Australie - anglais - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 44788 - spinal implant facsimile - a copy of a final spinal implantable device such as spinal cage etc. used to validate the proper size of the permanent device required by the patient and to determine its appropriate position and/or to verify that the site has been cut to the proper dimensions. this trial is reusable.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 44788 - spinal implant facsimile - a re-usable copy of a final spinal prosthesis, graft, or other implantable device used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

sonita medic enterprises pty ltd - 62475 - surgical utensil washer/disinfector test system - washer disinfector cleaning efficacy test kit used as a means to validate the washing/disinfection process performed by a washer/disinfector

Australie - anglais - Department of Health (Therapeutic Goods Administration)

evolution surgical pty ltd - 44788 - spinal implant facsimile - an ancillary instrument which is a copy of a spinal implant used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to proper dimensions.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

amplitude australia pty ltd - 37150 - guide, - device intended to validate the cut surface during total knee replacement navigation.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

abacus dx pty ltd - ct879 - haematology calibrator/control ivds - fetaltrol is an assayed, stabilized 3 level control set designed to validate and monitor the quality of procedures of fetal maternal haemorrhage (fmh) testing. fetaltrol is compatible as a control for both manual (kleihauer bettke methods) and flow cytometry methods

Australie - anglais - Department of Health (Therapeutic Goods Administration)

abacus dx pty ltd - ct1236 - clinical chemistry biological screening ivds - positive and negative controls intended for monitoring post vasectomy sperm counts performed manually to validate the presence or absence of sperm in seminal fluids

Australie - anglais - Department of Health (Therapeutic Goods Administration)

exactech australia pty ltd - 60931 - reverse shoulder head trial prosthesis - the reverse shoulder head trial is a copy of a final reverse shoulder prosthesis head designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. it is hemisphere-shaped (glenosphere) and made of metal and/or polymer. this is a reusable device intended to be sterilized prior to use.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

exactech australia pty ltd - 60937 - reverse shoulder cup trial prosthesis - the reverse shoulder cup trial is a copy of a final reverse shoulder prosthesis cup designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. it connects to a reverse shoulder prosthesis body and articulates with a reverse shoulder prosthesis head and is made of metal and/or polymer. this is a reusable device intended to be sterilized prior to use.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

exactech australia pty ltd - 60935 - humeral body trial prosthesis - the humeral body trial is a copy of a final humeral body prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. it connects to a humeral stem prosthesis and articulates with a standard humeral head prosthesis, or connects to a reverse shoulder prosthesis cup, and is made of metal and/or polymer. this is a reusable device intended to be sterilized prior to use.