Eu Mdr Eu Md Class 1 On The Market 🇿🇦 South Africa

Mini Pillow

Wismed CC · 🇿🇦 South Africa
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
06009900408439
Basic UDI-DI Code
60099004083URO0523B
Reference
URO 052
Device Types
Single use Sterile
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market
Manufacturer
Wismed CC

Additional Description

Mini Pillow is a single use, sterile irrigation system that is used during Ureterorenoscopy and endoscopy. Irrigation during endoscopy helps to maintain a clear visual field by displacing blood, stone fragments, and cellular debris. The Mini Pillow is designed for controlled irrigation through an endoscope or accessory during urological and/or endoscopic procedures. The system is capable of producing dual flow i.e. background low intensity flow that is regulated by hydrostatic pressure by adjusting the height of the irrigation fluid reservoir and accelerated flow that depends on the force applied to the device by the hand of the operator. Lowering of the fluid reservoir below the patients’ level will cause background flow to cease Inadvertent effects, such as stone migration caused by pressurized irrigation can complicate Ureterorenoscopy but are easily avoided with the use of the Mini Pillow. The Mini Pillow clears visual field instantly with a flow that is effective even with laser fiber or basket loaded in the working channel and scope fully flexed. As a low volume system, it is less likely to subject the kidney to excessive intrapelvic pressures. Mini Pillow is operated by hand and due to its small size, it fits comfortably into the hand of the operator. The simple connection of the unit to the fluid supply provides the urologist with a very sensitive system capable of producing a broad range of flows, thus making both rigid and flexible ureteroscopy and stone treatment much easier.

CND Nomenclature Codes

Code Description
Z12019007 IRRIGATORS

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