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EXD-001 Kit
Avertix Medical Inc.
0203-2100-002#P16
In Commercial Distribution
- 00850012625025 ()
0203-2100-002#P16
- Implantable cardiac monitor programmer/transmitter/alarm
Hex Torque Wrench (Separate, in Sterile Pack)
Avertix Medical Inc.
2100-001
In Commercial Distribution
- 00850012625018 ()
- 10850012625015 ()
2100-001
- Surgical torque wrench, single-use
IMD AMSG3-E Kit
Avertix Medical Inc.
0212-2100-001#P16
In Commercial Distribution
- 00850012625001 ()
0212-2100-001#P16
- Implantable cardiac monitor
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
PD-L1 IHC 28-8 pharmDx
AGILENT TECHNOLOGIES, INC.
SK005
In Commercial Distribution
- 05700571108161 ()
- 50 test
- Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry
PD-L1 IHC 22C3 pharmDx
AGILENT TECHNOLOGIES, INC.
SK006
In Commercial Distribution
- 05700571107300 ()
- 50 test
- Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry
c-Kit pharmDx for Autostainer
AGILENT TECHNOLOGIES, INC.
K1907
Not in Commercial Distribution
- 05700571104057 ()
- 35 Tests
- CD117 (c-kit) cell marker IVD, kit, enzyme immunohistochemistry
c-Kit pharmDx
AGILENT TECHNOLOGIES, INC.
K1906
Not in Commercial Distribution
- 05700571104040 ()
- 25 Tests
- CD117 (c-kit) cell marker IVD, kit, enzyme immunohistochemistry
EGFR pharmDx for Autostainer
AGILENT TECHNOLOGIES, INC.
K1494
Not in Commercial Distribution
- 05700571103982 ()
- 50 Tests
- Epidermal growth factor receptor (EGFR) IVD, kit, enzyme immunohistochemistry