Distension unit,
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
17-11-2017
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Available from:
Promis Medical Australia Pty Ltd
Class:
Class I
Manufactured by:
Richard Wolf GmbH Pforzheimer strasse 32, Knittlingen, 75438 Germany
Therapeutic area:
38836 - Distension unit,
Therapeutic indications:
A device that is intended to distend a part of the body in order to provide a better viewing field for the surgeon (operator) and to provide better access to the body parts where a surgical intervention is to be undertaken. Distension is obtained with CO2 gas. Some units may also accommodate irrigation/aspiration functions for removal of tissue, debris, and fluid. This insufflator is used in hysteroscopy.
Authorization status:
A
Authorization date:
2008-07-30
