Catalog Number

-

Brand Name

Cosmea

Version/Model Number

ultra super plus

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

HHD

Product Code Name

Pad, Menstrual, Unscented

Public Device Record Key

9483a22a-fba1-4e6d-a546-63e74f613b44

Public Version Date

September 22, 2020

Public Version Number

1

DI Record Publish Date

September 14, 2020

Package DI Number

04000576022068

Quantity per Package

12

Contains DI Package

04000576042066

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

sales Package