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

brainlab australia pty ltd - 62380 - surgical instrument assist arm system, power-adjusted - the device assists in maintaining spatial positioning of instruments during

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

brainlab australia pty ltd - 62380 - surgical instrument assist arm system, power-adjusted - the device assists in maintaining spatial positioning of instruments during surgical procedures

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

brainlab australia pty ltd - 62783 - electromagnetic/optical surgical navigation device tracking system - the devices are intended to support surgical instrument guidance during navigated surgical procedures.

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

brainlab australia pty ltd - 40885 - radionuclide system, therapeutic, stereotactic radiosurgery, application program software - the software uses digital bioimaging to support treatment planning. the software is intended as a planning software to pre- and intra-operatively plan surgeries. it displays digital bioimaging and allows measurement of the images and allows planning of implants of different dimensions and in various positions.

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

brainlab australia pty ltd - 60724 - medical image management system application software - the device software is intended to load patient data, start applications, transfer patient data and video signals between connected systems and export data

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

brainlab australia pty ltd - 62783 - electromagnetic/optical surgical navigation device tracking system - the device is intended to achieve a rigid fixation to the patient skull in order to enable patient tracking when used in combination with brainlab image guided surgery (igs) software.

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

brainlab australia pty ltd - 62783 - electromagnetic/optical surgical navigation device tracking system - the device is intended to achieve a rigid fixation to the patient skull in order to enable patient tracking when used in combination with brainlab image guided surgery (igs) software.

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

brainlab australia pty ltd - 13836 - stylet, needle - used in combination with pedicle access needle guide tube to perforate the cortical bone of the pedicle until it is introduced in the vertebral body.

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

brainlab australia pty ltd - 63570 - intracranial catheter navigation transmitter stylet - the em disposable stylet is a pre-calibrated electro-magnetically (em) tracked guide wire for navigated placement of intracranial catheters or shunts in neurosurgery with the aid of the brainlab cranial em navigation system. it is flexible and has one sensor coil placed at its distal end, ensuring accurate tracking of its tip position. further the stylet can be used as an intracranial pointer device during craniotomy / craniectomy for navigation of anatomical landmarks. the device enables intracranial placement of catheters / shunts and stereotactic localization in neurosurgery.

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

brainlab australia pty ltd - 33968 - screwdriver, surgical - the hex screwdriver is designed to manually apply torque to screws and/or nuts of appropriate size. the hex screwdriver is applied together with instruments and used to attach/detach instruments to/from a patient, or to attach/detach an instrument to/from another instrument and therefore enabling an instrument to be used with compatible brainlab and 3rd party navigated surgery applications. the hex screwdriver is reusable and must be sterilized resp. reprocessed before use.