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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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DRGEM - 08800011120016

220-230V~ / 150kV
DRGEM Corporation
GXR-32S
In Commercial Distribution

  • 08800011120016 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120009

220-230V~ / 125kV
DRGEM Corporation
GXR-32S
In Commercial Distribution

  • 08800011120009 ()


  • Stationary basic diagnostic x-ray system, analogue

Will3D - 08800005200298

Will3D is one of the components of a Picture Archiving and Communications System(PACS). Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting.
HDX WILL CORP.
Will3D
In Commercial Distribution

  • 08800005200298 ()


  • General-purpose dental x-ray system application software

WillCeph - 08800005200168

WillCeph is intended for use by orthodontists, oral surgeons, and their clinical staffs in storing and organizing images, including digitla photographs, x-rays, and others. The system includes the capability to trace a cephalometric x-ray, analyze the measurements taken, and make growth or surgical predictions
HDX WILL CORP.
WillCeph
In Commercial Distribution

  • 08800005200168 ()


  • General-purpose dental x-ray system application software

MicroSelectron Digital - 08717213041455

Source Loading Adapter
Nucletron B.V.
080287P01-00
In Commercial Distribution

  • 08717213006836 ()
  • 08717213041455 ()


  • Brachytherapy system remote-afterloading operator console

VisionX - E247E7300A10

VisionX version 3.0.x
DÜRR DENTAL SE
E7300
In Commercial Distribution

  • E247E7300A10 ()


  • General-purpose dental x-ray system application software

VisionX - E247E7300

Dental Imaging Software. Software Version 2.x.x.
DÜRR DENTAL SE
E7300
In Commercial Distribution

  • E247E7300 ()


  • General-purpose dental x-ray system application software

DBSWIN - E247E7200A0

Dental Imaging Software. Software Version 5.x.x.
DÜRR DENTAL SE
E7200A
Not in Commercial Distribution

  • E247E7200A0 ()


  • General-purpose dental x-ray system application software

DBSWIN 5.11.0 - E247E72000

No Description
DÜRR DENTAL SE
E7200
Not in Commercial Distribution

  • E247E72000 ()


  • General-purpose dental x-ray system application software

GXR-ES,ECS Diagnostic X-ray System - 08800011121914

The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device Identifier) is assigned based on the system model name, power specifications, and maximum x-ray tube voltage of the x-ray tube. *Power Specification (V) / maximum tube Voltage (kV) : 100-120 V~ / 125kV
DRGEM Corporation
GXR-EC50S
In Commercial Distribution

  • 08800011121914 ()


  • Stationary basic diagnostic x-ray system, analogue
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