Summary for ARTG Entry:
Kevin Grundy (IBD) Pty Ltd - Ossicular prosthesis introducer handpiece
ARTG entry for
Medical Device Included Class 1
Kevin Grundy (IBD) Pty Ltd
Suite 305 / 185 Elizabeth Street,St James Trust Building,SYDNEY, NSW, 2000
ARTG Start Date
Medical Device Class 1
- 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.
Grace Medical Inc
8500 Wolf Lake Drive Suite 110
Memphis, Tennessee, 38133
United States Of America
1. Ossicular prosthesis introducer handpiece
Single Device Product
60395 Ossicular prosthesis introducer handpiece
to direct/control the flow of air from an external surgical suction system to a fitted tip for
suction-lifting/manipulation of ossicular replacement components during implantation. It is a reusable
device intended to be sterilised prior to use
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:04:06 AEDT
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