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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 device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
FUJIFILM CORPORATION
EC-530HL V2
In Commercial Distribution

  • 04547410341287 ()


  • Flexible video colonoscope, reusable
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

  • 04547410339161 ()


  • Mobile basic diagnostic x-ray system, digital
This device provides illumination to an endoscope and supplies air and water to body cavities via the endoscope, and is intended to provide images captured by the endoscope for endoscopic procedure.
FUJIFILM CORPORATION
BL-7000
In Commercial Distribution

  • 04547410337730 ()


  • Endoscopic light source unit, line-powered
The VP-7000 unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and light source together with monitor, recorder and various peripheral devices. BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examination 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.
FUJIFILM CORPORATION
VP-7000
In Commercial Distribution

  • 04547410337419 ()


  • Endoscopic video image processing unit
These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.
FUJIFILM CORPORATION
DK2623J -B15-
In Commercial Distribution

  • 04547410334586 ()
  • 14547410334583 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.
FUJIFILM CORPORATION
DK2618J -N30-
In Commercial Distribution

  • 04547410334579 ()
  • 14547410334576 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.
FUJIFILM CORPORATION
DK2618J -N25-
In Commercial Distribution

  • 04547410334562 ()
  • 14547410334569 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.
FUJIFILM CORPORATION
DK2618J -N20-
In Commercial Distribution

  • 04547410334555 ()
  • 14547410334552 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.
FUJIFILM CORPORATION
DK2618J -N15-
In Commercial Distribution

  • 04547410334548 ()
  • 14547410334545 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
A battery charger for the battery pack.
FUJIFILM CORPORATION
DR1200 SE BATTERY CHARGER A E
In Commercial Distribution

  • 04547410333374 ()


  • Diagnostic x-ray digital imaging conversion system
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