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

  • 08800011120009 ()


  • Stationary basic diagnostic x-ray system, analogue
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 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
Source Loading Adapter
Nucletron B.V.
080287P01-00
In Commercial Distribution

  • 08717213006836 ()
  • 08717213041455 ()


  • Brachytherapy system remote-afterloading operator console
No Description
Advanced Bionics, LLC
AB-6500
In Commercial Distribution



  • Hearing implant implantable-component tester, postoperative
No Description
Advanced Bionics, LLC
CI-6101
In Commercial Distribution



  • Hearing implant implantable-component tester, postoperative
Digital Imaging Software
DRGEM Corporation
RADMAX
In Commercial Distribution

  • 08800011170004 ()


  • Basic diagnostic x-ray system application software
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
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-EC40S
In Commercial Distribution

  • 08800011121907 ()


  • Stationary basic diagnostic x-ray system, analogue
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-EC32S
In Commercial Distribution

  • 08800011121891 ()


  • Stationary basic diagnostic x-ray system, analogue
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