Trojan BareSkin RAW

GUDID 80022600200020

For Contraception Plus STI Protection

CHURCH & DWIGHT CO., INC.

Basic male condom, Hevea-latex

• Primary Device ID: 80022600200020
• NIH Device Record Key: 25eae27c-1f27-4228-b7c1-13f523a2f2d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trojan BareSkin RAW
• Version Model Number: 00022600200024
• Company DUNS: 001211952
• Company Name: CHURCH & DWIGHT CO., INC.
• Device Count: 24
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00022600200024 [Primary]
GS1	80022600200020 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192669

FDA Product Code

• HIS: Condom

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-11
• Device Publish Date: 2021-05-03

On-Brand Devices [Trojan BareSkin RAW]

• 80022600200020: For Contraception Plus STI Protection
• 80022600001535: For Contraception Plus STI Protection