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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
SPINEGUARD
DSG Ratcheting Handle A
In Commercial Distribution

  • 03662674000235 ()
D1RH0001

  • Manual surgical rotary handpiece, reusable
No Description
SPINEGUARD
DSG Threaded Shaft C - Ø5.5mm
In Commercial Distribution

  • 03662674000228 ()
D1TA0003

  • Manual surgical rotary handpiece, reusable
No Description
SPINEGUARD
DSG Threaded Shaft B - Ø5.5mm
In Commercial Distribution

  • 03662674000211 ()
D1TA0002

  • Manual surgical rotary handpiece, reusable
No Description
SPINEGUARD
DSG Threaded Shaft A - Ø5.5mm
In Commercial Distribution

  • 03662674000204 ()
D1TA0001

  • Manual surgical rotary handpiece, reusable
No Description
ELECTRONIQUE DU MAZET
2.0
In Commercial Distribution

  • 03701330200005 ()


  • Hair extraction punch
No Description
BODYCAP
P030-M
In Commercial Distribution

  • 03665810000045 ()


  • Continuous electronic patient thermometer, battery-powered
No Description
BODYCAP
P040-M_FCC
In Commercial Distribution

  • 03665810000038 ()


  • 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
ProMap Lite is designed to display medical images of different modalities, prepare these images for an ultrasound-guided prostate procedure, and review the images and data generated during an ultrasound-guided prostate procedure.
KOELIS
KSOF-2602
In Commercial Distribution

  • 03665134000714 ()


  • Image segmentation application software
Surface 2D probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, small organs, soft tissues, urology and vascular applications Frequencies: 7-15MHz Field of view 40 mm
KOELIS
K2DLN00
In Commercial Distribution

  • 03665134000530 ()
  • 03665134000103 ()


  • General-purpose ultrasound imaging system
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