Australia - engelsk - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Australian Pacific Medical Pty Ltd - Sterile fluted surgical drill
ARTG entry for
Medical Device Included Class IIa
Australian Pacific Medical Pty Ltd
1 Clanalpine Street,EASTWOOD, NSW, 2122
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 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.
Shanghai Bojin Medical Instruments Co Ltd
A Zone of F2 C Zone of F1 Building 6 No 125
Jiading District, Shanghai, 201801
1. Sterile fluted surgical drill
Single Device Product
43390 Sterile fluted surgical drill
A sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to
create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist
drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that
extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power
tool or a surgical hand drill/brace. It is typically made of high-grade stainless steel and is available in
various sizes. This is a single-use device.
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Produced at 02.11.2019 at 06:14:14 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
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