Catalog Number

-

Brand Name

DUREX Pleasure Ring

Version/Model Number

Penile Rigidity Ring

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

LKY

Product Code Name

Device, external penile rigidity

Public Device Record Key

8c393e97-3b2d-45eb-a644-80eb0f293b18

Public Version Date

October 17, 2019

Public Version Number

6

DI Record Publish Date

September 20, 2016

Package DI Number

10067981957522

Quantity per Package

3

Contains DI Package

00067981957525

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton