Australia - English - Department of Health (Therapeutic Goods Administration)

ecomed pty ltd - 32037 - light source, general-purpose - the device is intended for use as a general purpose examination luminaire/lighting, including uses for diagnosis, not for surgical use.

Australia - English - Department of Health (Therapeutic Goods Administration)

versalux pty ltd - 12276 - light, examination - luminaire for medical examination and diagnosis.

Australia - English - Department of Health (Therapeutic Goods Administration)

versalux pty ltd - 12276 - light, examination - luminaire for medical examination and diagnosis.

Australia - English - Department of Health (Therapeutic Goods Administration)

life healthcare pty ltd - 45199 - stereotactic surgery system, multi-purpose - the 7d surgical system is a stereotaxic image guided surgical navigation system. the system provides image registration between pre-operatively acquired tomographic data and data captured intra-operatively from the structured light imaging system. the system provides guidance data by displaying the locations of wireless optically tracked 7d cranial tracked navigation tools relative to the patient. position and orientation data of the tracked tools are linked to the preoperative scan data using the system's onboard computer. the system is intended to be used as the primary surgical luminaire for image guided surgery. the device is indicated for cranial surgery where reference to a rigid anatomical structure can be identified.

Australia - English - Department of Health (Therapeutic Goods Administration)

life healthcare pty ltd - 45199 - stereotactic surgery system, multi-purpose - the 7d surgical system is a stereotaxic image guided surgical navigation system. the system provides image registration between pre-operatively acquired tomographic data and data captured intra-operatively from the structured light imaging system. the system provides guidance data by displaying the locations of wireless optically tracked 7d spine kit tracked navigation tools relative to the patient. position and orientation data of the tracked tools are linked to the preoperative scan data using the system?s onboard computer. the system is intended to be used as the primary surgical luminaire for image guided surgery. the device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified relative to a model of the anatomy.

Australia - English - Department of Health (Therapeutic Goods Administration)

life healthcare pty ltd - 45169 - stereotactic surgery system probe, reusable - the 7d surgical system is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. the system is also intended to be used as the primary surgical luminaire during image guided surgery. the device is indicated for cranial surgery where reference to a rigid anatomical structure can be identified.

Australia - English - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 45199 - stereotactic surgery system, multi-purpose - a stereotaxic image guidance system intended for the spatial positioning and orientation of surgical instruments used by surgeons. the system is also intended to be used as the primary surgical luminaire during image-guided surgery.

Singapore - English - HSA (Health Sciences Authority)

dtg medical pte ltd - orthopaedics - the 7d surgical system percutaneous application is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. the system is also intended to be used as the primary surgical luminaire during image- guided surgery. the device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified.

Australia - English - Department of Health (Therapeutic Goods Administration)

mac surgical - 35528 - suction tip, fibreoptic illuminated, reusable - gmdns definition : suction tip, fibreoptic illuminated, reusable[35528] -------------------------------------------------------------------------------- a device that attaches to a suction instrument to control and direct suction during a surgical procedure or treatment. it will typically have a built-in fibreoptic light used to enhance visualization of the operative site. it may have an additional irrigation capability, e.g. a double lumen. this is a reusable device. primary code and term 35528 - suction tip, fibreoptic illuminated, reusable

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 38518 - suction tip, fibreoptic illuminated, single use - intended to provide suction, illumination and irrigation during medical procedures.