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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 Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access System. The Controller is a portable electronic console with AC power input, internal control electronics, a Catheter connection receptacle, and LCD display. The Controller delivers power to the Catheter heating element and guides the user through the procedure with visual prompts. The power controller is only compatible with the Avenu Medical Ellipsys® Catheter.
AVENU MEDICAL, INC.
AMI1001
In Commercial Distribution

  • B357AMI1001 ()


  • Electrocautery system, line-powered
The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access System. The Controller is a portable electronic console with AC power input, internal control electronics, a Catheter connection receptacle, and LCD display. The Controller delivers power to the Catheter heating element and guides the user through the procedure with visual prompts. The power controller is only compatible with the Avenu Medical Ellipsys® Catheter.
AVENU MEDICAL, INC.
AMI1001
In Commercial Distribution

  • 00763000574710 ()


  • Electrocautery system, line-powered
The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access System. The Controller is a portable electronic console with AC power input, internal control electronics, a Catheter connection receptacle, and LCD display. The Controller delivers power to the Catheter heating element and guides the user through the procedure with visual prompts. The power controller is only compatible with the Avenu Medical Ellipsys® Catheter.
AVENU MEDICAL, INC.
AMI1001
In Commercial Distribution

  • 00763000478193 ()


  • Electrocautery system, line-powered
The VIVA combo RF System consists of RF generator, active electrode, grounding pad and peristaltic pump for electrode cooling. This device is designed to produce local tissue heating at the tip of the electrodes causing the coagulation and ablation of tissue. The VIVA combo RF System is capable of delivering up to 200 W of RF power and the available power is limited through software control. This generator monitors the power, resistance, current and temperature.
STARMED CO.,LTD
VCS10
In Commercial Distribution

  • 08809306769152 ()

  • Width: 260 Millimeter
  • Length: 348 Millimeter
  • Height: 115 Millimeter
  • Weight: 6 Kilogram
VCS10

  • Percutaneous radio-frequency ablation system generator
The VIVA combo RF System consists of RF generator, active electrode, grounding pad and peristaltic pump for electrode cooling. This device is designed to produce local tissue heating at the tip of the electrodes causing the coagulation and ablation of tissue. The VIVA combo RF System is capable of delivering up to 200 W of RF power and the available power is limited through software control. This generator monitors the power, resistance, current and temperature.
STARMED CO.,LTD
VCS10
Not in Commercial Distribution

  • 08809306769060 ()

  • Weight: 6 Kilogram
  • Height: 115 Millimeter
  • Length: 348 Millimeter
  • Width: 260 Millimeter
VCS10

  • Percutaneous radio-frequency ablation system generator
Veress Needle 120mm w/Straight Hub
ORANGE SURGICAL INSTRUMENTS, LLC
OSVN120S
Not in Commercial Distribution

  • B354OSVN120S10 ()
  • B354OSVN120S0 ()


  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
Joystick for head lamps
ORANGE SURGICAL INSTRUMENTS, LLC
OSJS
In Commercial Distribution

  • B354OSJS0 ()
OSJS

  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
No Description
ORANGE SURGICAL INSTRUMENTS, LLC
OSIS
In Commercial Distribution

  • B354OSIS0 ()
OSIS

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Tissue extraction bag
Veress Needle 150mm w/Straight Hub
ORANGE SURGICAL INSTRUMENTS, LLC
OSVN150S
Not in Commercial Distribution

  • B354OSVN150S10 ()
  • B354OSVN150S0 ()


  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Tissue extraction bag
Retrieval Pouch-Rip Stop-W/Pull Strap - 7" x 10"
ORANGE SURGICAL INSTRUMENTS, LLC
OSRP710W
Not in Commercial Distribution

  • B354OSRP710W10 ()
  • B354OSRP710W0 ()


  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
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