Catalog Number

-

Brand Name

Trojan™ The Edge Changing Sensations Condom

Version/Model Number

00022600016519

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

K120287,K912901,K120287,K912901

Product Code

HIS

Product Code Name

CONDOM

Public Device Record Key

384298a9-d16e-44b7-a61f-b796b6fb3849

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-