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.

STERILE SCANNING TECHNOLOGY

The Tractus™ Sterile Scanner is the only universal data collection system that can capture inventory utilization from direct part mark medical devices and implants in the sterile field.

Tractus™ benefits at the procedural setting:

The Tractus Sterile Scanner eliminates data communication errors in the OR caused by manual “call outs” of the UDI and drastically increases efficiency by providing an optimal UDI capture process.
The Tractus Sterile Scanner is able to ensure utilization accuracy, including implanted vs. discarded by sitting in the sterile field.
By sitting in the sterile field and synchronizes with the FDA’s GUDID and MAUDE databases, the Tractus Sterile Scanner is able to identify recalled or expired surgical implants and in return reducing the risk of jeopardizing patient safety.

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

OPTIMAL QUALITY ASSURANCE

Receive comprehensive and detailed quality reports on your direct part marked items with our Tractus™ code validator and verifier. This gives you the quality assurance necessary to know that your marks will scan at the point of use.

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UDI DOCUMENTATION OPTIMIZED

Our Tractus™ Sterile Scanner is the world’s first and only UDI scanning device that is able to quickly and easily read direct part mark codes in less than a second in and out of the procedural setting.

Tractus Sterile Scanner Benefits

Captures all medical devices and supplies during surgery (whether packaged or in sets and trays).
Sterile Field Scanners collect hospital-sterilized implant UDIs from DM data matrix codes as small as 0.5mm^2 in less than one second.
Guards against dangerous counterfeits by allowing manufacturers to create device pedigrees that may be traced through the supply chain.

SOLUTIONS FOR ALL ENVIRONMENTS

MANUFACTURERS

See how the SteriTrack and our suite of universal UDI capture products can make your OR even more efficient and compliant.

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HEALTHCARE

Control inventory, validate barcodes, get utilization reports and much more, see what immediate value our solution can provide.

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PAYOR’S

We develop products that help you manage recalls, perform analytical reports on implants, instruments, and surveillance.

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LET’S WORK TOGETHER

The team at SteriTrack is here to solve your UDI and surgical inventory documentation challenges, reach out today.

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