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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 - 08800011140069

220-230V~ / 150kV
DRGEM Corporation
GXR-40SD
In Commercial Distribution

  • 08800011140069 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140052

220-230V~ / 125kV
DRGEM Corporation
GXR-40SD
In Commercial Distribution

  • 08800011140052 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140045

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

  • 08800011140045 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140038

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

  • 08800011140038 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140021

*Line power rating: 400V3~ *MAX Tube voltage: 150kV
DRGEM Corporation
DIAMOND-8A
In Commercial Distribution

  • 08800011140021 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140014

*Line power rating: 400V3~ *MAX Tube voltage: 150kV
DRGEM Corporation
DIAMOND-6A
In Commercial Distribution

  • 08800011140014 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140007

*Line power rating: 400V3~ *MAX Tube voltage: 150kV
DRGEM Corporation
DIAMOND-5A
In Commercial Distribution

  • 08800011140007 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 08806095799643

The GF85 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GF85-SP
In Commercial Distribution

  • 08806095799643 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 08806095799636

The GF85 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GF85-3P
In Commercial Distribution

  • 08806095799636 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 08806088670560

The GC70 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GC70
In Commercial Distribution

  • 08806088670560 ()


  • Stationary basic diagnostic x-ray system, digital
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