Summary for ARTG Entry:
Karl Storz Endoscopy Australia Pty Ltd - Endoscope working-channel seal
ARTG entry for
Medical Device Included Class Is
Karl Storz Endoscopy Australia Pty Ltd
PO Box 50,LANE COVE, NSW, 1595
ARTG Start Date
Medical Device Class Is
- 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.
OBP Corporation dba OBP Medical
360 Merrimack Street Boulevard 9
Lawrence, MA, 01843
United States Of America
1. Endoscope working-channel seal
Single Device Product
60650 Endoscope working-channel seal
A sterile device intended to be fitted over the working channel access port of an endoscope to minimize
leakage of liquids and gases through the working channel, while permitting entry of endoscopic devices. It
is typically a small plastic Luer attachment with an intraluminal seal. This is a single-use device
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:46:53 AEDT
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