Summary for ARTG Entry:
Medical & Optical Instruments Australia Pty Ltd - Universal hand-controlled electrosurgical diathermy
system conducting unit, reusable
ARTG entry for
Medical Device Included Class IIb
Medical & Optical Instruments Australia Pty Ltd
PO Box 850,ARTARMON, NSW, 1570
ARTG Start Date
Medical Device Class IIb
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Kirwan Surgical Products Inc
180 Enterprise Drive
Marshfield, MA, 02050
United States Of America
1. Universal hand-controlled electrosurgical diathermy system conducting unit, reusable
Single Device Product
42552 Universal hand-controlled electrosurgical diathermy system conducting unit, reusable
A reuseable electrode handpiece intended to provide an electrical connection between an electrosurgical
generator and a patient. The electrical power switch for this device is part of the electrode and allows the
surgeon to hand control the unit.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 07:07:33 AEDT
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