Catalog Number

-

Brand Name

Flex

Version/Model Number

Box of Flex 8 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

d41f977f-b093-4a2e-80d4-6c398e5d958a

Public Version Date

January 26, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

10851906007054

Quantity per Package

24

Contains DI Package

00851906007057

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case