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Accessory to the Genesis™ processor for automated label printing on a specimen tube.
Hologic, Inc.
APTIMA TUBE PRINTER, THINPREP GENESIS
In Commercial Distribution
- 15420045514157 ()
ASY-11355
- Microscope slide maker IVD
a multi use ASM001399 for fixing the skull position during neuro FUS clinical treatment
INSIGHTEC LTD
Neuro Stereotactic Frame
In Commercial Distribution
- 07290015461290 ()
ASM001399
- Therapeutic oncological/gynaecological ultrasound system
Examination electrodes, used when performing measurements with the Nevisense on patients. Each electrode can be used up to 20 times for a single patient on several lesions in a single procedure.
Scibase AB
131-0007
In Commercial Distribution
- 07350094440200 ()
131-0007
- Neoplasm electrical impedance spectrometer electrode array
SIR-Y001 (3Gbq/5ml): SIR-Spheres Y90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 3 GBq of Y90 ± 10% (at the time of calibration) in a total of 5 cc water for injection.
Yttrium-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. This is a brachytherapy product considered to be a sealed source device. The yttrium-90 has a purity specification of 999,900 ppm at reference, at (or after) time of manufacture of SIR-Spheres microspheres. The half-life is 64.1 hours. In use requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days leaving only background radiation with no therapeutic value.
SIR-Spheres microspheres themselves are a permanent implant. Each device is for single patient use.
SIRTEX MEDICAL PTY LTD
SIR-Y001
Not in Commercial Distribution
- M425SIRY0010 ()
- Total Volume: 5 Milliliter
- Manual brachytherapy source, permanent implant
SIR-Y002 (1.8Gbq/3ml): SIR-Spheres Y-90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 1.8 GBq of Y90 ± 10% (at the time of calibration) in a total of 3 cc water for injection.
Yttrium-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. This is a brachytherapy product considered to be a sealed source device. The yttrium-90 has a purity specification of 999,900 ppm at reference, at (or after) time of manufacture of SIR-Spheres microspheres. The half-life is 64.1 hours. In use requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days leaving only background radiation with no therapeutic value.
SIR-Spheres microspheres themselves are a permanent implant. Each device is for single patient use.
SIRTEX MEDICAL PTY LTD
SIR-Y002
In Commercial Distribution
- 00850014612146 ()
- Total Volume: 3 Milliliter
- Manual brachytherapy source, permanent implant
SIR-Y001 (3Gbq/5ml): SIR-Spheres Y-90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 3 GBq of Y90 ± 10% (at the time of calibration) in a total of 5 cc water for injection.
Yttrium-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. This is a brachytherapy product considered to be a sealed source device. The yttrium-90 has a purity specification of 999,900 ppm at reference, at (or after) time of manufacture of SIR-Spheres microspheres. The half-life is 64.1 hours. In use requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days leaving only background radiation with no therapeutic value.
SIR-Spheres microspheres themselves are a permanent implant. Each device is for single patient use.
SIRTEX MEDICAL PTY LTD
SIR-Y001
- Manual brachytherapy source, permanent implant
The Patient Therapy Controller (PTC) is a handheld touchscreen device, which allows a patient to initiate a pre-configured supplemental bolus of medication from their implanted Programmable Pump. The patient requests a bolus by pressing the Rx button on the PTC and then placing it over their implanted pump. The Patient Therapy Controller communicates with the implanted pump initiating the supplemental bolus delivery. The settings for the bolus delivery are programmed into the Patient Therapy Controller by a healthcare certified professional (HCP) using the Configuration Device.
Flowonix Medical, Inc.
12860
In Commercial Distribution
- 00810335020174 ()
- Infusion pump programmer
Eversense E3 Sensor Kit contains one Eversense E3 Pouch containing a Sensor in Sensor holder.
SENSEONICS, INCORPORATED
FG-7202-00-301
In Commercial Distribution
- 00817491022974 ()
FG-7202-00-301
- Implantable glucose monitoring system sensor
Eversense E3 Sensor Kit contains one Eversense E3 Pouch containing a Sensor in Sensor holder.
SENSEONICS, INCORPORATED
FG-7201-00-301
In Commercial Distribution
- 00817491022967 ()
FG-7201-00-301
- Implantable glucose monitoring system sensor
Eversense E3 Sensor Kit contains one Eversense E3 Pouch containing a Sensor in Sensor holder.
SENSEONICS, INCORPORATED
FG-7200-00-301
In Commercial Distribution
- 00817491022950 ()
FG-7200-00-301
- Implantable glucose monitoring system sensor