Gen X - Procreate - 4 oz

GUDID 10796494002657

Fertility-Friendly Water-based Personal Lubricant - Unscented

CC Wellness LLC

Sexual lubricant

• Primary Device ID: 10796494002657
• NIH Device Record Key: 97c902df-da32-464a-832e-a8aad18a0dae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gen X - Procreate - 4 oz
• Version Model Number: 74010
• 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	00796494002650 [Primary]
GS1	10796494002657 [Package]; Contains: 00796494002650; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212705

FDA Product Code

• PEB: Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

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: 2023-05-22
• Device Publish Date: 2023-05-12

Devices Manufactured by CC Wellness LLC

• 10796494005573 - JO - Foil - Agape - 5mL - HMC: 2025-02-17 Water-Based Personal Lubricant
• 10796494005580 - JO - Foil - Coconut Hybrid - 5mL - HMC: 2025-02-17 Hybrid-Based Personal Lubricant
• 10796494005597 - Pure Romance - Water-Based Personal Lubricant Original - 5mL: 2025-02-17 Water-Based Personal Lubricant
• 10796494005603 - Pure Romance - Water-Based Personal Lubricant Watermelon - 5mL: 2025-02-17 Water-Based Personal Lubricant
• 10796494005542 - JO - Foil - Gelato - Decadent Double Chocolate - 5mL - HMC: 2025-02-10 Water-Based Personal Lubricant
• 10796494005559 - JO - Foil - H2O Original - 5mL - HMC: 2025-02-10 Water-Based Personal Lubricant
• 10796494005504 - JO - Foil - Premium - 5mL - HMC: 2025-01-22 Silicone-Based Personal Lubricant
• 10796494005511 - JO - Foil - H2O Watermelon - 5mL - HMC: 2025-01-22 Water-Based Personal Lubricant