Catalog Number

-

Brand Name

Flex

Version/Model Number

Box of Flex 12 count (English only) VERTICAL

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

72b2a523-59db-4051-80bb-78cad4091a4a

Public Version Date

January 26, 2022

Public Version Number

3

DI Record Publish Date

March 15, 2019

Package DI Number

10851906007245

Quantity per Package

18

Contains DI Package

00851906007248

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case