RIDER

GUDID 30070907298580

LIFESTYLES MEGA RIDER

SURETEX LIMITED - BRANCH

Basic male condom, Hevea-latex

• Primary Device ID: 30070907298580
• NIH Device Record Key: c276cb04-b87e-4b5a-958a-48d7c3e1d0de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIDER
• Version Model Number: 9858
• Company DUNS: 672044515
• Company Name: SURETEX LIMITED - BRANCH
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00070907298589 [Primary]
GS1	10070907298586 [Package]; Contains: 00070907298589; Package: inner [6 Units]; In Commercial Distribution
GS1	30070907298580 [Package]; Contains: 10070907298586; Package: case [24 Units]; In Commercial Distribution
GS1	80070907695162 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001883

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: 2019-09-03
• Device Publish Date: 2019-08-26

On-Brand Devices [RIDER]

• 30070907298603: LIFESTYLES ROUGH RIDER 3CT
• 30070907298597: LIFESTYLES SWEET RIDER 3CT
• 30070907298580: LIFESTYLES MEGA RIDER
• 30070907298573: LIFESTYLES BARE RIDER 3CT
• 30070907298566: LIFESTYLES WET RIDER
• 30070907298559: LIFESTYLES HOT RIDER