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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 - 08800011121662

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-E32S
In Commercial Distribution

  • 08800011121662 ()


  • 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

GXR-ES,ECS Diagnostic X-ray System - 08800011121648

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-E20S
In Commercial Distribution

  • 08800011121648 ()


  • Stationary basic diagnostic x-ray system, analogue

FDR Clinica - 08800011121624

100-240V~ / 125kV
DRGEM Corporation
FDR Clinica FGXR-U40S
In Commercial Distribution

  • 08800011121624 ()


  • Stationary basic diagnostic x-ray system, analogue

FDR Clinica - 08800011121600

100-240V~ / 125kV
DRGEM Corporation
FDR Clinica FGXR-U32S
In Commercial Distribution

  • 08800011121600 ()


  • 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 - 08800011121495

110-120V~ / 150kV
DRGEM Corporation
FDR Clinica FGXR-C32S
In Commercial Distribution

  • 08800011121495 ()


  • Stationary basic diagnostic x-ray system, analogue

syngo.Interventional - 04056869026305

syngo.Interventional VB20; Medical Device syngo.Interventional VB20 is covered by NFJ to K143319 Syngo X-Workplace VD10
Siemens Healthcare GmbH
10849169
In Commercial Distribution

  • 04056869026305 ()


  • Basic diagnostic x-ray system application software

syngo Application Software KIT - 04056869025919

syngo Application Software VD1,syngo Application Software KIT,Registered Medical Devices,syngo Application Software GTIN 04056869012902
Siemens Healthcare GmbH
10849112
In Commercial Distribution

  • 04056869025919 ()


  • Basic diagnostic x-ray system application software

syngo Application Software Media - 04056869025902

syngo Application Software VD1;syngo Application Software Media;Registered Medical Devices:syngo Application Software – GTIN 04056869012902
Siemens Healthcare GmbH
10849116
In Commercial Distribution

  • 04056869025902 ()


  • Basic diagnostic x-ray system application software
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