LifeStyles SKYN Large 40 ct Bowl

GUDID 00813356000217

PARADISE MARKETING SERVICES, A CALIFORNIA CORPORATION

Basic male condom, synthetic polymer Basic male condom, synthetic polymer

• Primary Device ID: 00813356000217
• NIH Device Record Key: 1c26946b-8e26-45a4-b05b-1d3b619b85b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifeStyles SKYN Large 40 ct Bowl
• Version Model Number: 813356000217
• Company DUNS: 038573838
• Company Name: PARADISE MARKETING SERVICES, A CALIFORNIA CORPORATION
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813356000217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160399

FDA Product Code

• MOL: Condom, Synthetic

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: 2019-01-21
• Device Publish Date: 2018-12-21

Devices Manufactured by PARADISE MARKETING SERVICES, A CALIFORNIA CORPORATION

• 00813356000040 - Paradise Slim Fit Condoms Strips 1000s: 2019-07-16
• 00813356000057 - Paradise Slim Fit Condoms 40 ct bowl: 2019-07-16
• 00813356000002 - Paradise Lubricated Condoms Strips 1000s: 2019-07-03
• 00813356000019 - Paradise Lubricated Condoms 40 ct bowl: 2019-07-03
• 00813356000033 - Lifestyles Rough Rider Studded 40 ct Bowl: 2019-05-01
• 00813356000125 - Trojan Enz 40 ct Bowl: 2019-03-11
• 00813356000132 - Trojan Magnum 40 ct Bowl: 2019-03-11
• 00813356000026 - Lover Covers Condoms 40 ct bowl: 2019-01-21