Catalog Number

-

Brand Name

Flex

Version/Model Number

10150

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

153bbcdb-6cfe-4ef2-b596-022bd456d29e

Public Version Date

September 14, 2022

Public Version Number

1

DI Record Publish Date

September 06, 2022

Package DI Number

20851906007716

Quantity per Package

3

Contains DI Package

00851906007712

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-