Syphon Fr 11/13 L 35cm

Primary DI

05906168942273

Basic UDI-DI Code

59061689422URO053L6

Reference

URO 053

Device Types

Single use Sterile Sterilization

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Wismed PL Sp. z o.o.

The Syphoning Ureteric Access Sheath (Syphon) compromises of three parts: a Syphon box (C), an access sheath (A), and a dilator (B). The syphon box compromises of sealing valves, and inflow and outflow channels. The sealing mechanism allows passage of other devices such as guidewire and ureteroscope with the added benefit of increased outflow and decreased intrarenal pressure. The access sheath is coated with ultra-slippery hydrogel and features a novel curved shape. The curve corresponds with the anatomy of the upper ureter and renal pelvis allowing the device to align along the axis of the upper urinary tract, enhancing visualization, and access to difficult to reach parts of the collecting system. The curvature of the device can be abolished by rotating the dilator inside the access sheath for insertion if required. The dilator is constructed of rigid clear shaft and soft white atraumatic tip with "dolphin nose" shape.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).