Our Tractus™ Sterile Scanner is the world’s first and only UDI scanning solution that is able to quickly and accurately read UDI data on ALL medical devices during surgery, including hospital sterilized implants.
REGULATORY COMPLIANCE ENSURED
Meeting regulatory compliance requirements is critical for your organization. SteriTrack is focused on delivering solutions that provide peace of mind and help ensure you are your organization is compliant.
FDA UDI REQUIREMENTS
If a UDI is required on a device label, that device is also required to have a UDI permanently affixed to the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. This requirement applies to all device classes, except class I devices that bear a Universal Product Code (UPC) on their label and device packages. Learn More
OPTIMAL QUALITY ASSURANCE
Receive comprehensive and detailed quality reports on your direct part marked items with our Tractus™ code validator. This gives you the quality assurance necessary to know that your marks will scan at the point of use.