Sterilance Medical (usa), Inc.

Sterilance Medical (USA), Inc. specializes in single-use blood lancets, such as the ONETOUCH UltraSoft 2. These devices are designed for skin puncture procedures, primarily used in blood glucose monitoring and other diagnostic applications requiring minimal tissue trauma.

Sterilance Medical (USA), Inc. is based in the United States. The company’s focus on domestic manufacturing aligns with its regulatory and operational structure for medical devices.

Sterilance Medical’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for Class II devices, which include their blood lancets.

Sterilance Medical’s blood lancets fall under the FDA’s Class II regulatory category. This classification applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.