Catalog Number

-

Brand Name

Trojan Ecstasy Ultra Ribbed Lubricated Condom

Version/Model Number

00022600900238

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

K120286

Product Code

HIS

Product Code Name

CONDOM

Public Device Record Key

1a7f37b0-e0c5-4b41-ba37-7af1b92e3df2

Public Version Date

January 28, 2020

Public Version Number

1

DI Record Publish Date

January 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-