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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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PaX-i3D Green - 08800016400090

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / Xmaru1524CF(V) / 1210SGA)
VATECH CO., LTD.
PHT-60CFO
Not in Commercial Distribution

  • 08800016400090 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Green - 08800016400076

Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1501CF / Xmaru1524CF(V))
VATECH CO., LTD.
PHT-60CFO
Not in Commercial Distribution

  • 08800016400076 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Green - 08800016400052

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / Xmaru1215CF / 1210SGA)
VATECH CO., LTD.
PHT-60CFO
In Commercial Distribution

  • 08800016400052 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Green - 08800016400045

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition (Xmaru1501CF / Xmaru1215CF / Xmaru2301CF)
VATECH CO., LTD.
PHT-60CFO
In Commercial Distribution

  • 08800016400045 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Green - 08800016400038

Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1501CF / Xmaru1215CF)
VATECH CO., LTD.
PHT-60CFO
In Commercial Distribution

  • 08800016400038 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Smart - 08800016400021

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type) Image Acquisition (Xmaru1404CF / 1210SGA)
VATECH CO., LTD.
PHT-30LFO
Not in Commercial Distribution

  • 08800016400021 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Smart - 08800016400014

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition (Xmaru1404CF / Xmaru2301CF)
VATECH CO., LTD.
PHT-30LFO
In Commercial Distribution

  • 08800016400014 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Smart - 08800016400007

Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1404CF)
VATECH CO., LTD.
PHT-30LFO
In Commercial Distribution

  • 08800016400007 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

IOPI® - 10810091040239

The IOPI® Pro (Model 3.1) is used by healthcare professionals to measure, evaluate, and increase the strength and endurance of the tongue and lip in patients with oral motor disorders, including dysphagia, dysarthria, and obstructive sleep apnea. The IOPI® Pro is intended for clinical use by healthcare professionals.
Iopi Medical LLC
Model 3.1
In Commercial Distribution

  • 10810091040253 ()
  • 10810091040239 ()
  • 10810091040321 ()
  • 10810091040260 ()
  • 10810091040420 ()
8-3101

  • Dynamometer force gauge

IOPI® - 10810091040048

The IOPI® Trainer (Model 3.2) is used to increase the strength and endurance of the tongue and lip in patients with oral motor disorders, including dysphagia, dysarthria, and obstructive sleep apnea. The IOPI® Trainer is intended for clinical use and use by patients outside their therapy sessions under the direction of a healthcare professional.
Iopi Medical LLC
Model 3.2
In Commercial Distribution

  • 10810091040024 ()
  • 10810091040048 ()
  • 10810091040178 ()
8-3201

  • Dynamometer force gauge
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