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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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A Kit for 5 Neuro treatment used under 1.5T MRI guidance. Kit content: Part Description SET000937-AA Neuro kit 1.5T US MPR000444-AA HEAD RING SCREWS LONG SET (sterile)
INSIGHTEC LTD
SET000973 NEURO PATIENT TREAT.KITS 1.5T MASTER SET
In Commercial Distribution

  • 07290015461351 ()
SET000973

  • Therapeutic oncological/gynaecological ultrasound system
Kit for 5 Neuro treatments performed under 3T MRI guidance. Kit content: Part Description SET000936-AA Neuro kit 3T US MPR000444-AA HEAD RING SCREWS LONG (sterile)
INSIGHTEC LTD
SET000972 NEURO PATIENT TREAT.KITS 3T MASTER SET
In Commercial Distribution

  • 07290015461344 ()
SET000972

  • Therapeutic oncological/gynaecological ultrasound system
strap used for attaching the stereotactic frame to patient head during neuro FUS clinical treatment
INSIGHTEC LTD
Neuro Frame Attachment Strap
In Commercial Distribution

  • 07290015461337 ()
MEC001647

  • Therapeutic oncological/gynaecological ultrasound system
Neuro Helmet Sealant for neuro FUS clinical treatment
INSIGHTEC LTD
Neuro Helmet Sealant
In Commercial Distribution

  • 07290015461245 ()
BUY000180-AA

  • Therapeutic oncological/gynaecological ultrasound system
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
Tissue mimic phantom gel for DQA for Body applications
INSIGHTEC LTD
DQA phantom Body
In Commercial Distribution

  • 07290015461214 ()
SET000885

  • Therapeutic oncological/gynaecological ultrasound system
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
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
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
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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