Catalog Number

-

Brand Name

TOP The Organic Project

Version/Model Number

Organic Cotton Bio Based Applicator Tampon - Regular

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

34744e69-c46d-4969-b237-b019c5c5378e

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

October 31, 2019

Package DI Number

10855212008064

Quantity per Package

12

Contains DI Package

00855212008067

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-