Syphon Fr 11/13 L 45cm

Organization name

Calyx Medical Sp. z o.o.

SRN

PL-MF-000038787

Manufacturer status

Active

Primary placement in Poland; available across 1 country total.

Trade name

Syphon Fr 11/13 L 45cm

UDI-DI code

05906168942280

Basic UDI-DI

59061689422URO054L8

Reference / catalog number

URO 054

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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European Medical Device Nomenclature — the EU product classification assigned to this device.

• A03010202UROLOGICAL IRRIGATION CONTROLLERS