Dornier Medilas Laser System

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

제공처:

Dornier Medtech Asia Pte Ltd

수업:

Class C medical device

Manufactured by:

Dornier MedTech GmbH

치료 영역:

Gastroenterology & Urology

치료 징후:

The Dornier Medilas H140/ Dornier Medilas H100 Laser is intended for use for surgical procedures soft tissue cutting, ablation, coagulation and vaporization and hard tissue fragmentation in the following medical specialties: UROLOGY HoLEP (Holmium Laser Enucleation of the Prostate), Urethrotomy (Treatment of Urethral Strictures), Bladder neck incision (BNI) and Coagulation. URINARY LITHOTRIPSY Endoscopic fragmentation and pulverization of urethral, ureteral, bladder and renal stones. GASTROENTEROLOGY Endoscopic fragmentation and pulverization of biliary/ bile duct calculi. The morcellator is intended solely for transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate.

제품 요약:

Device System Info:[System or Procedure Pack], [Sterile Medical Device], Dornier Medilas H140/ Dornier Medilas H100 system consists of laser machine, morcellator blade and kit and fiber. Bare Fibers are sterilized by EO.; Models: Handpiece Morcellator - K2015210, Morcellator Blade 350MM - K2015211, Morcellator Blade 400MM - K2015212, Morcellator Blade Cleaning Adapter - K2015213, Bare Fiber - K2015217, Bare Fiber - K2015218, Bare Fiber - K2015219, Bare Fiber - K2015220, Bare Fiber - K2015221, Bare Fiber - K2015222, Bare Fiber - K2015223, Bare Fiber - K2015224, Bare Fiber - K2015744, Bare Fiber - K2015745, Handpiece Medilas H Morcellator - K2015785, Morcellator Blade 350 - K2015786, Morcellator Blade 400 - K2015787, Aspiration Tube Set Morcellator 1C - K2015214, Morcellator GEN 2 Blade Reprocessing Kit - K2016206, Adapter for Peristaltic Pump - K2015215, Holder Tissue Waste container - K2015251, Footswitch - K2015405, Tissue Waste Container - K2015216, Dornier Medilas H140 - K2015000, Dornier Medilas H 140 - K2014800, Dornier Medilas H 100 - K2015500, Dornier SingleFlex® 200 High Energy - K2015435, Dornier SingleFlex® 270 High Energy - K2015437, Dornier SingleFlex® 400 High Energy - K2015439, Dornier SingleFlex® 600 High Energy - K2015441, Dornier SingleFlex® 1000 High Energy - K2015443, Dornier GentleFlex® 200 - K2016478

승인 날짜:

2020-01-24