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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 Ablatherm Endorectal Probe is a primary component of the Ablatherm Integrated Imaging system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.
EDAP-TMS FRANCE
EDP 900900
Not in Commercial Distribution

  • 03661690000076 ()
EDP 900900

  • Physical therapy ultrasound system
The Focalpak is the single use kit of consumables to support a single patient procedure using the Focal One system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.
EDAP-TMS FRANCE
TMS 239305
Not in Commercial Distribution

  • 03661690000069 ()
TMS 239305

  • Physical therapy ultrasound system
The Ablapak is he single use kit of consumables to support a single patient procedure using the Ablatherm Integrated Imaging system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.
EDAP-TMS FRANCE
TMS 227710
Not in Commercial Distribution

  • 03661690000014 ()


  • Physical therapy ultrasound system
The KKT-M2 device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the total care of the patient. The procedure involves the use of diagnostic imaging that qualifies the misalignment between vertebrae. The treatment is then administered using the KKT-M2 device to deliver precise impulses at a required vector configuration.
Optima Health Solutions International Corporation
KKT-M2
In Commercial Distribution

  • B854M20 ()
M2

  • Physical therapy ultrasound system
Therasound 3.5P - Device
COMPASS HEALTH BRANDS CORP.
400-020
Not in Commercial Distribution

  • 00092237901731 ()


  • Physical therapy ultrasound system
Therasound 3 Standard Device Only (120V)
COMPASS HEALTH BRANDS CORP.
410-026
Not in Commercial Distribution

  • 00092237901236 ()
  • 01092237901235 ()


  • Physical therapy ultrasound system
Therasound EVO Device Only (220V)
COMPASS HEALTH BRANDS CORP.
410-028
In Commercial Distribution

  • 00092237901229 ()


  • Physical therapy ultrasound system
THERASOUND Evo Device Only - 120V
COMPASS HEALTH BRANDS CORP.
410-020
In Commercial Distribution

  • 00092237901212 ()


  • Physical therapy ultrasound system
Ultra Cure Pro PLUS
COMPASS HEALTH BRANDS CORP.
DU3038
In Commercial Distribution

  • 80092237618864 ()
  • 00092237618868 ()


  • Physical therapy ultrasound system
DS SoundCare Plus - Prof.
COMPASS HEALTH BRANDS CORP.
DS-ULTRSND
In Commercial Distribution

  • 80092237618727 ()
  • 00092237618721 ()


  • Physical therapy ultrasound system
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