Catalog Number

B098VHYX2M

Brand Name

Amazon Basics

Version/Model Number

B098VHYX2M

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 17, 2021

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

-

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

6289e5b8-0c25-41c8-bb62-7f047589d50f

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

October 27, 2021

Package DI Number

10195515017944

Quantity per Package

100

Contains DI Package

00195515017947

Package Discontinue Date

December 17, 2021

Package Status

Not in Commercial Distribution

Package Type

Case