name

FIORE

Version/Model Number

44R1008

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

213bae54-560e-40b5-8f87-07b52791231c

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

May 19, 2022

Package DI Number

10876254003626

Quantity per Package

12

Contains DI Package

00876254003629

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE