Catalog Number

-

Brand Name

Oi

Version/Model Number

Large

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

-

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

8db64e12-ee87-40f8-8131-068f09ed2893

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

April 02, 2020

Package DI Number

09421904034297

Quantity per Package

6

Contains DI Package

09421904034266

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master carton