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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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Neuro Patient Accessory Kit - 07290015461238

a single use kit for a neuro FUS clinical treatment contains: Description QTY Cat. No. EXABLATE NEURO DQA PHANTOM GEL SET 1 SET000932 EXABLATE NEURO ACCESSORIES SET 1 SET400187 EXABLATE NEURO CLEANING KIT 1 SET000933
INSIGHTEC LTD
Neuro Patient Accessory Kit
In Commercial Distribution

  • 07290015461238 ()
SET400186

  • Therapeutic oncological/gynaecological ultrasound system

HEAD RING SCREWS LONG - 07290015461221

Ong single use screws connecting stereotactic frame with patient skull during neuro MRI guided FUS treatment.
INSIGHTEC LTD
HEAD RING SCREWS LONG
In Commercial Distribution

  • 07290015461221 ()
MPR000444

  • Therapeutic oncological/gynaecological ultrasound system

Exablate DQA Phantom Gel - 07290015461214

Tissue mimic phantom gel for DQA for Body applications
INSIGHTEC LTD
DQA phantom Body
In Commercial Distribution

  • 07290015461214 ()
SET000885

  • Therapeutic oncological/gynaecological ultrasound system

NEURO DQA PHANTOM GEL - 07290015461207

DQA phantom (tissue mimic) gel for calibration prior neuro MR-guided FUS treatment. a part of 1.5T neuro kit (SET000937) and 3T neuro kit (SET000936)
INSIGHTEC LTD
NEURO DQA PHANTOM GEL
In Commercial Distribution

  • 07290015461207 ()
SET000932

  • Therapeutic oncological/gynaecological ultrasound system

NEURO TREATMENT ACCESSORIES KIT - 07290015461191

single use kit for neuro MR-guided FUS treatment contains: Description Cat. No. SILICON SEALANT (GREASE) BUY000180-AA CLEAR SILICONE CAPS MPR001164
INSIGHTEC LTD
NEURO TREATMENT ACCESSORIES KIT
In Commercial Distribution

  • 07290015461191 ()
SET400187

  • Therapeutic oncological/gynaecological ultrasound system

Neuro Head coil - 07290015461184

single use RF head coil for MRI imaging during neuro MRI-guided FUS treatment. a part of 1.5T neuro kit for USA (SET000937)
INSIGHTEC LTD
Neuro Head coil
In Commercial Distribution

  • 07290015461184 ()
ASC002258-AA

  • Therapeutic oncological/gynaecological ultrasound system

Neuro membrane - 07290015461177

neuro membrane for a FUS brain treatment to hold degassed water between transducer and skull. included in 3T Neuro kit for USA (SET000936)
INSIGHTEC LTD
neuro membrane
In Commercial Distribution

  • 07290015461177 ()
ASM000355

  • Therapeutic oncological/gynaecological ultrasound system

neuro cleaning kit for USA - 07290015461160

single use kit for cleaning the product after a neuro clinical treatment
INSIGHTEC LTD
neuro cleaning kit for USA
In Commercial Distribution

  • 07290015461160 ()
SET000933

  • Therapeutic oncological/gynaecological ultrasound system

Neuro Kit 1.5T for USA - 07290015461146

Kit for single use during a Neuro treatment guided under 1.5T MRI guidance. Kit content: Part Description ASC002258-AA BRAIN COIL 1.5T ASSY MPR000444 HEAD RING SCREWS LONG SET000932 INSIGHTEC NEURO DQA PHANTOM GEL SET SET000933 EXABLATE NEURO CLEANING KIT SET400187 NEURO TREATMENT ACCESSORIES KIT
INSIGHTEC LTD
Neuro Kit 1.5T for USA
In Commercial Distribution

  • 07290015461146 ()
SET000937

  • Therapeutic oncological/gynaecological ultrasound system

Neuro Kit 3T for USA - 07290015461122

Kit for single use during a Neuro treatment guided under 3T MRI guidance. Kit content: Part Description ASM000355 PATIENT MEMBRANE PACKING ASSY MPR000444 HEAD RING SCREWS LONG SET000932 INSIGHTEC NEURO DQA PHANTOM GEL SET SET000933 EXABLATE NEURO CLEANING KIT SET400187 NEURO TREATMENT ACCESSORIES KIT
INSIGHTEC LTD
Neuro Kit 3T for USA
In Commercial Distribution

  • 07290015461122 ()
SET000936

  • Therapeutic oncological/gynaecological ultrasound system
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