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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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A grid for 14" x 17" flat panel sensor mounted onto DR-XD 3000FX.
FUJIFILM CORPORATION
DR-XD 3000 GRID3543 E
In Commercial Distribution

  • 04547410467871 ()

  • 377 mm x 453 mm x 1.1 mm


  • Mobile general-purpose fluoroscopic x-ray system, digital
A grid for 10" x 12" flat panel sensor mounted onto DR-XD 3000FX.
FUJIFILM CORPORATION
DR-XD 3000 GRID2530 E
In Commercial Distribution

  • 04547410467857 ()

  • 275 mm x 349 mm x 1.1 mm


  • Mobile general-purpose fluoroscopic x-ray system, digital
The DR-XD 3000 is a mobile C-arm system with detachable flat panel detector, which is intended for use in providing medical imaging for general populations including pediatrics. The device provides pulsed fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures and digital radiographic imaging. It is intended for use in procedures such as holangiography, endoscopic, urologic, orthopedic, neurologic, critical care, peripheral vascular, emergency room procedures. This device does not support cardiac procedures and is not intended for use in performing mammography.
FUJIFILM CORPORATION
DR-XD 3000
In Commercial Distribution

  • 04547410467710 ()


  • Mobile general-purpose fluoroscopic x-ray system, digital
This product is used in combination with FUTIFILM Double Balloon Endoscopes at medical facilities under the management of physicians. Being attached to the endoscope, this product is inserted into the digestive tract from the mouth or anus to stabilize the distal end of the endoscope to the digestive tract's mucous membrane. Do not use this product for any other purposes. This product is not intended for use for any neonates , infants or children
FUJIFILM CORPORATION
BS-4
In Commercial Distribution

  • 14547410467281 ()
  • 04547410467284 ()


  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
This product is used in combination with a FUTIFILM Double Balloon Endoscope to assist the insertion of the Endoscope under the management of physicians in medical facilities. This product is used to assist with the movement of the scopes inside the upper or lower digestive tract. Do not use this product for any other purposes. This product is not intended for use for any neonates , infants or children
FUJIFILM CORPORATION
TS-1314B
In Commercial Distribution

  • 04547410467260 ()
  • 14547410467267 ()


  • Endoscopic overtube, single-use
This product is intended to be used in combination with FUJIFILM double balloon endoscopes to assist with insertion inside the upper or lower digestive tract at medical facilities under the management of physicians. Do not use this product for any other purpose. It is not intended for use for any neonates, infants or children.
FUJIFILM CORPORATION
BS-3
In Commercial Distribution

  • 04547410463439 ()
  • 14547410463436 ()


  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
This hood is intended to be used in combination with the dedicated endoscope to maintain the field of view during endoscopic procedures.
FUJIFILM CORPORATION
DH-32EN
In Commercial Distribution

  • 04547410458442 ()
  • 14547410458449 ()


  • Endoscope tissue removal cap, single-use
DR-ID 800 (FDR D-EVO Mobile Compo) is digital radiography equipment for mounting on the Mobile Cart and employs an indirect-conversion FPD.
FUJIFILM CORPORATION
DR-ID 800 IU DV3 E
In Commercial Distribution

  • 04547410457704 ()

  • 169×326×230mm


  • Stationary basic diagnostic x-ray system, digital
This product is a single use grasping forceps inserted into a compatible endoscope to grasp and manipulate tissue or other objects during endoscopic procedures.
FUJIFILM CORPORATION
GF3612RT
In Commercial Distribution

  • 14547410454489 ()
  • 04547410454482 ()


  • Flexible endoscopic tissue manipulation forceps, single-use
This hood is intended to be used in combination with the dedicated endoscope to maintain the field of view during endoscopic procedures.
FUJIFILM CORPORATION
DH-17EN2
In Commercial Distribution

  • 04547410450071 ()
  • 14547410450078 ()


  • Endoscope tissue removal cap, single-use
FUJIFILM Video Laparoscope EL-R740M30 is intended to be used with a video processor, light source, monitor, hand instruments, electrosurgical unit and other ancillary equipment for minimally invasive observation, diagnosis and treatment in general abdominal, gynecologic and thoracic areas.
FUJIFILM CORPORATION
EL-R740M30
In Commercial Distribution

  • 14547410449720 ()
  • 04547410449723 ()


  • Rigid video laparoscope
A hardware for installing software.
FUJIFILM CORPORATION
DR-ID1200 GPU EX-M1 MDR E
In Commercial Distribution

  • 04547410448214 ()


  • Diagnostic x-ray digital imaging conversion system
This product is intended to be used in combination with the FUJIFILM ultrasonic endoscope to enclose the ultrasonic transmission medium 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
BS-102
In Commercial Distribution

  • 14547410446149 ()
  • 04547410446142 ()
  • 84547410446148 ()


  • Ultrasound endoscope balloon, synthetic polymer
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
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