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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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SIR-Spheres® Microspheres Activity Calculator (SMAC) - 00850014612108

Dose activity calculator for Selective Internal Radiation Therapy (SIRT)
SIRTEX MEDICAL PTY LTD
X-SMAC-01
In Commercial Distribution

  • 00850014612108 ()


  • Clinical management support software

SIR-Spheres Accessories Pack - 00850014612092

Accessories Kit (consists of 1 delivery set, 1 v-vial and 1 v-vial holder)
SIRTEX MEDICAL PTY LTD
SIR-K002
In Commercial Distribution

  • 00850014612092 ()


  • General-purpose brachytherapy system applicator, manual

SIR-Spheres Syringe Shield - 00850014612085

SIR-Spheres Syringe Shield
SIRTEX MEDICAL PTY LTD
SIR-S001
In Commercial Distribution

  • 00850014612085 ()


  • Syringe radiation shield

SIR-Spheres V-Vial Holder - 00850014612078

SIR-Spheres V-Vial Holder
SIRTEX MEDICAL PTY LTD
SIR-H001
In Commercial Distribution

  • 00850014612078 ()


  • Vial radiation shield

SIR-Spheres V-Vial - 00850014612061

SIR-Spheres V-Vial
SIRTEX MEDICAL PTY LTD
SIR-V001
In Commercial Distribution

  • 00850014612061 ()


  • General-purpose brachytherapy system applicator, manual

SIR-Spheres Delivery Set - 00850014612054

Sir-Spheres delivery set
SIRTEX MEDICAL PTY LTD
SIR-D001
In Commercial Distribution

  • 00850014612054 ()


  • General-purpose brachytherapy system applicator, manual

SIR-Spheres Delivery Apparatus - 00850014612047

Delivery Apparatus for the administration of SIR-Spheres
SIRTEX MEDICAL PTY LTD
SIR-B001
In Commercial Distribution

  • 00850014612047 ()


  • Radiation shielding container, general-purpose

SIR-Spheres Y-90 resin microspheres - 00850014612030

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
In Commercial Distribution


  • Total Volume: 5 Milliliter


  • Manual brachytherapy source, permanent implant

SIROS Delivery Set - 00850014612023

Sterile disposable tubing designed to provide proper routing of SIR-Spheres
SIRTEX MEDICAL PTY LTD
SIR-10300
In Commercial Distribution

  • 00850014612023 ()
SIR-10300

  • General-purpose brachytherapy system applicator, manual

SIROS D-Vial Prep Set - 00850014612016

Set for the preparation of SIR-Spheres
SIRTEX MEDICAL PTY LTD
SIR-10200
In Commercial Distribution

  • 00850014612016 ()
SIR-10200

  • General-purpose brachytherapy system applicator, manual
  • Vial radiation shield
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