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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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FUJIFILM Endoscope Model EI-740D/S is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. This device is also intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.
FUJIFILM CORPORATION
EI-740D/S
In Commercial Distribution

  • 04547410436501 ()
  • 14547410436508 ()


  • Flexible video upper/lower gastrointestinal endoscope
This product is intended to attach a balloon to a FUJIFILM endoscope in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
BA-03
In Commercial Distribution

  • 24547410432583 ()
  • 04547410432589 ()


  • Endoscope balloon positioner, reusable
The DRYPIX Smart is a device that prints digital image data, transferred via the DICOM network from the FCR/FDR Image Reader or DR, CT, MRI and other imaging modalities, onto a film.
FUJIFILM CORPORATION
DRYPIX SMART II : E
In Commercial Distribution

  • 04547410431957 ()


  • Diagnostic-imaging multiformat camera
A battery charger for the battery pack.
FUJIFILM CORPORATION
DR1200 SE BATTERY CHARGER B E
In Commercial Distribution

  • 04547410431599 ()


  • Stationary basic diagnostic x-ray system, digital
This product is a distal end rubber cap required to be attached to certain FUJFIILM endoscopes during clinical use to assist in providing atraumatic passage of the endoscope tip during endoscopic procedures. Do not use this product for any other purposes.
FUJIFILM CORPORATION
DC-08D
In Commercial Distribution

  • 14547410429043 ()
  • 04547410429046 ()


  • Flexible video duodenoscope, reusable
This interface cable is intended to be used for connecting the BL-7000 to the VP-7000 and Camera Control Unit FV series via Communication Adapter.
FUJIFILM CORPORATION
CC7-301
In Commercial Distribution

  • 04547410427059 ()


  • Electrical-only medical device connection cable, reusable
A battery pack for the flat panel sensor.
FUJIFILM CORPORATION
DR1800 SE BATTERY E
In Commercial Distribution

  • 04547410426922 ()


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 1801SE and DR-ID 1802SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1802 SE E
In Commercial Distribution

  • 04547410426915 ()

  • 460x460x15mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 1801SE and DR-ID 1802SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1801 SE E
In Commercial Distribution

  • 04547410426908 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital
This product is attached to the instrument channel inlet of a FUJIFILM endoscope at medical facilities under the management of physicians. It is intended to insert an endotherapy device, to prevent leak or backflow of air and/or fluids and to enable the suction function of an endoscope. Do not use this product for any other purpose.
FUJIFILM CORPORATION
FV-002
In Commercial Distribution

  • 24547410426384 ()
  • 04547410426380 ()
  • 84547410426386 ()


  • Endoscope working-channel valve, single-use
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