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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 medical diode laser(UTU3-G7B) is a surgical and therapeutic device designated for a wide variety of oral soft tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain.The device utilizes a solid state diode as laser energy source.The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The device is activated by means of a footswitch.The UTU3-G7B employ the diodes with wavelengths of 980nm, 650nm and 450nm,it emits laser output energy in the infrared, red and blue spectra respectively.
Wuhan Pioon Technology Co., Ltd.
UTU3-G7B
In Commercial Distribution

  • 06974624062109 ()


  • General/multiple surgical diode laser system
Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories. The Indiba Activ CT9 device is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions.
INDIBA SA.
ACT0309
In Commercial Distribution

  • 08434251003640 ()
ACT0309BLKUSA

  • Medium-wave diathermy treatment system
The remOVE DC Cutter Set 12 consists of the following products: remOVE DC Cutter is a bipolar endoscopic direct current (DC) instrument for fragmentation of OTSC and FTRD clips in the digestive tract • consists of an insulated conducting wire with an exposed tip • intended to conduct the direct current (DC) supplied by the remOVE DC Impulse to a previously implanted clip • separation of the clip through resistive heating • remOVE DC Cutter is designed to be used only with the remOVE DC Impulse and flexible endoscopes | remOVE SecureCap 12 is an elastic and transparent retrieval cap for safe extraction of the clip fragments | remOVE Grasper is a grasping forceps for retrieval of clip fragments into the remOVE SecureCap • for removal of these fragments out of the GI tract
Ovesco Endoscopy AG
12
In Commercial Distribution

  • 04260206310938 ()

  • for endoscopes diameter 9.5-12 mm
  • working length 220 cm
  • working channel diameter 2.8 mm
400.02.01s

  • Gastrointestinal endoscopic clip cutter
  • Endoscope tissue removal cap, single-use
  • Flexible endoscopic tissue manipulation forceps, single-use
The remOVE DC Cutter Set 14 is part of the remOVE System and consists of the following products: remOVE DC Cutter is a bipolar endoscopic direct current (DC) instrument for fragmentation of OTSC and FTRD clips in the digestive tract • consists of an insulated conducting wire with an exposed tip • intended to conduct the direct current (DC) supplied by the remOVE DC Impulse to a previously implanted clip • separation of the clip through resistive heating • remOVE DC Cutter is designed to be used only with the remOVE DC Impulse and flexible endoscopes | remOVE SecureCap 14 is an elastic and transparent retrieval cap for safe extraction of the clip fragments | remOVE Grasper is a grasping forceps for retrieval of clip fragments into the remOVE SecureCap • for removal of these fragments out of the GI tract
Ovesco Endoscopy AG
14
In Commercial Distribution

  • 04260206310921 ()

  • for endoscopes diameter 12-14 mm
  • working length 220 cm
  • working channel diameter 2.8 mm
400.02.02s

  • Flexible endoscopic tissue manipulation forceps, single-use
  • Endoscope tissue removal cap, single-use
  • Gastrointestinal endoscopic clip cutter
HVT 2.0 NO DPC
VAPOTHERM, INC.
HVT-NODPC
In Commercial Distribution

  • 10841737104015 ()
  • 00841737104018 ()


  • Electrical mains power cable
  • Respiratory oxygen sensor
  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 Disposable Patient Circuit
VAPOTHERM, INC.
HVT-DPC
In Commercial Distribution

  • 00841737103998 ()
  • 10841737103995 ()


  • Electrical mains power cable
  • Respiratory oxygen sensor
  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 Transfer Kit
VAPOTHERM, INC.
HVT-Transfer-Kit
In Commercial Distribution

  • 00841737103981 ()


  • Electrical mains power cable
  • Respiratory oxygen sensor
  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 Disposable Patient Circuit
VAPOTHERM, INC.
HVT 2.0-DPC
In Commercial Distribution

  • 10841737103919 ()
  • 00841737103912 ()


  • Electrical mains power cable
  • Respiratory oxygen sensor
  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 Unit (Populated, Nellcor)
VAPOTHERM, INC.
HVT 2.0NEL-UNIT
In Commercial Distribution

  • 00841737103905 ()


  • Electrical mains power cable
  • Respiratory oxygen sensor
  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 Unit (Populated, Masimo)
VAPOTHERM, INC.
HVT 2.0MAS-UNIT
In Commercial Distribution

  • 00841737103899 ()


  • Electrical mains power cable
  • Respiratory oxygen sensor
  • Professional high-flow respiratory unit, humidifying, manual
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