Foil - Agape - 10 mL - HMC

GUDID 10796494005955

Water-Based Personal Lubricant

CC Wellness LLC

Sexual lubricant

• Primary Device ID: 10796494005955
• NIH Device Record Key: 5494a323-cc11-4d1b-a105-3436262a6dd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Foil - Agape - 10 mL - HMC
• Version Model Number: 79063
• Company DUNS: 067692292
• Company Name: CC Wellness 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00796494005958 [Primary]
GS1	10796494005955 [Package]; Contains: 00796494005958; Package: [250 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171021

FDA Product Code

• NUC: Lubricant, Personal

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: 2025-04-29
• Device Publish Date: 2025-04-21

On-Brand Devices [Foil - Agape - 10 mL - HMC]

• 10796494005979: Water-Based Personal Lubricant
• 10796494005955: Water-Based Personal Lubricant