Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
ACRA Regulatory Services Pty Ltd - Bone tap
ARTG entry for
Medical Device Included Class IIa
ACRA Regulatory Services Pty Ltd
7/84 Poincina Avenue, Tewantin, QLD, 4565
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.
83 South Commerce Way Suite 310
Bethlehem, Pennsylvania, 18017
United States Of America
1 . Bone tap
Single Device Product
17507 Bone tap
Surgical instrument intended to be used during implantation of an orthopaedic prosthesis. This is a single use device intended to be
sterilized prior to use.
No Specific Conditions included on Record
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Produced at 22.07.2020 at 08:22:49 AEST
This is not an ARTG Certificate document.
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