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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 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
This device is intended to be used with a video processor, light sourse, monitor, hand instruments, electorosurgical unit and other ancillary equipment for minimally invasive observation, diagnosis and treatment in general abdominal, gynecologic and thoracic areas.
FUJIFILM CORPORATION
EL-R740M
In Commercial Distribution

  • 04547410438956 ()
  • 14547410438953 ()


  • Rigid video laparoscope
This product is exclusively used for manual cleaning and manual disinfection of a FUJIFILM endoscope in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CA-617
In Commercial Distribution

  • 04547410438673 ()
  • 24547410438677 ()


  • Luminal device flushing tubing set, reusable
This product is inteded to supply air, water or detergent slution to the air/water channel during manual cleaning of a FUJIFILM endoscope in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CA-614
In Commercial Distribution

  • 24547410438608 ()
  • 04547410438604 ()


  • Luminal device flushing tubing set, reusable
An access point used for wireless communication between the flat panel sensor and the image processing unit.
FUJIFILM CORPORATION
DR-ID 1200 AP KIT MDR E
In Commercial Distribution

  • 04547410438352 ()


  • Diagnostic x-ray digital imaging conversion system
A battery pack for the flat panel sensor.
FUJIFILM CORPORATION
DR1800 SE BATTERY S E
In Commercial Distribution

  • 04547410436983 ()


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1213 SE W SDK E
In Commercial Distribution

  • 04547410436723 ()

  • 328x268x15mm


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1212 SE W SDK E
In Commercial Distribution

  • 04547410436716 ()

  • 460x460x15mm


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1211 SE W SDK E
In Commercial Distribution

  • 04547410436709 ()

  • 460x384x15mm


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1202 SE W SDK E
In Commercial Distribution

  • 04547410436693 ()

  • 460x460x15mm


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1201 SE W SDK E
In Commercial Distribution

  • 04547410436686 ()

  • 460x384x15mm


  • Diagnostic x-ray digital imaging conversion system
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
The DR-XD 1000 (FDR AQRO) is a digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. The DR-XD 1000 is not intended for mammography applications.
FUJIFILM CORPORATION
DR-XD 1000
In Commercial Distribution

  • 04547410425505 ()


  • Mobile basic diagnostic x-ray system, digital
This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. Never use this product for any other purposes.
FUJIFILM CORPORATION
EC-760S-A/L
In Commercial Distribution

  • 14547410425175 ()
  • 04547410425178 ()


  • Flexible video colonoscope, reusable
This device is intended to be used with a video processor, light sourse, monitor, hand instruments, electorosurgical unit and other ancillary equipment for minimally invasive observation, diagnosis and treatment in general abdominal, gynecologic and thoracic areas.
FUJIFILM CORPORATION
EL-R740S
In Commercial Distribution

  • 14547410420682 ()
  • 04547410420685 ()


  • Rigid video laparoscope
FUJIFILM Ultrasonic Endoscope EG-740UT is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. This product is intended to be used with a FUJIFILM ultrasonic processor. This product is not intended for use on children and infants.
FUJIFILM CORPORATION
EG-740UT
In Commercial Distribution

  • 14547410416173 ()
  • 04547410416176 ()


  • Flexible ultrasound gastroduodenoscope
The device is intended for the observation, diagnosis, and endoscopic treatment of trachea and bronchial tree
FUJIFILM CORPORATION
EB-580T
In Commercial Distribution

  • 14547410400394 ()
  • 04547410400397 ()


  • Flexible video bronchoscope, reusable
The device is intended for the observation, diagnosis, and endoscopic treatment of trachea and bronchial tree
FUJIFILM CORPORATION
EB-580S
In Commercial Distribution

  • 14547410400387 ()
  • 04547410400380 ()


  • Flexible video bronchoscope, reusable
This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
FUJIFILM CORPORATION
EC-760S-V/L
In Commercial Distribution

  • 14547410397649 ()
  • 04547410397642 ()


  • Flexible video colonoscope, reusable
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