Catalog Number

-

Brand Name

Softcup

Version/Model Number

Box of Softcup 14 count (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

4b6dcc3e-89fe-46c7-8019-802603dbaa0d

Public Version Date

January 26, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

10851906007030

Quantity per Package

18

Contains DI Package

00851906007033

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case