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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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BSD-2000 Hyperthermia System - 08644450004038

The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has been shown to increase the sensitivity of tumor cells to radiation or chemotherapy by the external application of electromagnetic energy. The system provides hyperthermia to solid tumors by generating and applying radio frequency (RF) energy.
Pyrexar Medical Inc.
BSD-2000B
Not in Commercial Distribution



  • Microwave hyperthermia system

Cool-tip - 10884521165779

RFA Switching Controller
Covidien LP
CTSW Control ZD
In Commercial Distribution

  • 10884521165779 ()


  • Tumour-therapy radio-frequency hyperthermia system

Cool-tip - 10884524002781

RFA Generator,220 V
Covidien LP
CTRF 220
Not in Commercial Distribution

  • 10884524002781 ()


  • Tumour-therapy radio-frequency hyperthermia system

Cool-tip - 10884524002774

RFA Generator,100 V
Covidien LP
CTRF 100
Not in Commercial Distribution

  • 10884524002774 ()


  • Tumour-therapy radio-frequency hyperthermia system

Emprint HP - 10884521850033

Ablation Generator with Thermosphere Technology 150W;Caution: For manufacturing, processing, or repacking.
Covidien LP
CAGENHP
In Commercial Distribution

  • 10884521850033 ()

  • Power,150,Watt;


  • Microwave hyperthermia system

Emprint HP - 10884521813014

Ablation Generator with Thermosphere (TM) Technology
Covidien LP
CAGENHPZD
In Commercial Distribution

  • 10884521813014 ()

  • Power, 150, W;


  • Microwave hyperthermia system

HS AMICA - 08033055149280

AMICA-GEN MW/RF GENERATOR 140W/200W
H.S. HOSPITAL SERVICE SPA
AMICA-GEN
In Commercial Distribution

  • 08033055149280 ()
AGN-H-1.0

  • Microwave hyperthermia system

HS AMICA - 08033055149273

AMICA-GEN MW GENERATOR 140W
H.S. HOSPITAL SERVICE SPA
AMICA-GEN
In Commercial Distribution

  • 08033055149273 ()

  • Height: 13 Centimeter
  • Width: 47 Centimeter
  • Depth: 35 Centimeter
  • Weight: 10.5 Kilogram
AGN-3.0

  • Microwave hyperthermia system

Prolieve - B0638808260

Prolieve Thermodilatation Single Use Kit
Medifocus, Inc.
Coude Tip Catheter
In Commercial Distribution

  • B0638808260 ()


  • Microwave hyperthermia system

Prolieve - B0638808060

Prolieve Thermodilatation System
Medifocus, Inc.
Original
In Commercial Distribution

  • B0638808060 ()


  • Microwave hyperthermia system
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