Catalog Number

-

Brand Name

Softdisc

Version/Model Number

Box of Softdisc 14 count (English/French for Canada)

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

HHE

Product Code Name

Cup, Menstrual

Public Device Record Key

40db4c42-1568-4c8e-9b47-c733afb9f08b

Public Version Date

July 29, 2022

Public Version Number

1

DI Record Publish Date

July 21, 2022

Package DI Number

10851906007023

Quantity per Package

18

Contains DI Package

00851906007026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case