Catalog Number

-

Brand Name

ONE Pleasure Plus

Version/Model Number

110302

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

658188de-6e06-43cc-a8b6-d1faf9fd9da5

Public Version Date

June 09, 2020

Public Version Number

1

DI Record Publish Date

June 01, 2020

Package DI Number

10726893110431

Quantity per Package

3

Contains DI Package

00726893110434

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

bundle of 3, 12 pack