Summary for ARTG Entry:
Karl Storz Endoscopy Australia Pty Ltd - Surgical video telescope, sterilizable
ARTG entry for
Medical Device Included Class 1
Karl Storz Endoscopy Australia Pty Ltd
PO Box 50,LANE COVE, NSW, 1595
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.
Karl Storz GmbH & Co KG
TUTTLINGEN, Tuttlingen, D 78532
1. Surgical video telescope, sterilizable
Single Device Product
60491 Surgical video telescope, sterilizable
An optical device intended to be used as part of a surgical video telescope system to send magnified
images of a surgical site, via a camera and appropriate hardware, to a monitor to facilitate visualization of
the surgical site by the surgeon or for teaching applications. It is typically a housing containing a distal
lens, fibreoptic cabling, and an illumination port. It is intended to be fixed (using a positioning arm) at an
appropriate distance from the surgical site (e.g., 25-75cm), and is not intended to contact the patient. This
is a reusable device intended to be sterilized prior to use.
No Specific Conditions included on Record
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