Catalog Number

-

Brand Name

Flex Cup

Version/Model Number

Single Flex Cup Full Fit (Size 2) box

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

8fdc0717-9001-44f7-9b43-2f640d8a252f

Public Version Date

January 26, 2022

Public Version Number

3

DI Record Publish Date

April 15, 2019

Package DI Number

20851906007198

Quantity per Package

6

Contains DI Package

10851906007191

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case