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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 EG-840N 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 product can be inserted orally or nasally. Never use this product for any other purposes.
FUJIFILM CORPORATION
EG-840N
In Commercial Distribution

  • 14547410500643 ()
  • 04547410500646 ()


  • Flexible video gastroduodenoscope
"This device is intended for the visualization of the upper and lower digestive tracts, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, large intestine and rectum. Never use this product for any other purposes. "
FUJIFILM CORPORATION
EN-840T
In Commercial Distribution

  • 14547410491712 ()
  • 04547410491715 ()


  • Flexible video enteroscope
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-1504A
In Commercial Distribution

  • 14547410484745 ()
  • 04547410484748 ()


  • Endoscopic overtube, single-use
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-1507A
In Commercial Distribution

  • 14547410484714 ()
  • 04547410484717 ()


  • Endoscopic overtube, single-use
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-1208A
In Commercial Distribution

  • 14547410484684 ()
  • 04547410484687 ()


  • Endoscopic overtube, single-use
Protective cover is placed on a flat panel sensor (DR-ID 1836SE) during recumbent exposure and is covered to reinforce the strength.
FUJIFILM CORPORATION
DR1836 SE PROTECTIVE COVER E
In Commercial Distribution

  • 04547410483437 ()

  • 470x860x25mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 1836SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1836 SE E
In Commercial Distribution

  • 04547410483420 ()

  • 460x850x15mm


  • Stationary basic diagnostic x-ray system, digital
FUJIFILM Endoscope Model EB-710P is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians.
FUJIFILM CORPORATION
EB-710P
In Commercial Distribution

  • 14547410482475 ()
  • 04547410482478 ()


  • Flexible video bronchoscope, reusable
This product is intended to inject reprocessing fluids or air during manual cleaning and manual disinfection of a FUJIFILM endoscope in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CA-616
In Commercial Distribution

  • 04547410481006 ()
  • 14547410481003 ()


  • Endoscope flushing adaptor, reusable
This product is used in medical facilities and attached to the forceps inlet of endoscope to prevent leak or backflow of air. Do not use this product for any other purpose.
FUJIFILM CORPORATION
FV-003
In Commercial Distribution

  • 14547410480990 ()
  • 04547410480993 ()


  • Endoscope working-channel valve, single-use
This product is a medical device that is attached to a FUJIFILM endoscope in order to control the suctioning of body fluids, etc. through the instrument channel of the endoscopes. Do not use this product for any other purpose.
FUJIFILM CORPORATION
SB-606
In Commercial Distribution

  • 14547410480983 ()
  • 04547410480986 ()


  • Endoscope suction valve, single-use
A foot switch with a cable to connect to DR-XD 3000FX.
FUJIFILM CORPORATION
DR-XD 3000 WIRED F/S E
In Commercial Distribution

  • 04547410480832 ()


  • Mobile general-purpose fluoroscopic 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 1832 SE NON CE E
In Commercial Distribution

  • 04547410480788 ()

  • 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 NON CE E
In Commercial Distribution

  • 04547410480771 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital
Monitor cart.
FUJIFILM CORPORATION
DR-XD 3000MX
In Commercial Distribution

  • 04547410480689 ()


  • Mobile general-purpose fluoroscopic x-ray system, digital
This kit is used to install a wireless foot switch transmitter/receiver onto DR-XD 3000FX/DR-XD 3000MX. (The wireless foot switch transmitter and receiver are included.)
FUJIFILM CORPORATION
DR-XD 3000 WIRELESS F/S E
In Commercial Distribution

  • 04547410480672 ()


  • Mobile general-purpose fluoroscopic x-ray system, digital
A flat panel sensor holder used to mount a 17" x 17" flat panel sensor onto DR-XD 3000FX.
FUJIFILM CORPORATION
DR-XD 3000 HOLDER4343 E
In Commercial Distribution

  • 04547410480665 ()

  • 546.0 mm x 589.0 mm x 90.1 mm


  • Mobile general-purpose fluoroscopic x-ray system, digital
A flat panel sensor holder used to mount a 14" x 17" flat panel sensor onto DR-XD 3000FX.
FUJIFILM CORPORATION
DR-XD 3000 HOLDER3543 E
In Commercial Distribution

  • 04547410480658 ()

  • 546.0 mm x 513.0 mm x 90.1 mm


  • Mobile general-purpose fluoroscopic x-ray system, digital
A flat panel sensor holder used to mount a 10" x 12" flat panel sensor onto DR-XD 3000FX.
FUJIFILM CORPORATION
DR-XD 3000 HOLDER2530 E
In Commercial Distribution

  • 04547410480641 ()

  • 442.8 mm x 437.0 mm x 90.1 mm


  • Mobile general-purpose fluoroscopic 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 1814 SE NON CE E
In Commercial Distribution

  • 04547410478655 ()

  • 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 NON CE E
In Commercial Distribution

  • 04547410478648 ()

  • 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 NON CE E
In Commercial Distribution

  • 04547410478631 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital
The CR-IR 392 is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410472905 ()


  • Computed radiography digital imaging scanner
The CR-IR 392 is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410472882 ()


  • Computed radiography digital imaging scanner
The FCR PRIMA T2 (CR-IR 392) is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410472820 ()


  • Computed radiography digital imaging scanner
The FCR PRIMA T2 (CR-IR 392) is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410472813 ()


  • Computed radiography digital imaging scanner
These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, dissection, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to inject saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities. Never use this product for any other purpose.
FUJIFILM CORPORATION
DK2623JI -B20-
In Commercial Distribution

  • 04547410470543 ()
  • 14547410470540 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, dissection, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to inject saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities. Never use this product for any other purpose.
FUJIFILM CORPORATION
DK2623JI -B15-
In Commercial Distribution

  • 14547410470533 ()
  • 04547410470536 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, dissection, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to inject saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities. Never use this product for any other purpose.
FUJIFILM CORPORATION
DK2623JI -N20-
In Commercial Distribution

  • 14547410470526 ()
  • 04547410470529 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, dissection, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to inject saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities. Never use this product for any other purpose.
FUJIFILM CORPORATION
DK2623JI -N15-
In Commercial Distribution

  • 14547410470519 ()
  • 04547410470512 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
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