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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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Slit Lamp HS-5000 - 08800019600008

-. Magnfication : 5 position rotation drum -. Lamp : Halogen Bulb ( 12V 30W )
Huvitz Co., Ltd.
HS-5000
In Commercial Distribution

  • 08800019600008 ()
HS-5000

  • Ophthalmic examination slit lamp

Digital Refractor HDR-7000P - 08800019600817

Digital Refractor system is a computerized auto refractor used for subjective refraction by regarding the patient’s accommodation power and facilities.
Huvitz Co., Ltd.
HDR-7000P
In Commercial Distribution

  • 08800019600817 ()
HDR-7000P

  • Phoropter

DHX-70H - 08800021800137

The portable x-ray system, DHX-70H is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software. And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
DigiMed Co., Ltd.
1
In Commercial Distribution

  • 18800021800134 ()
  • 08800021800137 ()
  • 28800021800131 ()
  • 38800021800138 ()
  • 48800021800135 ()
  • 58800021800132 ()
  • 68800021800139 ()
  • 78800021800136 ()
  • 88800021800133 ()


  • Diagnostic x-ray system generator, portable

XTG PRO 70 - 08800021800120

The portable x-ray system, HYBRID Pro is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software. And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
DigiMed Co., Ltd.
HYBRID Pro
In Commercial Distribution

  • 18800021800127 ()
  • 08800021800120 ()
  • 28800021800124 ()
  • 38800021800121 ()
  • 48800021800128 ()
  • 58800021800125 ()
  • 68800021800122 ()
  • 78800021800129 ()
  • 88800021800126 ()


  • Diagnostic x-ray system generator, portable

xm-lite - 08800021800113

The portable x-ray system, HYBRID C70 is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software. And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
DigiMed Co., Ltd.
HYBRID C70
In Commercial Distribution

  • 18800021800110 ()
  • 08800021800113 ()
  • 28800021800117 ()
  • 38800021800114 ()
  • 48800021800111 ()
  • 58800021800118 ()
  • 68800021800115 ()
  • 78800021800112 ()
  • 88800021800119 ()


  • Diagnostic x-ray system generator, portable

HYBRID S70 - 08800021800106

The portable x-ray system, HYBRID S70 is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software. And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
DigiMed Co., Ltd.
1
In Commercial Distribution

  • 18800021800103 ()
  • 08800021800106 ()
  • 28800021800100 ()
  • 38800021800107 ()
  • 48800021800104 ()
  • 58800021800101 ()
  • 68800021800108 ()
  • 78800021800105 ()
  • 88800021800102 ()


  • Diagnostic x-ray system generator, portable

BIOX - 08800021800045

The portable x-ray system, BIOX is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software. And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
DigiMed Co., Ltd.
1
In Commercial Distribution

  • 18800021800042 ()
  • 08800021800045 ()
  • 28800021800049 ()
  • 38800021800046 ()
  • 48800021800043 ()
  • 58800021800040 ()
  • 68800021800047 ()
  • 78800021800044 ()
  • 88800021800041 ()


  • Diagnostic x-ray system generator, portable

MiniX-V - 08800021800038

The MiniX-V is a hand-held diagnostic dental x-ray system. It is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source producing diagnostic X-ray images using with intra-oral image receptors. Its use is intended for adults and pediatric subjects both. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The system helps to get sharp and clear x-ray images, and its low radiation dosage keeps patients and dentists safe from leakage radiation.
DigiMed Co., Ltd.
1
In Commercial Distribution

  • 88800021800034 ()
  • 08800021800038 ()
  • 78800021800037 ()
  • 68800021800030 ()
  • 58800021800033 ()
  • 48800021800036 ()
  • 38800021800039 ()
  • 28800021800032 ()
  • 18800021800035 ()
DMC-07

  • Hand-held intraoral dental x-ray system, digital

MiniX-S - 08800021800021

The MiniX-S is an x-ray generating device which is mainly designed for dental examination. The device has an x-ray tube for generating x-rays, a high voltage transformer for generating high voltages, a high voltage rectification circuit for transforming and boosting AC voltage to mixed pulse voltage, a high voltage divide circuit for lowering high voltage to low voltage to measure and calibrate high voltages, as well as a high voltage tube tank, a high frequency inverter circuit for generating high voltages, a control P.C.B for controlling, saving and displaying the data, a power P.C.B for supplying power to the circuit and apparatus in housing, user interface (LCD screen) and beam limiting part (x-ray emitting cone). The apparatuses above can be embedded in one or several cases, and except for the radiation opening in the x-ray system, all units are completely shielded by lead or high-density materials, protecting patients and users from unnecessary exposure of radiation. The device is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source producing diagnostic X-ray images using with intra-oral image receptors. Its use is intended for adults and pediatric subjects both.
DigiMed Co., Ltd.
1
In Commercial Distribution

  • 88800021800027 ()
  • 08800021800021 ()
  • 78800021800020 ()
  • 68800021800023 ()
  • 58800021800026 ()
  • 48800021800029 ()
  • 38800021800022 ()
  • 28800021800025 ()
  • 18800021800028 ()
1

  • Hand-held intraoral dental x-ray system, digital

DIOX-602 - 08800021800014

The DIOX-602 is a hand-held diagnostic dental x-ray system. It is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source producing diagnostic X-ray images using with intra-oral image receptors. Its use is intended for adults and pediatric subjects both. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The system helps to get sharp and clear x-ray images, and its low radiation dosage keeps patients and dentists safe from leakage radiation.
DigiMed Co., Ltd.
1
In Commercial Distribution

  • 08800021800014 ()
  • 48800021800012 ()
  • 38800021800015 ()
  • 28800021800018 ()
  • 18800021800011 ()
  • 58800021800019 ()
  • 78800021800013 ()
  • 88800021800010 ()
  • 68800021800016 ()
DDC-03

  • Hand-held intraoral dental x-ray system, digital
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