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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Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with Qid 170 cc
Establishment Labs S.A.
ERSM-170Q
In Commercial Distribution

  • 07445161011916 ()
ERSM-170Q

  • Silicone gel-filled breast implant, smooth-surface
Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with Qid 160 cc
Establishment Labs S.A.
ERSM-160Q
In Commercial Distribution

  • 07445161011909 ()
ERSM-160Q

  • Silicone gel-filled breast implant, smooth-surface
Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with Qid 150 cc
Establishment Labs S.A.
ERSM-150Q
In Commercial Distribution

  • 07445161011893 ()
ERSM-150Q

  • Silicone gel-filled breast implant, smooth-surface
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
In Commercial Distribution


  • Total Volume: 5 Milliliter


  • Manual brachytherapy source, permanent implant
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
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