Summary for ARTG Entry:
William A Cook Australia Pty Ltd - Nephrostomy Tampanade Ballon Catheter - Balloon, intrauterine
ARTG entry for
Medical Device Included Class IIa
William A Cook Australia Pty Ltd
95 Brandl St Brisbane Technology Park,EIGHT MILE PLAINS, QLD, 4113
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.
750 Daniels Way
Bloomington, Indiana, 47404
United States Of America
1. Nephrostomy Tampanade Ballon Catheter - Balloon, intrauterine
Medical device system
12155 Balloon, intrauterine
The Nephrostomy Tamponade Balloon Catheter is used for nephrostomy drainage, ureteral drainage and
dynamic tamponade to prevent haemorrhage following nephrolithotomy and percutaneous stone removal
from tracts 18.0 French and larger. The set contains a stylet, balloon catheter, inflation check valve and
No Specific Conditions included on Record
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Produced at 10.11.2017 at 09:56:43 AEDT
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