Lifestyles

GUDID 00850002174083

Lifestyles SKYN Large Polyisoprene/Synthetic Condom

LUNAMAX LLC

Basic male condom, synthetic polymer

• Primary Device ID: 00850002174083
• NIH Device Record Key: b095254c-b269-4aa5-907f-d5b866f2e373
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lifestyles
• Version Model Number: GS111
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850002174083 [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: 2019-02-18
• Device Publish Date: 2019-01-16

On-Brand Devices [Lifestyles]

• 00850002174946: Lifestyles Colors Latex Condom
• 00850002174816: Lifestyles Ultra Lubricated Latex Condoms
• 00850002174809: Lifestyles Ultra Sensitive Latex Condom
• 00850002174793: Lifestyles Ultra Lubricated with Spermicide Latex Condom
• 00850002174632: Lifestyles Ultra Thin Latex Condom
• 00850002174625: Lifestyles Pleasure Ribbed Latex Condom
• 00850002174502: Lifestyles Tuxedo Latex Condom
• 00850002174496: Lifestyles KYNG Latex Condom
• 00850002174489: Lifestyles KYNG Latex Condom
• 00850002174274: Lifestyles Extra Strength Latex Condom
• 00850002174267: Lifestyles Non Lubricated Latex Condom
• 00850002174212: Lifestyles Snugger Fit Latex Condom
• 00850002174151: Lifestyles Snugger Fit Latex Condom
• 00850002174137: Lifestyles Ultra Lubricated with Spermicide Latex Condom
• 00850002174083: Lifestyles SKYN Large Polyisoprene/Synthetic Condom
• 00850002174076: Lifestyles SKYN Large Polyisoprene/Synthetic Condom
• 00850002174038: Lifestyles SKYN Polyisoprene/Synthetic Condom
• 00850002174021: Lifestyles SKYN Polyisoprene/Synthetic Condom
• 00850002174014: Lifestyles Tuxedo Latex Condom
• 00850002174007: Lifestyles Ultra Sensitive Latex Condom