LOLA

GUDID 10850038563155

FRMBR1-LZ3-CW3SX

FORUM BRANDS, LLC

Basic male condom, Hevea-latex

• Primary Device ID: 10850038563155
• NIH Device Record Key: dea89613-0e5e-4898-8656-3e387352c7f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOLA
• Version Model Number: 24CT Large (55mm) Ultra Thin Condoms
• Company DUNS: 055659749
• Company Name: FORUM BRANDS, LLC
• Device Count: 24
• 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: true
• 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	00850038563158 [Primary]
GS1	00851617007674 [Unit of Use]
GS1	10850038563155 [Package]; Contains: 00850038563158; Package: Master Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K896987

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: 2024-09-06
• Device Publish Date: 2024-08-29

On-Brand Devices [LOLA]

• 00851617007339: 24ct Ultra Thin Lubricated Condoms
• 10850038563155: FRMBR1-LZ3-CW3SX
• 10810092259388: FRMBR1-LZ3-C75SC