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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 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
DK2620JI -N25-
In Commercial Distribution

  • 14547410470458 ()
  • 04547410470451 ()


  • 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
DK2620JI -N20-
In Commercial Distribution

  • 14547410470441 ()
  • 04547410470444 ()


  • 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
DK2620JI -N15-
In Commercial Distribution

  • 04547410470437 ()
  • 14547410470434 ()


  • 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
DK2620JI -N10-
In Commercial Distribution

  • 04547410470420 ()
  • 14547410470427 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
A grid for 17" x 17" flat panel sensor mounted onto DR-XD 3000FX.
FUJIFILM CORPORATION
DR-XD 3000 GRID4343 E
In Commercial Distribution

  • 04547410467888 ()

  • 453 mm x 453 mm x 1.1 mm


  • Mobile general-purpose fluoroscopic x-ray system, digital
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
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