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

compliance management solutions - 38594 - artificial crown, custom-made, all ceramic - the sprig ezcrown is intended to be used as a functional restoration, including for badly decayed deciduous (primary) teeth, until the adult tooth erupts. the sprig ezcrown is indicated for use in infants, children and adolescents (if still have primary teeth)

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

compliance management solutions - 46059 - orthopaedic cement, medicated - rally ab medium viscosity is a sterile, single use, radiopaque bone cement with gentamicin sulphate. it is made of a packet of sterilized powder and a sterile blister pack containing a vial of sterile liquid. rally provides the fixation of a prosthesis to the anatomy/bone and allows for even distribution of weight and stresses between bone and prosthesis. the presence of barium sulphate enables radiopacity. rally medium viscosity (mv) ab is indicated for the fixation of joint prosthesis implants to the host bone. in particular, these cements are indicated where there is the risk or presence of infections caused by organisms susceptible to gentamicin. rally mv ab is intended for use by suitably qualified orthopaedic surgeons, experienced in arthroplasty procedures, in an operating theatre environment.

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

compliance management solutions - 45253 - orthopaedic cement preparation/delivery kit - rally all-in-one systems are sterile, disposable devices for the preparation and application of bone cement pre-dosed with pmma powder with gentamicin. the system contains: - radiopaque pmma bone cement with gentamicin sulphate - cannula for extrusion - pusher-rod to extrude the cement from the cannula - vacuum tube rally mv ab all-in-one system is indicated for the fixation of joint prosthesis implants to the host bone. in particular, these cements are indicated where there is the risk or presence of infections caused by organisms susceptible to gentamicin. rally mv ab all-in-one system is intended for use by suitably qualified orthopaedic surgeons, experienced in arthroplasty procedures, in an operating theatre environment.

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

compliance management solutions - 45253 - orthopaedic cement preparation/delivery kit - rally hv ab all-in-one systems are sterile, disposable devices for the preparation and application of bone cement pre-dosed with pmma powder with gentamicin. the system contains: - radiopaque pmma bone cement with gentamicin sulphate - cannula for extrusion - pusher-rod to extrude the cement from the cannula - vacuum tube rally high viscosity (hv) ab all-in-one system is indicated for the fixation of joint prosthesis implants to the host bone. in particular, these cements are indicated where there is the risk or presence of infections caused by organisms susceptible to gentamicin. rally hv ab all-in-one system is intended for use by suitably qualified orthopaedic surgeons, experienced in arthroplasty procedures, in an operating theatre environment.

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

compliance management solutions - 46059 - orthopaedic cement, medicated - rally high viscosity ab bone cement is a sterile, single use, radiopaque bone cement with gentamicin sulphate. it is made of a packet of sterilized powder and a sterile blister pack containing a vial of sterile liquid. rally provides the fixation of a prosthesis to the anatomy/bone and allows for even distribution of weight and stresses between bone and prosthesis. the presence of barium sulphate enables radiopacity. rally high viscosity (hv) ab bone cement is indicated for the fixation of joint prosthesis implants to the host bone. in particular, these cements are indicated where there is the risk or presence of infections caused by organisms susceptible to gentamicin. rally hv ab bone cement is intended for use by suitably qualified orthopaedic surgeons, experienced in arthroplasty procedures, in an operating theatre environment.

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

compliance management solutions - 38799 - polymer orthopaedic cement restrictor, non-absorbable, sterile - the cement restrictor is intended to be used for plugging the femoral canal during hip arthroplasty surgery. it is indicated for filling the femoral canal during the cement mass in-sertion. it limits the bone cement-bone contact to the proximal part of the femur and allows the application of a pressure on the bone cement before and/or after the stem insertion.

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

compliance management solutions - 40900 - patient positioning device, diagnostic imaging/radiotherapy, extremity - the device is intended to support the lower leg during endovascular procedures of the lower limb.

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

compliance management solutions - 16584 - suture, polydioxanone - a sterile, single use polydioxanone suture with needle. consists of suture, sponge, cannula, hub, protect cap. when the needle containing absorbable threads made of polydioxanone material is stuck into patient's face, the thread is inserted. the inserted thread is absorbed by the body over time. the absorbable, polydioxanone suture with needle is intended to be used for the treatment of cheek laxity and improvement of nasolabial folds and facial soft tissue reconstruction in the asymmetry. indicated for skin rejuvenation and wrinkle improvement.

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

compliance management solutions - 42665 - hybrid/coated pancreatic stent - pancreatic drainage stent is intended for the drainage of a pancreatic pseudocyst or a gallbladder through a transgastric or transduodenal approach.

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

compliance management solutions - 61751 - polymer-metal oesophageal stent, sterile - the esophageal stent is indicated for application in palliative treatment of esophageal malignant and/or benign structures and trachea-esophageal fistula.