Summary for ARTG Entry:
Ozdent Pty Ltd - Protection equipment, radiation, apron
ARTG entry for
Medical Device Included Class 1
Ozdent Pty Ltd
PO Box 7806,BAULKHAM HILLS, NSW, 2153
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.
Flow X-ray Corp
100 West Industry Court
Deer Park, NY, 11729
United States Of America
1. Protection equipment, radiation, apron
Single Device Product
38355 Protection equipment, radiation, apron
A full or half-length apron-like garment intended to shield portions of the body of a patient, operator, or
other persons from exposure to radiation during medical or dental procedures. Some include attached or
detachable collars for neck and thyroid protection. The device typically consists of a fluid resistant outer
covering surrounding a thin sheet of lead or lead equivalent material. Those used for neutron attenuation
are composed of hydrogenous materials; those used in mixed beta-gamma radiation field may have layers
of both hydrogenous and lead equivalent materials.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:16:05 AEDT
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