Trojan BareSkin RAW

GUDID 80022600200020

For Contraception Plus STI Protection

CHURCH & DWIGHT CO., INC.

Basic male condom, Hevea-latex
Primary Device ID80022600200020
NIH Device Record Key25eae27c-1f27-4228-b7c1-13f523a2f2d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrojan BareSkin RAW
Version Model Number00022600200024
Company DUNS001211952
Company NameCHURCH & DWIGHT CO., INC.
Device Count24
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100022600200024 [Primary]
GS180022600200020 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HISCondom

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-11
Device Publish Date2021-05-03

On-Brand Devices [Trojan BareSkin RAW]

80022600200020For Contraception Plus STI Protection
80022600001535For Contraception Plus STI Protection

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.