Catalog Number

-

Brand Name

ONE Vanish Hyperthin

Version/Model Number

111302

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)

Yes

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

14963221-3874-4404-9b90-c38dbd9d6779

Public Version Date

April 21, 2022

Public Version Number

2

DI Record Publish Date

June 15, 2020

Package DI Number

10726893111308

Quantity per Package

3

Contains DI Package

00726893111301

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bundle of 3, 12 pack