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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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These hoods are intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
FUJIFILM CORPORATION
DH-34CR
In Commercial Distribution

  • 04547410395112 ()
  • 14547410395119 ()


  • Endoscope tissue removal cap, single-use
These hoods are intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
FUJIFILM CORPORATION
DH-33GR
In Commercial Distribution

  • 04547410395105 ()
  • 14547410395102 ()


  • Endoscope tissue removal cap, single-use
This product is intended to be used in combination with FUJIFILM ultrasonic processor SU-1 PLATINUM/SU-1 to operate the processor's functions. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CP-1TB
In Commercial Distribution

  • 04547410389005 ()


  • Computer/medical device keyboard
This product is intended to be used in combination with FUJIFILM ultrasonic processor SU-1 PLATINUM/SU-1 to operate the processor's functions. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CP-1
In Commercial Distribution

  • 04547410388992 ()


  • Computer/medical device keyboard
The EP-6000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording. This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals. It supplies air through the endoscope, for obtaining clear visualization and is used for endoscopic observation, diagnosis and treatment. BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examinations which can be used to supplement Fujifilm white light endoscopy. BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis. BLI, LCI, and FICE are not intended for bronchoscopic examination.
FUJIFILM CORPORATION
EP-6000
In Commercial Distribution

  • 04547410384543 ()


  • Endoscopic video image processing/light source system
The Wired/Wireless FDR ES (DR-ID1270) flat panel sensor system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. It is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1274 SE E
In Commercial Distribution

  • 04547410361377 ()

  • 460x460x15mm


  • Stationary basic diagnostic x-ray system, digital
The Wired/Wireless FDR ES (DR-ID1270) flat panel sensor system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. It is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1273 SE E
In Commercial Distribution

  • 04547410361360 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital
The Wired/Wireless FDR ES (DR-ID1270) flat panel sensor system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. It is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1272 SE E
In Commercial Distribution

  • 04547410361353 ()

  • 460x460x15mm


  • Stationary basic diagnostic x-ray system, digital
The Wired/Wireless FDR ES (DR-ID1270) flat panel sensor system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. It is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1271 SE E
In Commercial Distribution

  • 04547410361346 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital
A battery pack for the flat panel sensor.
FUJIFILM CORPORATION
DR1270 SE BATTERY E
In Commercial Distribution

  • 04547410355420 ()


  • Stationary basic diagnostic x-ray system, digital
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