Catalog Number

-

Brand Name

Flex Cup and Flex Disc

Version/Model Number

Flex Discovery Kit Full Fit

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

546c79bc-5626-4de1-ae4e-68e97ea5320b

Public Version Date

July 22, 2022

Public Version Number

4

DI Record Publish Date

March 14, 2019

Package DI Number

10851906007252

Quantity per Package

3

Contains DI Package

00851906007255

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack