Trojan Magnum XL Condom

GUDID 80022600647146

For Contraception Plus STI Protection

CHURCH & DWIGHT CO., INC.

Basic male condom, Hevea-latex

• Primary Device ID: 80022600647146
• NIH Device Record Key: 839e1fb4-f59a-4d2b-b43c-ece67f8f3b09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trojan Magnum XL Condom
• Version Model Number: 00022600002345
• Company DUNS: 001211952
• Company Name: CHURCH & DWIGHT CO., INC.
• Device Count: 10
• 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	00022600002345 [Primary]
GS1	80022600647146 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001212

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: 2020-04-17
• Device Publish Date: 2020-04-09

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