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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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No Description
BODYCAP
P030-M
In Commercial Distribution

  • 03665810000045 ()


  • Continuous electronic patient thermometer, battery-powered
A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest on a prostate gland image in anticipation of a fusion with a system compatible with a 3D echography image realized as part of a targeted prostate gland biopsy. Hardware reference: Lenovo Thinkcentre M70a
KOELIS
KURO-4000
In Commercial Distribution

  • 03665134000929 ()


  • Image segmentation application software
Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology application. Frequencies: 4-9 MHz Field of view 72 mm Scanning angle 170°
KOELIS
K3DEL00
In Commercial Distribution

  • 03665134000516 ()
  • 03665134000080 ()


  • General-purpose ultrasound imaging system
Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology and gynecology applications. Frequencies: 4-9 MHz Field of view 146° Scanning angle 90° Radius 10 mm
KOELIS
K3DEC00-2
In Commercial Distribution

  • 03665134000509 ()
  • 03665134000073 ()


  • General-purpose ultrasound imaging system
Dose Calibrator Read Out Unit
Comecer Netherlands B.V.
0203010016
In Commercial Distribution

  • 08719324589024 ()


  • Radioisotope calibration system
Measuring unit for the dose calibrator
Comecer Netherlands B.V.
0202020001
In Commercial Distribution

  • 08719324589000 ()


  • Radioisotope calibration system
No Description
ELECTRONIQUE DU MAZET
2.0
In Commercial Distribution

  • 03701330200005 ()


  • Hair extraction punch
No Description
AD REM TECHNOLOGY
2.1
In Commercial Distribution

  • 03701084900039 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
AD REM TECHNOLOGY
2.1
In Commercial Distribution

  • 03701084900015 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
AD REM TECHNOLOGY
2.1
In Commercial Distribution

  • 03701084900022 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
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