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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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System for non-invasive tumor ablation within head through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS) for Siemens MRI scanners.
INSIGHTEC LTD
SYS0004000-BA 4000 Type 1.1
In Commercial Distribution

  • 07290015461092 ()

  • Weight: 1700 Kilogram
EXABLATE 4000 Type 1.1

  • Therapeutic oncological/gynaecological ultrasound system
System for non-invasive tumor ablation within head through Focal Ultrasound (FUS) treatment under Magnetiv Resonance (MR) guidance (i.e. MRgFUS).
INSIGHTEC LTD
4000 Type 1.0
In Commercial Distribution

  • 07290015461023 ()

  • Weight: 1350 Kilogram
EXABLATE 4000 Type 1.0

  • Therapeutic oncological/gynaecological ultrasound system
System for non-invasive tumor ablation through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS). Customer replaceable patient cradle.
INSIGHTEC LTD
2100 Type 1.0/1.1/1.11
In Commercial Distribution

  • 07290015461016 ()

  • Weight: 890 Kilogram
EXABLATE 2100

  • Therapeutic oncological/gynaecological ultrasound system
System for non-invasive tumor ablation through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS).
INSIGHTEC LTD
2000
In Commercial Distribution

  • 07290015461009 ()

  • Weight: 890 Kilogram
EXABLATE 2000

  • Therapeutic oncological/gynaecological ultrasound system
Audio Processor Battery Pack Cover
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
30837
In Commercial Distribution

  • 09008737308377 ()


  • Cochlear implant/auditory brainstem implant battery
Audio Processor Battery Pack Cover
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
30836
In Commercial Distribution

  • 09008737308360 ()


  • Cochlear implant/auditory brainstem implant battery
Audio Processor Battery Pack Cover
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
30835
In Commercial Distribution

  • 09008737308353 ()


  • Cochlear implant/auditory brainstem implant battery
Audio Processor Battery Pack Cover
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
30834
In Commercial Distribution

  • 09008737308346 ()


  • Cochlear implant/auditory brainstem implant battery
Audio Processor Battery Pack Cover
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
30833
In Commercial Distribution

  • 09008737308339 ()


  • Cochlear implant/auditory brainstem implant battery
Audio Processor
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
30753
Not in Commercial Distribution

  • 09008737307530 ()


  • Cochlear implant/auditory brainstem implant sound processor
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