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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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GXR-ES,ECS Diagnostic X-ray System - 08800011121679

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) : 200-240 V~ / 125kV
DRGEM Corporation
GXR-E40S
In Commercial Distribution

  • 08800011121679 ()


  • Stationary basic diagnostic x-ray system, analogue

GXR-ES,ECS Diagnostic X-ray System - 08800011121655

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) : 200-240 V~ / 125kV
DRGEM Corporation
GXR-E25S
In Commercial Distribution

  • 08800011121655 ()


  • Stationary basic diagnostic x-ray system, analogue

FDR Clinica - 08800011121631

100-240V~ / 150kV
DRGEM Corporation
FDR Clinica FGXR-U40S
In Commercial Distribution

  • 08800011121631 ()


  • Stationary basic diagnostic x-ray system, analogue

FDR Clinica - 08800011121617

100-240V~ / 150kV
DRGEM Corporation
FDR Clinica FGXR-U32S
In Commercial Distribution

  • 08800011121617 ()


  • Stationary basic diagnostic x-ray system, analogue

FDR Clinica - 08800011121594

220-230V~ / 150kV
DRGEM Corporation
FDR Clinica FGXR-C52S
In Commercial Distribution

  • 08800011121594 ()


  • Stationary basic diagnostic x-ray system, analogue

FDR Clinica - 08800011121570

110-120V~ / 150kV
DRGEM Corporation
FDR Clinica FGXR-C52S
In Commercial Distribution

  • 08800011121570 ()


  • Stationary basic diagnostic x-ray system, analogue

FDR Clinica - 08800011121556

220-230V~ / 150kV
DRGEM Corporation
FDR Clinica FGXR-C40S
In Commercial Distribution

  • 08800011121556 ()


  • Stationary basic diagnostic x-ray system, analogue

FDR Clinica - 08800011121525

110-120V~ / 125kV
DRGEM Corporation
FDR Clinica FGXR-C40S
In Commercial Distribution

  • 08800011121525 ()


  • Stationary basic diagnostic x-ray system, analogue

FDR Clinica - 08800011121501

220-230V~ / 125kV
DRGEM Corporation
FDR Clinica FGXR-C32S
In Commercial Distribution

  • 08800011121501 ()


  • Stationary basic diagnostic x-ray system, analogue

FDR Clinica - 08800011121488

110-120V~ / 125kV
DRGEM Corporation
FDR Clinica FGXR-C32S
In Commercial Distribution

  • 08800011121488 ()


  • Stationary basic diagnostic x-ray system, analogue
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