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

corin australia pty ltd - 55834 - press-fit hip femur prosthesis, one-piece - the paragon stem pcha is a cementless (press-fit) monoblock bi-planar femoral component of a joint replacement prosthesis to be used in total hip replacement surgery. the stem is made of titanium alloy, with a hydroxyapatite (ha) and titanium plasma composite coating to facilitate bony ingrowth to enhance fixation. the stem is to be used with a compatible femoral head and acetabular cup component. the stem is provided without a collar, and with or without rsa beads. paragon stem pcha is part of the paragon hip system and is intended for use as the femoral component of a total hip replacement. this femoral hip stem is intended for uncemented fixation and single use implantation. this prosthesis may be used for the following conditions, as appropriate: 1. degenerative osteoarthritis of the hip. 2. inflammatory arthritis of the hip. 3. secondary arthritis of the hip, such as may follow trauma (e.g. fracture of the femoral neck, or fracture and/or dislocation of the hip or acetabulum), or congenital conditions (e.g. developmental dysplasia of the hip). 4. displaced intracapsular femoral neck fractures where there is a high risk of non-union or avascular necrosis and bone collapse. 5. avascular necrosis of the femoral head.

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

corin australia pty ltd - 55834 - press-fit hip femur prosthesis, one-piece - the paragon stem pcha, collared is a cementless (press-fit) monoblock bi-planar femoral component of a joint replacement prosthesis to be used in total hip replacement surgery. the stem is made of titanium alloy, with a hydroxyapatite (ha) and titanium plasma composite coating to facilitate bony ingrowth to enhance fixation. the stem is to be used with a compatible femoral head and acetabular cup component. the stem is provided with a collar. paragon stem pcha, collared is part of the paragon hip system and is intended for use as the femoral component of a total hip replacement. this femoral hip stem is intended for uncemented fixation and single use implantation. this prosthesis may be used for the following conditions, as appropriate: 1. degenerative osteoarthritis of the hip. 2. inflammatory arthritis of the hip. 3. secondary arthritis of the hip, such as may follow trauma (e.g. fracture of the femoral neck, or fracture and/or dislocation of the hip or acetabulum), or congenital conditions (e.g. developmental dysplasia of the hip). 4. displaced intracapsular femoral neck fractures where there is a high risk of non-union or avascular necrosis and bone collapse. 5. avascular necrosis of the femoral head.

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

paragon healthcare pty ltd - 16166 - transcutaneous bilirubinometer - a non-invasive transcutaneous bilirubinometer, which is intended to predict serum bilirubin levels in neonates.

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

paragon healthcare pty ltd - 11440 - electrode, electroencephalograph - a noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (eeg), sleep, or evoked potential recording device]. it typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., eeg electrodes) however it is not a preconfigured eeg cap. this is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

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

paragon healthcare pty ltd - 35747 - audiometer, auditory evoked response - accessories for an electroacoustic device that evaluates the activity of the auditory nervous system in response to an acoustic signal at the ear.

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

paragon healthcare pty ltd - 35747 - audiometer, auditory evoked response - portable, noninvasive device for screening the hearing of infants.

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

paragon healthcare pty ltd - 35239 - light therapy unit, photo - intended for the treatment of neonatal hyperbilirubinemia. portable phototherapy light that delivers a narrow band of high-intensity blue light via light emitting diodes (leds)

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

paragon healthcare pty ltd - 33791 - blanket/pad infant phototherapy unit - intended for the treatment of unconjugated hyperbilirubinemia in premature babies and neonates. provides intensive phototherapy underneath the patient.

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

paragon healthcare pty ltd - 41232 - acoustic earmuffs - indicated for short-term (less than 24 hours) hospital use with neonates in a supervised setting to reduce the sound level reaching the neonate?s ears.

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

paragon healthcare pty ltd - 30881 - protection equipment, light therapy, eyewear - intended to be used as a neonatal eye protector for protection from the bright light of phototherapy.