Helmet, surgical, system
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
12-11-2017
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Available from:
Surgical Specialties Pty Ltd
Class:
Class I
Manufactured by:
THI Total Healthcare Innovation GmbH Gewerbestrasse 4, Feistritz im Rosental, 9181 Austria
Therapeutic area:
35102 - Helmet, surgical, system
Therapeutic indications:
A system intended for the purpose of protecting healthcare workers and patients from cross-infection during surgery. It is composed of a helmet frame, inflow and exhaust fans and and a battery pack to drive the internal ventilation. It is intended for use with a loose fitting disposable hood (available separately).
Authorization status:
A
Authorization date:
2012-07-10
