Exact Medical Manufacturing

Exact Medical Manufacturing specializes in single-use medical devices primarily focused on sterile barrier protection. Their products include patient surgical drapes, surgical gowns, body-surface ultrasound imaging transducer covers, medical equipment/instrument drapes, and face splash shields. These items are designed to maintain sterility and hygiene in surgical and procedural environments.

Exact Medical Manufacturing is based in the United States. Their headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available information.

Exact Medical Manufacturing’s devices are listed in the FDA’s regulatory databases, specifically under the 510(k) pathway for some products and the Unique Device Identification (UDI) system for others. These registries help track and authorize their Class I and Class II devices for use in medical settings.

Exact Medical Manufacturing’s devices fall under FDA Class I and Class II classifications. Class I devices generally pose the lowest risk and may require less regulatory oversight, while Class II devices involve moderate risk and typically require special controls to ensure safety and effectiveness. The specific classification depends on the device’s intended use and potential risks.

The FDA uses different pathways to authorize medical devices based on their risk level and intended use. Some of Exact Medical Manufacturing’s devices may require a 510(k) clearance because they are classified as Class II and need to demonstrate substantial equivalence to a legally marketed predicate device. Others may be listed under the UDI system if they are Class I devices with minimal risk or if they are part of a streamlined registration process for low-risk items. The UDI system helps track and identify devices throughout their lifecycle.