Device Dossier
Flexible video ureteroscope, single-use
Device Dossier for Flexible video ureteroscope, single-use (Flexible video ureteroscope, single-use, Class IIa, sponsor Emergo). ARTG record, intended…
- GMDN category: Flexible video ureteroscope, single-use
Intended purpose
Intended purpose: The CoralView Single-Use Digital Flexible Ureteroscope is intended to be used with ViewHub video processor and other peripheral equipment to provide visualization during the observation, diagnostic and treatment within upper urinary tract and the interior of the kidney. Medical indications: Ureteral (upper urinary tract) stones and renal stones. Intended user: The device is intended to be used by professional. Intended patient population: Adult (including elderly person). Patient selection criteria: Patient over 18 years of age; and Patients with stones located upper urinary tract and kidney. Intended use environment: the endoscope is intended for use in a hospital environment.