Catalog Number

-

Brand Name

EMERITA

Version/Model Number

Applicator tampons multipack

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

28e8a5b6-fd87-42d3-af78-2aeeb363e382

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 28, 2017

Package DI Number

00356163738718

Quantity per Package

4

Contains DI Package

00356163890294

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bundle pack