Device Dossier
Urological surgical procedure kit, non-medicated, single-use
Device Dossier for Urological surgical procedure kit, non-medicated, single-use (Urological surgical procedure kit, non-medicated, single-use, Class IIa,…
- GMDN category: Urological surgical procedure kit, non-medicated, single-use
Intended purpose
The iSR’obot Kit is intended to be used with the iSR’obot Mona Lisa 2.0 as a component of a system for performing transperineal prostate procedure. The kit consists of probe sheath, drape and biopsy papers. The probe sheath functions as a sheath to a third-party ultrasound probe for ultrasound scanning of the prostate organ. The drape is intended to cover the iSR’obot Mona Lisa 2.0 during the prostate procedure to prevent contamination. The biopsy papers are general laboratory paper materials to collect biopsy samples.