Catalog Number

-

Brand Name

Trojan™ Premium Latex Condoms Magnum™ Large Size Condoms

Version/Model Number

00022600642039

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)

-

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

K895640,K895640

Product Code

HIS

Product Code Name

CONDOM

Public Device Record Key

3e9a4865-78fb-4a8e-bbc3-1b5ad74ae07f

Public Version Date

October 22, 2021

Public Version Number

4

DI Record Publish Date

October 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-