Caution Wear

GUDID 00850002174687

Caution Wear Grande Latex Condom

LUNAMAX LLC

Basic male condom, Hevea-latex

• Primary Device ID: 00850002174687
• NIH Device Record Key: 2ce39d38-64a1-4448-a9d2-0b0450fbaed0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Caution Wear
• Version Model Number: GS201
• 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	00850002174687 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012964

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 [Caution Wear]

• 00850002174687: Caution Wear Grande Latex Condom
• 00850002174205: Caution Wear Iron Grip Latex Condom
• 00850002174199: Caution Wear Iron Grip Latex Condom