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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 - 08800011120313

220-230V~ / 150kV
DRGEM Corporation
GXR-C52S
In Commercial Distribution

  • 08800011120313 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120283

220-230V~ / 150kV
DRGEM Corporation
GXR-C40S
In Commercial Distribution

  • 08800011120283 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120276

220-230V~ / 125kV
DRGEM Corporation
GXR-C40S
In Commercial Distribution

  • 08800011120276 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120269

110-120V~ / 150kV
DRGEM Corporation
GXR-C40S
In Commercial Distribution

  • 08800011120269 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120252

220-230V~ / 150kV
DRGEM Corporation
GXR-C32S
In Commercial Distribution

  • 08800011120252 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120245

220-230V~ / 125kV
DRGEM Corporation
GXR-C32S
In Commercial Distribution

  • 08800011120245 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120238

110-120V~ / 150kV
DRGEM Corporation
GXR-C32S
In Commercial Distribution

  • 08800011120238 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120221

480V3~ / 150kV
DRGEM Corporation
GXR-82S
In Commercial Distribution

  • 08800011120221 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120214

480V3~ / 150kV
DRGEM Corporation
GXR-68S
In Commercial Distribution

  • 08800011120214 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120207

480V3~ / 150kV
DRGEM Corporation
GXR-52S
In Commercial Distribution

  • 08800011120207 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120191

480V3~ / 150kV
DRGEM Corporation
GXR-40S
In Commercial Distribution

  • 08800011120191 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120184

480V3~ / 125kV
DRGEM Corporation
GXR-40S
In Commercial Distribution

  • 08800011120184 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120177

400V3~ / 150kV
DRGEM Corporation
GXR-40S
In Commercial Distribution

  • 08800011120177 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120160

400V3~ / 125kV
DRGEM Corporation
GXR-40S
In Commercial Distribution

  • 08800011120160 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120153

480V3~ / 150kV
DRGEM Corporation
GXR-32S
In Commercial Distribution

  • 08800011120153 ()


  • 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

DRGEM - 08800011170004

Digital Imaging Software
DRGEM Corporation
RADMAX
In Commercial Distribution

  • 08800011170004 ()


  • Basic diagnostic 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

GXR-ES,ECS Diagnostic X-ray System - 08800011121907

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

GXR-ES,ECS Diagnostic X-ray System - 08800011121891

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

GXR-ES,ECS Diagnostic X-ray System - 08800011121884

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-EC25S
In Commercial Distribution

  • 08800011121884 ()


  • Stationary basic diagnostic x-ray system, analogue

GXR-ES,ECS Diagnostic X-ray System - 08800011121877

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-EC20S
In Commercial Distribution

  • 08800011121877 ()


  • Stationary basic diagnostic x-ray system, analogue

GXR-ES,ECS Diagnostic X-ray System - 08800011121808

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-EC50S
In Commercial Distribution

  • 08800011121808 ()


  • Stationary basic diagnostic x-ray system, analogue

GXR-ES,ECS Diagnostic X-ray System - 08800011121792

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-EC40S
In Commercial Distribution

  • 08800011121792 ()


  • Stationary basic diagnostic x-ray system, analogue

GXR-ES,ECS Diagnostic X-ray System - 08800011121785

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-EC32S
In Commercial Distribution

  • 08800011121785 ()


  • Stationary basic diagnostic x-ray system, analogue

GXR-ES,ECS Diagnostic X-ray System - 08800011121778

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-EC25S
In Commercial Distribution

  • 08800011121778 ()


  • Stationary basic diagnostic x-ray system, analogue

GXR-ES,ECS Diagnostic X-ray System - 08800011121761

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-EC20S
In Commercial Distribution

  • 08800011121761 ()


  • Stationary basic diagnostic x-ray system, analogue

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 - 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
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