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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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The KMC-650 is a great solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and the image intensifier. This system can be applied in emergency room, operation room, cast room or etc. of hospital.
GEMSS MEDICAL SYSTEMS CO.,LTD.
KMC-650
In Commercial Distribution

  • 08809246620025 ()
KMC-650

  • Mobile general-purpose fluoroscopic x-ray system, digital
The SPINEL 3G is a great solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and the image intensifier. This system can be applied in emergency room, operation room, cast room or etc. of hospital.
GEMSS MEDICAL SYSTEMS CO.,LTD.
SPINEL 3G
In Commercial Distribution

  • 08809246620018 ()
SPINEL 3G

  • Mobile general-purpose fluoroscopic x-ray system, digital
The KMC-950 is a great solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and the image intensifier. This system can be applied in emergency room, operation room, cast room or etc. of hospital.
GEMSS MEDICAL SYSTEMS CO.,LTD.
KMC-950
In Commercial Distribution

  • 08809246620001 ()
KMC-950

  • Mobile general-purpose fluoroscopic x-ray system, digital
Breathing Circuit and Nose Clip, Single Use, 10 pieces each
MEDIPINES CORPORATION
MPSK10
In Commercial Distribution

  • 00860001261530 ()
  • 00860001261554 ()
MPSK10

  • Nose clip, single-use
  • Breathing mouthpiece, single-use
Breathing Circuit Kit, Single Patient Use, 10
MEDIPINES CORPORATION
AGM316
In Commercial Distribution

  • 00860001261516 ()
  • 00860001261523 ()
  • 00860001261547 ()
  • 00860001261561 ()
AGM316-10, AGM316-50, AGM316-100

  • Breathing mouthpiece, single-use
The MediPines Gas Exchange Monitor (GEM) is a non-invasive, multi-parameter respiratory monitoring device that provides spot-check respiratory gas measurements of oxygen (PO2, ETO2) and carbon dioxide (PCO2, ETCO2) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices.
MEDIPINES CORPORATION
AGM100
In Commercial Distribution

  • 00860001261509 ()
AGM100

  • Multiple vital physiological parameter monitoring system, clinical
  • Respiration monitor
  • Patient monitoring system module, multiple-gas
A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.
LINKQUEST INC.
LQ-A3D1
In Commercial Distribution

  • 00860000784856 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.
LINKQUEST INC.
LQ-A3S1
In Commercial Distribution

  • 00860000784849 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
An invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It is intended for use with a dedicated ultrasound system with dedicated software installed. This is a reusable device.
LINKQUEST INC.
LQ-E8C1
In Commercial Distribution

  • 00860000784832 ()


  • Rectal/vaginal ultrasound imaging transducer
A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.
LINKQUEST INC.
LQ-A3C1
In Commercial Distribution

  • 00860000784825 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
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