CONTEMPO

GUDID 80070907695148

CONTEMPO ROUGH RIDER 8CT

SURETEX LIMITED - BRANCH

Basic male condom, Hevea-latex

• Primary Device ID: 80070907695148
• NIH Device Record Key: 7859eb51-cee4-4cda-8c99-87b81d575121
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONTEMPO
• Version Model Number: 0069
• Company DUNS: 672044515
• Company Name: SURETEX LIMITED - BRANCH
• Device Count: 8
• 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	00070907200698 [Primary]
GS1	80070907695148 [Unit of Use]

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: 2020-09-03
• Device Publish Date: 2020-08-26

On-Brand Devices [CONTEMPO]

• 80070907695186: CONTEMPO BARE RIDER 8CT
• 80070907695148: CONTEMPO ROUGH RIDER 8CT
• 80070907692574: CONTEMPO HOT RIDER