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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
GE HEALTHCARE JAPAN CORPORATION
C1-6-D
In Commercial Distribution

  • 00840682112390 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
No Description
PARALLEL DESIGN
M5Sc-D
In Commercial Distribution

  • 00840682111966 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
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
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
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

  • 10810091040000 ()
  • 10810091040031 ()
  • 10810091040017 ()
  • 10810091040154 ()
  • 10810091040161 ()
8-3101

  • Dynamometer force gauge
X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
Rayence Co., Ltd.
1417WCE-GF
In Commercial Distribution

  • 08800018602171 ()


  • Indirect flat panel x-ray detector
X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
Rayence Co., Ltd.
1417WCE-HS
In Commercial Distribution

  • 08800018602164 ()


  • Indirect flat panel x-ray detector
X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
Rayence Co., Ltd.
1417WCE-HR
In Commercial Distribution

  • 08800018602157 ()


  • Indirect flat panel x-ray detector
X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
Rayence Co., Ltd.
1417WCE
In Commercial Distribution

  • 08800018602140 ()


  • Indirect flat panel x-ray detector
The 0909FCB flat panel detector employs a CsI:Tl scintillator for X-ray-to-light converter. Column-structurized CsI:Tl scintillator have high resolution performance due to much less light blurring, and is thus available for a longer period of time. CMOS active pixel detector makes extremely low noise level and highly sensitive performance. Due to seamless one chip CMOS, there is no data missing or artifacts. The high physical and functional performance of 0909FCB gives competitive image quality. The RAW files can be further processed as DICOM compatible image files by separate console SW for a radiographic diagnosis and analysis.
Rayence Co., Ltd.
0909FCB
In Commercial Distribution

  • 08800018600900 ()


  • Indirect flat panel x-ray detector
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