Catalog Number

-

Brand Name

RAEL

Version/Model Number

Non-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

80f65d04-24fd-4549-9a33-c34659bf227e

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

February 02, 2018

Package DI Number

00859306006472

Quantity per Package

24

Contains DI Package

00859306006236

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-