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

integra neurosciences pty ltd - 33586 - single-patient physiologic monitoring system - the integra licox pto2 and temperature monitor measures oxygen partial pressure (pto2) and temperature in brain tissue and these paramters are used as an aid in determination of the perfusion status of brain tissue.

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

integra neurosciences pty ltd - 46807 - head-worn light, battery-powered - the integra duo led surgical headlight system is designed to provide supplemental illumination aiding visualization during surgical, diagnostic, or therapeutic procedures.

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

integra neurosciences pty ltd - 46170 - skin regeneration template, human-/animal-derived - a bilayer membrane system for skin replacement. the dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. the epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound. it is indicated for the post excisional treatment of full-thickness and partial-thickness injuries where sufficient auto graft is not available at the time of excision or not desirable due to the physiological condition of the patient. integra dermal regeneration template is also indicated for use in reconstruction of post excisional, full-thickness defects of the integument where there is, in the opinion of the treating surgeon, a potential benefit to the patient by improving the reconstructive outcome or decreasing their mortality/morbidity.

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

integra neurosciences pty ltd - 46170 - skin regeneration template, human-/animal-derived - a porous matrix of fibers of cross-linked bovine tendon collagen and a glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. indicated to add extra thickness where required (to the integra bi-layer dermal replacement) for the postexcisional treatment of full thickness and partial-thickness injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient. it is also indicated for use in reconstruction of postexcisional, full-thickness defects of the integument where there is, in the opinion of the treating surgeon, a potential benefit to the patient by improving the reconstructive outcome or decreasing their mortality/morbidity.

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

integra neurosciences pty ltd - 46170 - skin regeneration template, human-/animal-derived - a bilayer membrane system for skin replacement. the dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. the epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound. it is indicated for the post excisional treatment of full-thickness and partial-thickness injuries where sufficient auto graft is not available at the time of excision or not desirable due to the physiological condition of the patient. integra dermal regeneration template is also indicated for use in reconstruction of post excisional, full-thickness defects of the integument where there is, in the opinion of the treating surgeon, a potential benefit to the patient by improving the reconstructive outcome or decreasing their mortality/morbidity.

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

integra neurosciences pty ltd - 62772 - neurosurgical retraction system, brain - the integra brain retractor system is indicated to construct a framework surrounding the operative site for the purposes of retracting tissue during neurosurgical procedures, and also serves to support and position various instruments and handrests.

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

integra neurosciences pty ltd - 15974 - reservoir, cerebrospinal fluid - the reservoir is designed for subcutaneous placement and attaches to a ventricular catheter at the a connector. the reservoir is made with a suture flange at its base for attachment to the periosteum. the reservoir incorporates a plugged distal outlet tube in addition to a bottom inlet tube.the plugged outlet tube may be unplugged and connected to a distal catheter allowing the reservoir to be used in a shunting system , if the latter is indicated . the integra csf reservoir provides access to the lateral cerebral ventricles via hypodermic puncture. it is useful in obtaining csf samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. the reservoir provides easy access to the lateral ventricles and to cystic tumors for the injection of chemotherapeutic agents and/or radio-isotopes. the convertible integra csf reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt csf from the lateral ventricles into either th

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

integra neurosciences pty ltd - 15974 - reservoir, cerebrospinal fluid - the reservoir is designed for subcutaneous placement and attaches to a separately supplied ventricular catheter at the straight connector. the reservoir is made with a suture flange at its base for attachment to the periosteum. access is obtained by penetrating the reservoir with a needle.in this manner, cerebrospinal fluid may be withdrawn or other fluid injected into the reservoir. the integra mini reservoirs provide access to the lateral cerebral ventricles via hypodermic puncture. it is useful in obtaining csf samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. the reservoir provides easy access to the lateral ventricles and to cystic tumors for the injection of chemotherapeutic agents and or radio-isotopes.

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

integra neurosciences pty ltd - 15974 - reservoir, cerebrospinal fluid - the reservoir is designed for subcutaneous placement and attaches to a ventricular catheter. the reservoir is made with a suture flange at its base for attachment to the periosteum. the reservoir has an inlet tubing entering from the side of the reservoir rather than from the base. this design eliminates the need for a formal burr hole,provides greater latitude in positioning and allows the ventricular catheter to be revised without disturbing the reservoir. the integra csf reservoir provides access to the lateral cerebral ventricles via hypodermic puncture. it is useful in obtaining csf samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. the reservoir provides easy access to the lateral ventricles and to cystic tumors for he injection of chemotherapeutic agents and/or radio-isotopes

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

integra neurosciences pty ltd - 15974 - reservoir, cerebrospinal fluid - the reservoir is designed for subcutaneous placement and attaches to the ventricular catheter at the straight connector. the reservoir is made with a suture flange at its base for attachment to the periosteum. access is obtained by penetrating the reservoir dome with a 25-gauge or smaller needle. in this manner, cerebrospinal fluid may be withdrawn or other fluid injected into the reservoir. a ventricular catheter is supplied with the larger standard but not the mini reservoir. the integra csf reservoir provides access to the lateral cerebral ventricles via hypodermic puncture. it is useful in obtaining csf samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. the reservoir provides easy access to the lateral ventricles and to cystic tumors for the injection of chemotherapeutic agents and/or radio-isotopes.