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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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single use RF head coil for MRI imaging during neuro MRI-guided FUS treatment. a part of 1.5T neuro kit for USA (SET000937)
INSIGHTEC LTD
Neuro Head coil
In Commercial Distribution

  • 07290015461184 ()
ASC002258-AA

  • Therapeutic oncological/gynaecological ultrasound system
Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
3DM-SYS-INTL3D-MOB
In Commercial Distribution

  • 15420045510562 ()
3DM-SYS-INTL3D-MOB

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
3DM-SYS-INTL2D-MOB
In Commercial Distribution

  • 15420045510593 ()
3DM-SYS-INTL2D-MOB

  • Stationary mammographic x-ray system, digital
The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression.
PREMIA SPINE LTD
86002
In Commercial Distribution

  • 07290014064089 ()


  • Posterior lumbar spine prosthesis
The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression.
PREMIA SPINE LTD
85860
In Commercial Distribution

  • 07290014064072 ()


  • Posterior lumbar spine prosthesis
The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression.
PREMIA SPINE LTD
82645
In Commercial Distribution

  • 07290014064065 ()


  • Posterior lumbar spine prosthesis
The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression.
PREMIA SPINE LTD
86001
In Commercial Distribution

  • 07290014064058 ()


  • Posterior lumbar spine prosthesis
The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression.
PREMIA SPINE LTD
85859
In Commercial Distribution

  • 07290014064041 ()


  • Posterior lumbar spine prosthesis
The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression.
PREMIA SPINE LTD
82644
In Commercial Distribution

  • 07290014064034 ()


  • Posterior lumbar spine prosthesis
The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression.
PREMIA SPINE LTD
86000
In Commercial Distribution

  • 07290014064027 ()


  • Posterior lumbar spine prosthesis
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