Catalog Number

-

Brand Name

Softcup

Version/Model Number

10089

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"

Yes

For Single-Use

-

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

HHE

Product Code Name

Cup, Menstrual

Public Device Record Key

f7bfd2c1-174c-4db3-a465-3342c586464d

Public Version Date

January 26, 2022

Public Version Number

2

DI Record Publish Date

October 27, 2021

Package DI Number

10851906007399

Quantity per Package

3

Contains DI Package

00851906007439

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack