Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Sonita Medic Enterprises Pty Ltd - Laparoscopic grasping forceps, single-use
ARTG entry for
Medical Device Included Class IIa
Sonita Medic Enterprises Pty Ltd
PO Box 1289 Osborne Park Business Centre,OSBORNE PARK, WA, 6916
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.
Hunan Handlike Minimally Invasive Surgery Co
A4 Lugu Yuyuan #27 Wenxuan Rd High-tech
, Hunan, 410205
1. Laparoscopic grasping forceps, single-use
Single Device Product
61839 Laparoscopic grasping forceps, single-use
Cholangiogram clamping forceps used to grasp or compress a cannula during laparoscopic
cholangiography to (1) direct a cannula into the common bile duct via an incision made in the cystic duct
(2) Clamp the cystic duct around the cannula to prevent extravasation of X-ray contrast media. Single use
No Specific Conditions included on Record
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Produced at 03.11.2017 at 04:53:41 AEDT
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