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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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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
Transmission gel pad for single Body treatment. shipped in the following thickness (height) variants: Description Catalogue Number GEL PAD UF 25MM ASSY ASM000352-AA GEL PAD 15MM ASSY ASM000830-AA GEL PAD 40MM ASSY(Step) ASM002213 GEL PAD 45MM ASSY(Bowl) ASM000504-AA
INSIGHTEC LTD
Gel Pad ASSY
In Commercial Distribution

  • 07290015461085 ()

  • Height: 45 Millimeter
  • Height: 40 Millimeter
  • Height: 25 Millimeter
  • Height: 15 Millimeter
SET999014

  • Therapeutic oncological/gynaecological ultrasound system
water bag kit for ultrasound good transmission in bone treatment
INSIGHTEC LTD
water bag kit
In Commercial Distribution

  • 07290015461054 ()
SET000840

  • Therapeutic oncological/gynaecological ultrasound system
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