Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Palette Life Sciences Australia Pty Ltd - Barrigel - Radiotherapy protection spacer
ARTG entry for
Medical Device Included Class III
Palette Life Sciences Australia Pty Ltd
PO Box 506, Narrabeen, NSW, 2101
ARTG Start Date
Medical Device Class III
- 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.
Palette Life Sciences
27 E Cota Street Suite 402
Santa Barbara, CA, 93101
United States Of America
1 . Barrigel - Radiotherapy protection spacer
Single Device Product
60424 Radiotherapy protection spacer
Barrigel is a sterile, transparent, biodegradable gel of stabilized hyaluronic acid of non-animal origin, supplied in a glass syringe.
Barrigel acts by adding volume to the tissue, thereby mechanically creating an increased distance between the prostate and the
anterior rectal wall. The product degrades over time.
Barrigel is used to increase the distance between the prostate and the anterior rectal wall, with the intent to decrease radiation dose
delivered to the rectum when treating prostate cancer with radiation.
Nil variant (as 1 device) 3mL
No Specific Conditions included on Record
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Produced at 22.07.2020 at 07:58:56 AEST
This is not an ARTG Certificate document.
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