Catalog Number

-

Brand Name

Flex

Version/Model Number

Flex 8 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

8336b429-a96e-441a-a3b2-a23d6115b3d7

Public Version Date

January 26, 2022

Public Version Number

3

DI Record Publish Date

June 20, 2018

Package DI Number

20851906007051

Quantity per Package

10

Contains DI Package

00851906007071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case