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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ExAblate 2100V1 PHASE ARRAY ASSY Pelvic RF Coil for 1.5T MRI imaging during Body FUS treatments. Contains Upper and Lower part: ASM000426-AA - UPPER PELVIC COIL PHASE ARRAY ASSY ASC001361 - LOWER PELVIC COIL PHASE ARRAY ASSY for ExAblate 2100V1
INSIGHTEC LTD
OPT000037 ExAblate 2100V1 Pelvic RF Coil for Body
In Commercial Distribution

  • 07290015461474 ()
OPT000037

  • Therapeutic oncological/gynaecological ultrasound system
ExAblate 2100V1 LOWER PELVIC COIL for 1.5T GE ARTIST MR guided FUS Body (uterine fibroids, bone mets) treatments
INSIGHTEC LTD
ASC001361-AR ExAblate 2100V1 LOWER PELVIC COIL ASSEMBLY ARTIST
In Commercial Distribution

  • 07290015461467 ()
ASC001361-AR

  • Therapeutic oncological/gynaecological ultrasound system
ExAblate 2100V1 LOWER PELVIC RF COIL for 1.5T MR guided FUS Body (Uterine fibroids, bone mets) treatments
INSIGHTEC LTD
ASC001361 ExAblate 2100V1 LOWER PELVIC COIL
In Commercial Distribution

  • 07290015461450 ()
ASC001361

  • Therapeutic oncological/gynaecological ultrasound system
Single use kit for cleaning the product after a Neuro V2 clinical treatment
INSIGHTEC LTD
SET000961 Neuro V2 cleaning kit
In Commercial Distribution

  • 07290015461443 ()
SET000961

  • Therapeutic oncological/gynaecological ultrasound system
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
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
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
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
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
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
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