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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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The Image-Guided Implantation system is an image-guided surgery system, designed to provide guidance of surgical instruments used in dental implantation procedures. The system implements the well-established advances in the fields of computer-aided surgery and image-guided surgery into the field of dental implantology. The IGI-system provides accurate guidance of the surgical instruments with regard to the patient’s anatomical structures and to the pre-surgical plan, based on the patient’s CT imaging. The system is an infra-red optics-based navigational system, which utilizes an infra-red camera sensor and light-emitting diodes (LEDs) to monitor objects in a defined space. The system comprises of the following components: computer processing unit, monitor, tracking camera and trackable appliances (designed to monitor the surgical hand-piece and patient position).
IMAGE NAVIGATION LTD
A-IG-0005
In Commercial Distribution

  • 07290016855005 ()
A-IG-0005

  • Dental stereotactic surgery system
Cue Upgrade Kit (Probe, Activator, Mnt arm)
Bard Access Systems, Inc.
9770607
In Commercial Distribution

  • 00801741155406 ()
9770607

  • Extracorporeal ultrasound imaging transducer, hand-held
Site~Rite 8 20mm Cue Linear Probe (Refurbished)
Bard Access Systems, Inc.
9770603R
In Commercial Distribution

  • 00801741155383 ()
9770603R

  • Extracorporeal ultrasound imaging transducer, hand-held
Mistral-Air® Warming Unit
The Surgical Company International B.V.
MA1200-US
In Commercial Distribution

  • 18719867000076 ()


  • Circulating-air whole-body heating system control unit
Mistral-Air® Warming Unit - SYK
The Surgical Company International B.V.
MA1200-PM
In Commercial Distribution

  • 18719867000069 ()


  • Circulating-air whole-body heating system control unit
No Description
Beijing East Whale Imaging Technology Co.,Ltd.
P9
In Commercial Distribution

  • 06970528550056 ()

  • Width: 598 Millimeter
  • Length: 524 Millimeter


  • Ultrasound mobile medical facility
No Description
Beijing East Whale Imaging Technology Co.,Ltd.
P7
In Commercial Distribution

  • 06970528550049 ()

  • Length: 524 Millimeter
  • Width: 598 Millimeter


  • Ultrasound mobile medical facility
No Description
Beijing East Whale Imaging Technology Co.,Ltd.
P5
In Commercial Distribution

  • 06970528550032 ()

  • Width: 598 Millimeter
  • Length: 524 Millimeter


  • Ultrasound mobile medical facility
No Description
Beijing East Whale Imaging Technology Co.,Ltd.
DigiArc 100AU+
In Commercial Distribution

  • 06970528550025 ()

  • Weight: 600 Kilogram
  • Width: 922 Millimeter
  • Length: 2234 Millimeter
  • Height: 2540 Millimeter


  • Mobile general-purpose fluoroscopic x-ray system, digital
No Description
Beijing East Whale Imaging Technology Co.,Ltd.
DigiArc 100AU
In Commercial Distribution

  • 06970528550018 ()

  • Weight: 600 Kilogram
  • Width: 922 Millimeter
  • Length: 2234 Millimeter
  • Height: 2540 Millimeter


  • Mobile general-purpose fluoroscopic x-ray system, digital
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