STERITRACK UDI DOCUMENTATION PROCESS
SteriTrack provides a comprehensive, fully integrated hardware and software solution that provides rapid and accurate UDI tracking and documentation to assist you with inventory control, barcode validation, and gaining utilization reports and much more.
CURRENT UDI DOCUMENTATION PROCESS
The current tracking of medical devices and sterile implants relies upon error prone, manual data entry methods, with an ineffective way to capture UDI data.
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
EU MEDICAL DEVICE REGULATION
Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device. Learn More
BENEFITS FOR MANUFACTURERS
RECEIVE FULL TRACEABILITY
SteriTrack provides your organization the ability to scan and track all of your direct marked items with our Tractus™ scanner. Now you are able to receive greater visibility into your products and inventory. The SteriTrack philosophy is that a single scan should automatically parse and organize your UDI, and we would expect nothing less!
Our Tractus Software has an array of in-depth features designed to make inventory and instrument documentation simple and effective while giving you the power of robust reporting.
The Tractus Sterile Scanner is the world’s only patented scanning device that is able to accurately and quickly read direct part mark codes as small as 0.5mm^2 in less than a second.