Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
ConMed Linvatec Australia Pty Ltd - Sternum saw blade, single-use
ARTG entry for
Medical Device Included Class IIa
ConMed Linvatec Australia Pty Ltd
PO Box 6064, FRENCHS FOREST DC, NSW, 2086
ARTG Start Date
Medical Device Class IIa
- 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
- 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.
Gebr Brasseler GmbH & Co KG
Trophagener Weg 25
, Lemgo Deutschland, 32657
1 . Sternum saw blade, single-use
Single Device Product
44632 Sternum saw blade, single-use
A sterile, single-use, flat metal surgical cutting instrument with a serrated edge, designed for attachment to a dedicated powered
handpiece used for cutting the sternum (breastbone) during cardiovascular surgery. It is available in various configurations (e.g.,
with cutting teeth arranged in a straight line or arc along the cutting edge) and cuts when the blade is powered in a rapid
reciprocating movement (a back and forth motion like a jigsaw).
No Specific Conditions included on Record
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Produced at 22.07.2020 at 09:44:20 AEST
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