Catalog Number

-

Brand Name

ORGANYC

Version/Model Number

Applicator Super

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

56bdaa8a-0d25-4717-be43-519c5d044151

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

38016867008960

Quantity per Package

6

Contains DI Package

08016867008969

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-