Catalog Number

-

Brand Name

Trojan Magnum Gold Collection

Version/Model Number

00022600019879

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,K140379,K895640,K120286,K140379,K895640

Product Code

HIS

Product Code Name

CONDOM

Public Device Record Key

9def15c0-3c73-4103-9785-dc621814b829

Public Version Date

March 22, 2019

Public Version Number

1

DI Record Publish Date

March 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-