Contempo

GUDID 00850002174915

Contempo Rough Rider Latex Condom

LUNAMAX LLC

Basic male condom, Hevea-latex

• Primary Device ID: 00850002174915
• NIH Device Record Key: ce01b360-c8bb-4492-9d78-2a61320f38bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Contempo
• Version Model Number: GS221
• Company DUNS: 106855461
• Company Name: LUNAMAX LLC
• Device Count: 1
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850002174915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941258

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: 2019-02-18
• Device Publish Date: 2019-01-16

Devices Manufactured by LUNAMAX LLC

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• 00850002174106 - Crown: 2019-02-18 Crown Original Latex Condom
• 00850002174113 - Crown: 2019-02-18 Crown Colors/Colored Latex Condom
• 00850002174137 - Lifestyles: 2019-02-18 Lifestyles Ultra Lubricated with Spermicide Latex Condom
• 00850002174502 - Lifestyles: 2019-02-18 Lifestyles Tuxedo Latex Condom
• 00850002174519 - Beyond Seven: 2019-02-18 Beyond Seven Ultra Thin Latex Condom
• 00850002174526 - Beyond Seven: 2019-02-18 Beyond Seven Ultra Thin Latex Condom