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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 V2 Kit 3T for USA - 07290015461429

Kit for single use during a Neuro V2 treatment guided under 3T MRI guidance. Kit content: Part Description ASM000355 PATIENT MEMBRANE PACKING ASSY SET000932 INSIGHTEC NEURO DQA PHANTOM GEL SET SET000961 EXABLATE NEURO CLEANING KIT SET400189-AA NEURO TREATMENT ACCESSORIES KIT
INSIGHTEC LTD
SET000960-AA Neuro V2 Kit 3T for USA
In Commercial Distribution

  • 07290015461429 ()
SET000960-AA

  • Therapeutic oncological/gynaecological ultrasound system

NEURO V2 PATIENT TREAT.KITS 3T MASTER SET - 07290015461405

Kit for 5 Neuro V2 treatments performed under 3T MRI guidance. Kit content: Part Description SET000960-AA Neuro V2 kit 3T US MPR000444-AA HEAD RING SCREWS LONG (sterile)
INSIGHTEC LTD
SET000969 NEURO V2 PATIENT TREAT.KITS 3T MASTER SET
In Commercial Distribution

  • 07290015461405 ()
SET000969

  • Therapeutic oncological/gynaecological ultrasound system

Neuro Kit 1.5T for USA - 07290015461399

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 SET000932 INSIGHTEC NEURO DQA PHANTOM GEL SET SET400187 NEURO TREATMENT ACCESSORIES KIT
INSIGHTEC LTD
SET000937-AA Neuro Kit 1.5T for USA
In Commercial Distribution

  • 07290015461399 ()
SET000937-AA

  • Therapeutic oncological/gynaecological ultrasound system

Neuro Kit 3T for USA - 07290015461382

Kit for single use during a Neuro treatment guided under 3T MRI guidance. Kit content: Part Description ASM000355 PATIENT MEMBRANE PACKING ASSY SET000932 INSIGHTEC NEURO DQA PHANTOM GEL SET SET400187 NEURO TREATMENT ACCESSORIES KIT
INSIGHTEC LTD
SET000936-AA Neuro Kit 3T for USA
In Commercial Distribution

  • 07290015461382 ()
SET000936-AA

  • Therapeutic oncological/gynaecological ultrasound system

HEAD RING SCREWS SHORT - 07290015461375

Short single use short screws connecting stereotactic frame with patient skull during neuro MRI guided FUS treatment.
INSIGHTEC LTD
MPR000445-AA HEAD RING SCREWS SHORT
In Commercial Distribution

  • 07290015461375 ()
MPR000445-AA

  • Therapeutic oncological/gynaecological ultrasound system

HEAD RING SCREWS LONG - 07290015461368

Single use screws connecting stereotactic frame with patient skull during neuro MRI guided FUS treatment.
INSIGHTEC LTD
MPR000444-AA HEAD RING SCREWS LONG SET
In Commercial Distribution

  • 07290015461368 ()
MPR000444-AA

  • Therapeutic oncological/gynaecological ultrasound system

NEURO PATIENT TREAT.KITS 1.5T MASTER SET for USA - 07290015461351

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

Neuro Frame Attachment Strap - 07290015461337

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 Stereotactic Frame Screws Set - 07290015461313

spare screws for neuro stereotactic frame for use during neuro FUS clinical treatment
INSIGHTEC LTD
Neuro Stereotactic Frame Screws Set
In Commercial Distribution

  • 07290015461313 ()
MPR001138

  • Therapeutic oncological/gynaecological ultrasound system

Neuro Stereotactic Frame - 07290015461290

a multi use ASM001399 for fixing the skull position during neuro FUS clinical treatment
INSIGHTEC LTD
Neuro Stereotactic Frame
In Commercial Distribution

  • 07290015461290 ()
ASM001399

  • Therapeutic oncological/gynaecological ultrasound system
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