JO Agape - Original - Lubricant 2 floz / 60 mL

GUDID 10796494001025

Water-Based Personal Lubricant

CC Wellness LLC

Sexual lubricant

• Primary Device ID: 10796494001025
• NIH Device Record Key: 63c9f465-ef38-4da7-83be-4e682dc14f7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JO Agape - Original - Lubricant 2 floz / 60 mL
• Version Model Number: 42008
• 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: false
• 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	00796494001028 [Primary]
GS1	10796494001025 [Package]; Contains: 00796494001028; Package: [12 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: 2022-09-22
• Device Publish Date: 2022-09-14

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