Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

med-el implant systems australasia pty ltd - 35643 - stimulator, electrical, auditory, cochlea - the opus receives auditory sound via microphone. it then transfers this to digital signal via speech coding and transmits this to the implanted cochlear implant, which directly stimulates the inner cochlear. the opus 2 audio processor is a part of the med-el cochlear implant system which is intended to evoke auditory sensation via electrical stimulation of the auditory pathways for severely to profound hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition; additionally for partially deaf individuals who obtain benefit from acoustic amplification in the lower frequencies only, and also for individuals with single sided deafness which is defined as severe to profound hearing impairment in one ear and normal hearing or mild to moderate impairment in the other ear. the audio processor is intended to pick up signals from the environment and convert them for transmission to the implant via the coil.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

med-el implant systems australasia pty ltd - 44067 - surgical procedure kit, ent, reusable - the surgical kit consists of a set of reusable surgical instruments and burrs which can be used by the ent surgeons during med-el ci surgery. the tools facilitate the planning and assessment of the ci surgery and the handling of the med-el ci devices.

Új-Zéland - angol - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - recombinant cholera toxin b subunit 1mg; vibrio cholerae inaba 48 classical biotype 31250 million organisms (heat inactivated); vibrio cholerae inaba 6973 el tor biotype 31250 million organisms (formalin inactivated); vibrio cholerae ogawa 50 classical biotype 62500 million organisms (equal parts heat inactivated and formalin inactivated) - oral suspension - active: recombinant cholera toxin b subunit 1mg vibrio cholerae inaba 48 classical biotype 31250 million organisms (heat inactivated) vibrio cholerae inaba 6973 el tor biotype 31250 million organisms (formalin inactivated) vibrio cholerae ogawa 50 classical biotype 62500 million organisms (equal parts heat inactivated and formalin inactivated) excipient: dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate sodium chloride water for injection citric acid raspberry flavour 52383 ap0551 saccharin sodium sodium bicarbonate sodium carbonate sodium citrate dihydrate citric acid raspberry flavour 52383 ap0551 saccharin sodium sodium bicarbonate sodium carbonate sodium citrate - active immunisation of adults and children from two years of age, who will be visiting areas with an ongoing or anticipated epidemic or who will be spending an extended period of time in areas in which cholera infection is a risk. the vaccine should be considered for foreign aid workers and others intending to visit or spend an extended period of time in areas endemic or epidemic for cholera.

Szingapúr - angol - HSA (Health Sciences Authority)

aenon pharmaceuticals sea pte. ltd. - recombinant cholera toxin b subunit (rctb); vibrio cholerae o1 inaba classic strain (heat inactivated); vibrio cholerae o1 inaba el tor strain (formalin inactivated); vibrio cholerae o1 ogawa classic strain (formalin inactivated); vibrio cholerae o1 ogawa classic strain (heat inactivated) - suspension - 1 mg/dose - recombinant cholera toxin b subunit (rctb) 1 mg/dose; vibrio cholerae o1 inaba classic strain (heat inactivated) 31.25 x 10^9 bacteria; vibrio cholerae o1 inaba el tor strain (formalin inactivated) 31.25 x 10^9 bacteria; vibrio cholerae o1 ogawa classic strain (formalin inactivated) 31.25 x 10^9 bacteria; vibrio cholerae o1 ogawa classic strain (heat inactivated) 31.25 x 10^9 bacteria

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd -

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

med-el implant systems australasia pty ltd - 35643 - stimulator, electrical, auditory, cochlea - the battery powered bte processor is the external component of the ci system supporting electrical & acoustic stimulation (amplification) intended for patients with some functional low frequency hearing. it consists of control unit with the earhook attached, battery pack, coil & coil cable. the coil connects the processor with the implant. the integrated telecoil picks up magnetic sound signals from telephone receivers or loop systems in some public buildings converting them into audible signals the sonnet audio processor is an external part of the med-el cochlear implant system. the med-el cochlear implant system is intended to evoke auditory sensation via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. additionally, the med-el cochlear implant system used in combination with the flex24 or flex20 electrode is intended to evoke auditory sensations via electrical stimulation or via combined electric-acoustic stimulation (eas) of the auditory pathways for partially deaf individuals, who obtain benefit from acoustic amplification in the lower frequencies only. the med-el cochlear implant system is also intended to evoke auditory sensations via electrical stimulation of the auditory pathways for individuals with single?sided deafness, which is defined as severe to profound hearing impairment in one ear and normal hearing or mild to moderate hearing impairment in the other ear.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

med-el implant systems australasia pty ltd - 35643 - stimulator, electrical, auditory, cochlea - an external component of the cochlear implant system which supports electrical stimulation only. powered by batteries and worn behind the ear, it consists of control unit with the earhook attached, battery pack, coil & coil cable. the coil connects the processor with the implant. the processor has an integrated telephone coil. the telecoil picks up magnetic sound signals coming from telephone receivers or loop systems installed in some public buildings & converts them into audible signals. the sonnet audio processor is an external part of the med-el cochlear implant system. the med-el cochlear implant system is intended to evoke auditory sensation via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. additionally, the med-el cochlear implant system used in combination with the flex24 or flex20 electrode is intended to evoke auditory sensations via electrical stimulation or via combined electric-acoustic stimulation (eas) of the auditory pathways for partially deaf individuals, who obtain benefit from acoustic amplification in the lower frequencies only. the med-el cochlear implant system is also intended to evoke auditory sensations via electrical stimulation of the auditory pathways for individuals with single?sided deafness, which is defined as severe to profound hearing impairment in one ear and normal hearing or mild to moderate hearing impairment in the other ear.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

med-el implant systems australasia pty ltd - 35643 - stimulator, electrical, auditory, cochlea - the mi1200 pin implant is the implantable part of the med-el cochlear implant system and can only be used together with compatible med-el external components. the device consists of a stimulator, a coil with a removable magnet within its center, a reference electrode, an eap reference electrode and an active electrode permanently attached to the stimulator. also included in this system is an implant template that replicates the outline of the corresponding implant. the med-el cochlear implant system is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. additionally the med-el cochlear implant system used in combination with the implant variant synchrony pin +flex24 is intended to evoke auditory sensations via electrical stimulation or via combined electric-acoustic stimulation (eas) of the auditory pathways for partially deaf in

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

med-el implant systems australasia pty ltd - 35643 - stimulator, electrical, auditory, cochlea - the mi1200 implant is the implantable part of the med-el cochlear implant system and can only be used together with compatible med-el external components. the device consists of a stimulator, a coil with a removable magnet within its center, a reference electrode, an eap reference electrode and an active electrode permanently attached to the stimulator. also included in this system is an implant template that replicates the outline of the corresponding implant. the med-el cochlear implant system is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. additionally the med-el cochlear implant system used in combination with the implant variant synchrony +flex24 is intended to evoke auditory sensations via electrical stimulation or via combined electric-acoustic stimulation (eas) of the auditory pathways for partially deaf individual

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

med-el implant systems australasia pty ltd - 58794 - cochlear implant assessment system - the max programming interface (pi) is pc controlled connected through usb cable, therefore its entire functionality is software based. the coil allows connection to the implant for clinical evaluations. the programming cable allows connection to the audio processor during fitting. the external coil, programming cables and usb cable are included with the pi. the max programming interface, its coils and cables are intended to be used as an interface for med-el devices in different clinical applications.