אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

avant-garde surgical pty ltd - 56642 - orthopaedic bone screw, non-biodegradable, non-sterile - the general indications of the osteosynthesis screws are: - treatment, reduction and stabilization of fractures for the recovery of functionality. - osteotomy. - reconstructions

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

ascend surgical and medical - 47890 - disposable battery-powered surgical/orthopaedic lavage system - to be used for the irrigation and suction of a surgical site in the field of hip and knee arthroplasty. it is intended to remove loose tissue, bone meal and, especially during revision surgery in prosthetics, bone cement remnants from the surgical site. it can be used to flush through the different deep cavities.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

personalised surgery pty ltd - 44052 - surgical procedure kit, orthopaedic, single-use, non-medicated - a collection of various surgical instruments and materials required to perform an orthopaedic procedure.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

personalised surgery pty ltd - 44054 - surgical procedure kit, orthopaedic, reusable - a collection of various surgical instruments, and the necessary materials to perform an orthopaedic surgical procedure. this device can be presented as a kit, tray or set. it is reusable after the appropriate cleaning/sterilizing of the instruments/reusable products.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

dksh australia pty ltd - ct756 - varicella zoster virus (human herpesvirus 3) ivds - ct756 varicella zoster virus (human herpesvirus 3) ivds immunserological in vitro diagnostic medical devices to be used in infectious disease diagnostics.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

endotherapeutics pty ltd - 58841 - endoscope cap - the otsg xcavator is an instrument for flexible endoscopy intended for the grasping of large volumes of tissue and foreign bodies in the gastrointestinal tract.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

mathys orthopaedics pty ltd - 32390 - drill bit, surgical - drill bit with quick coupling designed for use in orthopaedic surgery.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

mathys orthopaedics pty ltd - 33968 - screwdriver, surgical - a reusable surgical screwdriver designed to fit into a screw head in order to apply torque to tighten the screw or to remove the screw.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

miltenyi biotec australia pty limited - 63858 - blood donor bag tube divider/sealer - this application is for the artg inclusion of the macs tubesealer (p/n 44364). as an accessory of the clinimacs prodigy, the macs tubesealer is intended to seal pvc and eva tubes of clinimacs prodigy tubing sets (artg identifier: 174902) installed on the clinimacs prodigy (artg identifier 151102). the macs tubesealer must only be used in combination with the clinimacs prodigy. the macs tubesealer is comprised of a hand unit with cable and connector. the hand unit is connected to the clinimacs prodigy by a cable. the hand unit consists of an rf-generator with sense control, an ergonomic handgrip with trigger, a mobile electrode that can be removed for cleaning, and a cable with a connector. after the sealing procedure, the tube is easily pulled apart due to the distinct sealing pattern. the sealer is powered by the clinimacs prodigy with 30.5 v. the sealing procedure is initiated by an operator by placing the tube in the tubing slot and pressing the trigger. the seal indicator led indicates the progress of the sealing procedure

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

miltenyi biotec australia pty limited - 58868 - extracorporeal circuit waste bag, non-sterile - this application is for the inclusion of the clinimacs prodigy supplementary bag (200-076-612). the clinimacs prodigy supplementary bag is an accessory to the clinimacs prodigy system (see artg database for respective components), which is intended for the in-vitro separation of specific human cells that is based on the magnetic cell separation technology (macs? technology) developed by miltenyi biotec b.v. & co. kg. the clinimacs prodigy supplementary bag is intended to reduce the risk of contact to infectious sample material in case of a leakage. the clinimacs prodigy supplementary bag must only be used in combination with the clinimacs prodigy. the clinimacs prodigy supplementary bag does not claim any medical benefit and has no medical purpose on its own. the clinimacs prodigy supplementary bag is a pre-installed disposable bag placed within the compartment underneath the clinimacs prodigy. fluids accidentally leaking out of the chamber due to a malfunction are collected in the clinimacs prodigy supplementary bag. the removable supplementary bag can be disposed according to the instructions given in the user manual. after a leakage event the clinimacs prodigy must be cleaned and disinfected according to the instructions given in the clinimacs prodigy user manual. the clinimacs prodigy supplementary bag is to be replaced by a new bag.