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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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M-2215R TMH ORIGINAL edition, Right
INAMI & CO., LTD.
M-2215R
In Commercial Distribution

  • 04547451332381 ()


  • Trabeculotome, reusable
Spatula Cannula Goniosynechialysis NAGATA Angled Type Left 25G
INAMI & CO., LTD.
M-580F
In Commercial Distribution

  • 04547451032687 ()


  • General-purpose surgical spatula
This software is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. This software is used with standard White Light Imaging (WLI) and Linked Color Imaging (LCI) endoscopy imaging. This software is not intended to replace clinical decision making.
FUJIFILM CORPORATION
EW10-EC02
In Commercial Distribution

  • 04547410541199 ()


  • Endoscopic video image interpretive software
FUJIFILM Endoscope Model EG-840T, EG-840TP is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM CORPORATION
EG-840TP
In Commercial Distribution

  • 14547410528265 ()
  • 04547410528268 ()


  • Flexible video gastroduodenoscope
FUJIFILM Endoscope Model EG-840T, EG-840TP is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM CORPORATION
EG-840T
In Commercial Distribution

  • 04547410517330 ()
  • 14547410517337 ()


  • Flexible video gastroduodenoscope
This product is inteded to be used in combination with FUJIFILM gastrointinal endoscopes and a FUJIFILM endosopic CO2 regulator to deliver CO2 gas and water.
FUJIFILM CORPORATION
AW-604G
In Commercial Distribution

  • 04547410366037 ()


  • Endoscope air/water valve, reusable
The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM CORPORATION
EG-760R
In Commercial Distribution

  • 04547410358667 ()
  • 14547410358664 ()


  • Flexible video gastroduodenoscope
This product is intended to clean the distal end and the forceps elevator mechanism of a FUJIFILM endoscope in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WB1318DE
In Commercial Distribution

  • 14547410341352 ()
  • 04547410341355 ()


  • Surgical instrument/endoscope cleaning utensil, single-use
This product is intended to clean the instrument/suction channel and accessories of a FUJIFILM endoscope in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WB7025DC
In Commercial Distribution

  • 14547410341345 ()
  • 04547410341348 ()


  • Surgical instrument/endoscope cleaning utensil, single-use
NOVEL TL, SPINAL SPACER, MEDIUM NON-LORDOTIC, 8MM
ALPHATEC SPINE, INC.
64614-008
In Commercial Distribution

  • 00844856013490 ()

  • Height: 8 Millimeter
  • Width: 10 Millimeter
  • Length: 24 Millimeter


  • Polymeric spinal interbody fusion cage
  • Vertebral body prosthesis
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