Surgical instrument handle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
12-11-2017
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Available from:
Mac Surgical
Class:
Class I
Manufactured by:
Mac Surgical 6 Roger Street, BROOKVALE, NSW, 2100 Australia
Therapeutic area:
47829 - Surgical instrument handle
Therapeutic indications:
A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument(eg., a screw driver shaft ) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or tensioning of a nut during a surgical procedure. The device is typically made of metal and?or synthetic material(eg., Polysulphone) It does not include a torque-limiting mechanism. This is a reusable device.
Authorization status:
A
Authorization date:
2012-01-05
