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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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This product is intended to be used for connecting the FUJFILM ultrasonic endoscope and the ultrasonic processor to transmit ultrasonic drive and image signals in medical facilities under the management of physicians. Do not use this product for any other purpose. This product is not intended for use on children and infants.
FUJIFILM CORPORATION
UC-01
In Commercial Distribution

  • 04547410446128 ()


  • Electrical-only medical device connection cable, reusable
The Image Processing Unit EX-0 is an optional module intended for use as an adjunctive monitor of the hemoglobin oxygen saturation of blood in superficial tissue of the endoscopic observation image area in patients at risk for ischemic states. This product may be used on all patients requiring endoscopic examination when using a Fujinon/FUJIFILM medical endoscope, video processor and light source together with monitor, recorder and various peripheral devices. The prospective clinical value of measurements made with OXEI has not been demonstrated in disease states.
FUJIFILM CORPORATION
EX-0
In Commercial Distribution

  • 04547410446104 ()


  • Tissue saturation oximeter
The BL-7000X Light Source is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination. This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and video processor together with monitor, recorder and various peripheral devices
FUJIFILM CORPORATION
BL-7000X
In Commercial Distribution

  • 04547410446081 ()


  • Endoscopic light source unit, line-powered
This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree under the management of physicians at medical facilities. Modes of Operation: B-mode Never use this product for any other purposes
FUJIFILM CORPORATION
PB2020-M2
In Commercial Distribution

  • 04547410445886 ()


  • Surgical ultrasound imaging transducer
The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1814 SE E
In Commercial Distribution

  • 04547410445503 ()

  • 333x282x15mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1812 SE E
In Commercial Distribution

  • 04547410445480 ()

  • 460x460x15mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1811 SE E
In Commercial Distribution

  • 04547410445466 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 1831SE and DR-ID 1832SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1832 SE E
In Commercial Distribution

  • 04547410445442 ()

  • 460x460x15mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 1831SE and DR-ID 1832SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1831 SE E
In Commercial Distribution

  • 04547410445428 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital
This product is used to insert an endotherapy device and to reduce the spread of patient's droplets toward the operator side with the drape and sponge while using an endoscope under the management of a physician in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
P1
In Commercial Distribution

  • 14547410440765 ()
  • 04547410440768 ()


  • Medical equipment/instrument drape, single-use
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