Catalog Number

-

Brand Name

Trojan Supra™ Premium Condoms Non-Latex Bareskin™

Version/Model Number

00022600902201

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

K050828,K100767,K050828,K100767

Product Code

MOL

Product Code Name

Condom, synthetic

Public Device Record Key

310ee7c5-602f-4baa-91a3-48a88f9bc631

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-