GUY & O'NEILL, INC.

Guy & O’Neill, Inc. specializes in personal lubricants intended for intimate use. These include water-based and silicone-based formulations, often sold in single-use applicators or multi-use bottles under brand names like Evoke and Equate. Their products are designed to enhance comfort and safety during intimate activities.

Guy & O’Neill, Inc. is headquartered in the United States. Since their devices are regulated under U.S. medical device laws, their classification and compliance requirements follow FDA guidelines, including mandatory listing in the FDA’s Unique Device Identifier (UDI) database.

Guy & O’Neill, Inc.’s personal lubricants fall under Class II medical device classification in the U.S. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general good manufacturing practices to ensure safety and effectiveness.

Yes, Guy & O’Neill, Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This database is part of the FDA’s efforts to improve device tracking, transparency, and post-market surveillance by assigning a unique identifier to each distinct device.