Contodo LLC

Contodo LLC specializes in surgical and examination garment kits, radiopaque woven sponges (used for visibility during imaging procedures), and non-antimicrobial woven gauze pads. These devices are designed for sterile or clean field applications in operating rooms, procedural settings, and patient care environments where hygiene and visibility are critical.

Contodo LLC is headquartered in the United States. The company’s devices are developed and distributed in compliance with applicable U.S. regulatory standards, including those governing Class I and Class II medical devices. While the company adheres to these requirements, individual device authorizations depend on FDA review and clearance processes.

Yes, Contodo LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I and Class II devices, allowing healthcare providers and regulators to identify and track specific products through standardized identifiers.

Contodo LLC’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls or performance standards. The classification determines the regulatory pathway for each device’s authorization.