Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 46355 - electrophysiology cardiac catheter, single-use - the device have an insulated polymer shaft with platinum electrodes located along the distal section of the shaft. the fixed curve diagnostic catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

midmed pty ltd - 38501 - insulin syringe, fixed-needle - intended to be used to administer an injection of insulin to a patient subcutaneously.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

multigate medical devices pty ltd - 38501 - insulin syringe, fixed-needle - a sterile syringe with needle intended to administer medication with an accurate metered dosage.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

cathrx pty ltd - 46355 - electrophysiology cardiac catheter, single-use - the device is designed to facilitate electrophysiological mapping of the heart. it consists of a shaft with a distal loop containing an array of platinum-iridium electrodes for stimulation and recording. the device is available in a number of different electrode configurations and loop diameters. the loop diameter and curve shape of the catheter tip are fixed. the device is indicated for the electrical recording or stimulation of endocardial structures. in particular the catheter is used for obtaining and recording electrograms from the atrial region of the heart.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

exactech australia pty ltd - 60512 - shoulder humeral body prosthesis - the equinoxe fixed angle replicator plate kit connects the humeral head to the stem and is used to position the humeral head. the fixed angle replicator plate is used when surgeons prefer not to adjust neck angle and humeral head retroversion. the fixed angle replicator plate kit is a sterile package with one fixed angle replicator plate (made of titanium alloy), one torque defining screw, and one driver. the equinoxe fixed angle replicator plate kit is intended to connect the humeral head to the stem and to position the replacement humeral head as part of a shoulder joint replacement. the device is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 32832 - uncoated knee tibia prosthesis, metallic - the smiles fixed hinge assembly is a co-cr-mo tibial component. stem lengths 140 and 180mm and are available in small and standard sizes. an uhmwpe bumper available in both sizes provides a secondary bearing surface and a soft hyperextension stop, is pre-assembled within the tibial component. the tibial fixed hinge assembly is a component of the mets smiles total knee replacement which is intended for the replacement of diseased or deficient bone around the knee joint. indications: ? painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis ? correction of varus, valgus or post traumatic deformity ? correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement ? ligament deficiencies ? tumor resections ? revision of previously failed total joint arthroplasty ? trauma ? the fixed hinge tibial component is intended for limb salvage procedures requiring radical resection of bone and soft tissue.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 48066 - knee stem - the integral tibial shaft & stem, fixed hinge, coated is a 15mm long titanium shaft, diameter 33mm, with integral hydroxyapatite collar and stem components for the fixed hinged proximal tibial replacement. holding the proximal tibial component with the bore pointing upwards, insert the integral shaft/stem construct ensuring that the alignment lug is correctly engaged. apply multiple sharp blows using the soft ended hammer provided to lock the taper securely in place. for cemented use only. the integral tibial shaft & stem, fixed hinge, coated is a component of the mets proximal tibial modular system which is designed as a modular system that can be used to replace diseased or deficient bone in the proximal tibia. the indications for this modular massive endoprosthetic system are: ? primary bone tumours ? secondary tumours arising in bone ? non-neoplastic conditions affecting the shafts of long bones ? failed joint replacements ? failed massive replacements

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 34198 - coated knee tibia prosthesis - the proximal tibial fixed hinge with reattachment and bumper,coated is cocrmo proximal tibial component, with an uhmwpe bumper. in small and standard sizes with ha coated patella tendon reattachment mechanism. the fixed hinge is chosen for cases with significant loss of soft tissue function and where additional constraint is required. an uhmwpe bumper providing a secondary bearing surface and a soft hyperextension stop is pre-assembled with the proximal tibial component. the proximal tibial fixed hinge with reattachment and bumper, coated is a components mets proximal tibial modular system which is designed as a modular system that can be used to replace diseased or deficient bone in the proximal tibia. the indications for this modular massive endoprosthetic system are: ? primary bone tumours ? secondary tumours arising in bone ? non-neoplastic conditions affecting the shafts of long bones ? failed joint replacements ? failed massive replacements

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 32832 - uncoated knee tibia prosthesis, metallic - the proximal tibia fixed hinge, plain is an uncoated cocrmo proximal tibial component with an uhmwpe bumper which provides a secondary bearing surface and a soft hyperextension stop.it is chosen for cases with significant loss of soft tissue function and where additional constraint is required. the assembly sequence should be tibial component onto the shaft stem/stem construct followed by the collar if using the 30mm integral construct. the tibial assembly is then inserted into the tibia. the proximal tibia fixed hinge, plain is a component of the mets proximal tibial modular system which is designed as a modular system that can be used to replace diseased or deficient bone in the proximal tibia. the indications for this modular massive endoprosthetic system are: ? primary bone tumours ? secondary tumours arising in bone ? non-neoplastic conditions affecting the shafts of long bones ? failed joint replacements ? failed massive replacements"

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 48066 - knee stem - integral tibial shaft & stem, fixed hinge titanium shaft with integral stem for the fixed hinged proximal tibial replacement. the 30mm integral shafts/stem is for very small resections < 75mm. the device is 30mm long, has a 120mm straight tibial stem with a diameter of 12>9mm.the 30mm integral shaft/stem construct allows the option to use any of the hydroxyapatite coated collars. for cemented use only. the proximal tibial modular system, integral tibial shaft & stem, fixed hinge (for use with tibial collar) is a component of the mets proximal tibial modular system which is designed as a modular system that can be used to replace diseased or deficient bone in the proximal tibia. the indications for this modular massive endoprosthetic system are: ? primary bone tumours ? secondary tumours arising in bone ? non-neoplastic conditions affecting the shafts of long bones ? failed joint replacements ? failed massive replacements"