UNITED UROLOGICS INC

United Urologics Inc specializes in single-use medical devices primarily focused on urinary drainage. Their products include single-administration urethral catheterization kits and urethral catheterization support kits, specifically designed for one-time use. These devices are intended to reduce the risk of contamination during catheterization procedures by maintaining a closed system.

United Urologics Inc is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards, which govern the design, manufacturing, and distribution of its medical devices.

United Urologics Inc’s devices are classified as Class II under U.S. medical device regulations. This classification applies to products that pose moderate risk and require special controls to ensure their safety and effectiveness, such as closed system catheters, which help prevent urinary tract infections during catheterization.

Yes, United Urologics Inc’s devices are listed in the FDA’s Unique Device Identification (UDI) database. The UDI system helps track and trace medical devices throughout their lifecycle, ensuring transparency in the supply chain and aiding in post-market surveillance efforts.

The primary purpose of United Urologics Inc’s devices is to facilitate safe and hygienic urinary drainage. Their single-use closed system catheters and catheterization kits are designed to minimize the risk of infection by preventing contamination during catheterization procedures, which is critical in clinical settings where infection control is paramount.