Catalog Number

-

Brand Name

Flex Disc

Version/Model Number

10018

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

7fd255c3-e8a9-4163-945a-b1492adeee2f

Public Version Date

March 22, 2022

Public Version Number

1

DI Record Publish Date

March 14, 2022

Package DI Number

10850037498007

Quantity per Package

3

Contains DI Package

00850037498000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack