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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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The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes • precise marking of tissue • stable position of the needle without risk of dislocating during the dissection • ceramic socket as stopper and protector • opening in the ceramic socket for flushing and re-injection
Ovesco Endoscopy AG
2.0 mm
Not in Commercial Distribution


  • working length 220 cm
  • needle length 2.0 mm
  • working channel diameter 2.8 mm
200.53.02

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes • precise marking of tissue • stable position of the needle without risk of dislocating during the dissection • ceramic socket as stopper and protector • opening in the ceramic socket for flushing and re-injection
Ovesco Endoscopy AG
1.5 mm
In Commercial Distribution


  • needle length 1.5 mm
  • working channel diameter 2.8 mm
  • working length 220 cm
200.53.01

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
The Coag Dissector is a monopolar electrosurgical instrument for dissection and hemostasis using flexible endoscopes • tip design inspired by laparoscopic surgical instruments • branches for blunt dissection of tissue • good coagulation capabilities between branches • rotatable flexible shaft for precise alignment of tip orientation • curved grasper for precise targeting of the tissue • teeth provide secure grasping of the bleeding area
Ovesco Endoscopy AG
165 cm
In Commercial Distribution


  • working channel diameter 2.8 mm
  • working length 165 cm
200.50

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
The colonic FTRD Set is a novel tool for diagnostic and therapeutic full-thickness resection via flexible endoscope in colon and rectum • technology is based on OTSC System • enabling the endoscopist to resect all layers of suitable lesions including the serosa • transection of the tissue happens after the defect has been closed completely • bowel lumen and abdominal cavity won't get into contact • it consists of the following three instruments: colonic FTRD (application cap with preloaded clip and integrated HF snare | endoscope sleeve, hand wheel and thread retriever | for colonoscopes) • FTRD Marking Probe (HF coagulation probe | marking of the target lesion in preparation of FTRD use | for detection and complete resection of the right tissue) • FTRD Grasper (specially designed grasping forceps | proper grip on the target tissue | precise retrieval of the sample into the application cap of the FTRD)
Ovesco Endoscopy AG
14
In Commercial Distribution


  • for endoscopes diameter 11.5-13.2 mm
  • working channel diameter 2.8 mm
  • working length 220 cm
200.70

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Endoscopic electrosurgical full-thickness tissue biopsy/resection set
ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
FUJI SYSTEMS CORPORATION
I.D. 7.5MM
In Commercial Distribution

  • 14544050123867 ()
  • 04544050123860 ()
  • 04544050056038 ()
1202931

  • Endobronchial tube
ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
FUJI SYSTEMS CORPORATION
I.D. 6.5MM
In Commercial Distribution

  • 14544050123843 ()
  • 04544050123846 ()
  • 04544050056014 ()
1202928

  • Endobronchial tube
ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
FUJI SYSTEMS CORPORATION
I.D. 4.5MM, WITH CUFF
In Commercial Distribution

  • 14544050123829 ()
  • 04544050123822 ()
  • 04544050055161 ()
1202720

  • Endobronchial tube
ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
FUJI SYSTEMS CORPORATION
I.D. 8.0MM
In Commercial Distribution

  • 14544050123812 ()
  • 04544050123815 ()
  • 04544050056045 ()
1202933

  • Endobronchial tube
ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
FUJI SYSTEMS CORPORATION
I.D. 3.5MM, WITHOUT CUFF
In Commercial Distribution

  • 14544050123805 ()
  • 04544050123808 ()
  • 04544050055154 ()
1202716

  • Endobronchial tube
The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
FUJI SYSTEMS CORPORATION
1610590
In Commercial Distribution

  • 14544050120743 ()
  • 04544050120746 ()
  • 04544050093491 ()

  • 9F
  • Outer Diameter: 3.0 Millimeter
  • Catheter Inner Diameter: 2.15 Millimeter
  • Shaft Length: 920 Millimeter


  • Intravascular occluding balloon catheter, image-guided
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