Catalog Number

-

Brand Name

Flex Plant+ Menstrual Disc

Version/Model Number

10128

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"

Yes

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

7cdf84df-2b03-457a-94a8-1f0ce7f952f8

Public Version Date

January 27, 2022

Public Version Number

1

DI Record Publish Date

January 19, 2022

Package DI Number

10851906007627

Quantity per Package

2

Contains DI Package

00851906007620

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner pack