Catalog Number

-

Brand Name

ROSE

Version/Model Number

Cardboard 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

8c7358ef-5100-4c1a-b227-f0d2a32ae6a3

Public Version Date

October 04, 2022

Public Version Number

1

DI Record Publish Date

September 26, 2022

Package DI Number

07290019338109

Quantity per Package

12

Contains DI Package

07290019338031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard