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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 in combination with an endoscope to assist endoscopic insertion into the body. Never use this product for any other purpose. This product is intended for use in medical facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments.
FUJIFILM CORPORATION
TR-1108A
In Commercial Distribution

  • 04547410543858 ()
  • 14547410543855 ()


  • Endoscopic overtube, 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

  • 04547410536003 ()


  • Mobile basic diagnostic x-ray system, digital
This hood is 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-083ST
In Commercial Distribution

  • 14547410532873 ()
  • 04547410532876 ()


  • Endoscope tissue removal cap, single-use
This product is used to charge Li-Polymer Battery set in this product.
FUJIFILM CORPORATION
DR1280 SE BATTERY CHARGER E
In Commercial Distribution

  • 04547410530667 ()


  • Diagnostic x-ray digital imaging conversion system
The product is used to supply power for SE.
FUJIFILM CORPORATION
DR1280 SE BATTERY E
In Commercial Distribution

  • 04547410530650 ()


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1280PB supplies the power to the flat panel sensor connected by a medical professional and establishes intercommunication between the flat panel sensor and the image processing unit connected beforehand. Also, it transfers images acquired by the flat panel sensor to the image processing unit.
FUJIFILM CORPORATION
DR-ID 1280 PB E
In Commercial Distribution

  • 04547410530643 ()


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1280MP supplies the power to the flat panel sensor connected by a medical professional and establishes intercommunication between the flat panel sensor and the image processing unit connected beforehand. Also, it transfers images acquired by the flat panel sensor to the image processing unit.
FUJIFILM CORPORATION
DR-ID 1280 MP E
In Commercial Distribution

  • 04547410530636 ()


  • Diagnostic x-ray digital imaging conversion system
The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat Panel Sensor (DR-ID 128xSE) is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1285 SE E
In Commercial Distribution

  • 04547410530629 ()


  • Diagnostic x-ray digital imaging conversion system
The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat Panel Sensor (DR-ID 128xSE) is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1284 SE E
In Commercial Distribution

  • 04547410530612 ()


  • Diagnostic x-ray digital imaging conversion system
The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat Panel Sensor (DR-ID 128xSE) is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1283 SE E
In Commercial Distribution

  • 04547410530605 ()


  • Diagnostic x-ray digital imaging conversion system
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