Atlas

GUDID 00850002174779

Atlas True Fit Latex Condom

LUNAMAX LLC

Basic male condom, Hevea-latex

• Primary Device ID: 00850002174779
• NIH Device Record Key: b5b461a0-82a1-4f25-a46b-85f3c11bf5b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atlas
• Version Model Number: GS191
• 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	00850002174779 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081886

FDA Product Code

• HIS: Condom

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-28
• Device Publish Date: 2018-11-27

On-Brand Devices [Atlas]

• 00850002174908: Atlas Blackjack Latex Condoms
• 00850002174779: Atlas True Fit Latex Condom