Catalog Number

-

Brand Name

Softdisc

Version/Model Number

Softdisc 5 count bag (English only)

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

377dd6ee-1249-4094-ba16-d3ffe1b2b98a

Public Version Date

August 03, 2022

Public Version Number

3

DI Record Publish Date

March 22, 2021

Package DI Number

10851906007474

Quantity per Package

18

Contains DI Package

00851906007477

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-