Surgivisio Device I00001

The Surgivisio Device is explicitly designed for single-use only. The specifications confirm it is non-reusable (REUSABLE: 0), meaning it must not be reprocessed, cleaned, or sterilized for subsequent procedures. This ensures patient safety and maintains device integrity as intended by the manufacturer.

While the data does not specify exact storage conditions, the manufacturer’s guidelines (referenced in the description) must be followed to preserve functionality and safety. Since it is a non-sterile (STERILE: 0) and single-use device, it should be stored in its original packaging, protected from physical damage, extreme temperatures, and contamination until use. Always adhere to the manufacturer’s instructions to avoid compromising performance.

The provided data does not detail specific sizes, models, or configurations of the Surgivisio Device. It is classified under nomenclature code Z12130401 as a general-purpose surgical robot for minimally invasive procedures, but no variations (e.g., arm lengths, attachments, or modular components) are mentioned. For exact configurations, consult the manufacturer’s product documentation or catalog.

The Surgivisio Device does not claim to be latex-free (LATEX: 0), meaning it may contain latex or latex-derived materials. Clinicians or facilities with latex allergies or restrictions should verify compatibility with the manufacturer or use appropriate precautions, such as latex-free gloves, when handling or operating the device.

Each Surgivisio Device carries a Basic UDI (B-03701311500407) and associated UDI data (e.g., ULID: 01FNXMXE05SGC6CR6WTX8000M1). The UDI is crucial for traceability, inventory management, and compliance with regulatory requirements. It ensures accurate tracking of the device’s origin, batch, and expiration—especially important for single-use items like this one—to prevent mix-ups or misuse. Always check the UDI label for verification.