Trojan Enz

GUDID 00726893112537

Condom For Contraception Plus STI Protection

CHURCH & DWIGHT CO., INC.

Basic male condom, Hevea-latex

• Primary Device ID: 00726893112537
• NIH Device Record Key: d3047d60-b58a-4ca0-ba1d-804a376edeff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trojan Enz
• Version Model Number: 00726893112537
• Company DUNS: 001211952
• Company Name: CHURCH & DWIGHT CO., INC.
• Device Count: 3
• 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

Customer Support Contacts

• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00726893112537 [Primary]
GS1	80022600900012 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092586

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: 2020-01-10
• Device Publish Date: 2020-01-02

On-Brand Devices [Trojan Enz]

• 00726893112544: Condom For Contraception Plus STI Protection
• 00726893112537: Condom For Contraception Plus STI Protection