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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-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
The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay intended for confirming the presence of and differentiating antibodies to HTLV-I and HTLV-II in human serum and plasma. It is intended for use as a supplemental (additional, more specific) test for human serum and plasma samples with repeatedly reactive results by an FDA licensed HTLV-I/II donor screening test. The MP Diagnostics HTLV Blot 2.4 is intended for use in a manual mode or a semi-automated mode using the MP Diagnostics AutoBlot System 20. This test is not intended for use in medical diagnosis.
MP BIOMEDICALS ASIA PACIFIC PTE. LTD.
36 test
In Commercial Distribution

  • 08887581000016 ()
07110888036

  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot
The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay intended for confirming the presence of and differentiating antibodies to HTLV-I and HTLV-II in human serum and plasma. It is intended for use as a supplemental (additional, more specific) test for human serum and plasma samples with repeatedly reactive results by an FDA licensed HTLV-I/II donor screening test. The MP Diagnostics HTLV Blot 2.4 is intended for use in a manual mode or a semi-automated mode using the MP Diagnostics AutoBlot System 20. This test is not intended for use in medical diagnosis.
MP BIOMEDICALS ASIA PACIFIC PTE. LTD.
18 test
In Commercial Distribution

  • 08887581000009 ()
0711088018

  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot
Audio Processor
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
36387
In Commercial Distribution

  • 09008737363871 ()


  • Cochlear implant/auditory brainstem implant sound processor
Audio Processor
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
36386
In Commercial Distribution

  • 09008737363864 ()


  • Cochlear implant/auditory brainstem implant sound processor
Audio Processor
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
36385
In Commercial Distribution

  • 09008737363857 ()


  • Cochlear implant/auditory brainstem implant sound processor
Audio Processor
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
36384
In Commercial Distribution

  • 09008737363840 ()


  • Cochlear implant/auditory brainstem implant sound processor
Audio Processor
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
36383
In Commercial Distribution

  • 09008737363833 ()


  • Cochlear implant/auditory brainstem implant sound processor
Audio Processor
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
36382
In Commercial Distribution

  • 09008737363826 ()


  • Cochlear implant/auditory brainstem implant sound processor
Audio Processor
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
35083
In Commercial Distribution

  • 09008737350833 ()


  • Cochlear implant/auditory brainstem implant sound processor
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