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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 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 Protective Frame Pin Cup - 07290015461306

single use silicon cups to protect head membrane from tearing by stereotactic frame sharp screws during FUS neuro clinical treatment
INSIGHTEC LTD
Neuro Protective Frame Pin Cup
In Commercial Distribution

  • 07290015461306 ()
MPR001164

  • 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

Neuro Stereotactic Frame Set - 07290015461283

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

  • 07290015461283 ()
SET400168

  • Therapeutic oncological/gynaecological ultrasound system

HEAD RING SCREWS SHORT - 07290015461276

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

  • 07290015461276 ()
MPR000445

  • Therapeutic oncological/gynaecological ultrasound system

Patient plastic drape - 07290015461269

patient plastic drape to accomodate degassed water and gel pad in a MR-guided FUS treatment. a part of UF/Bone1 treatment kit (SET000016)
INSIGHTEC LTD
Patient plastic drape
In Commercial Distribution

  • 07290015461269 ()
DTP000067

  • Therapeutic oncological/gynaecological ultrasound system

1L degasseed water pouch - 07290015461252

1 liter degassed water pouch for use in UF and Bone1 MR-guided FUS treatment for good ultrasound beam transmission. a part of UF/Bone 1 treatment kit (SET000016)
INSIGHTEC LTD
1L degasseed water pouch
In Commercial Distribution

  • 07290015461252 ()
ASM001480

  • Therapeutic oncological/gynaecological ultrasound system

Neuro Helmet Sealant - 07290015461245

Neuro Helmet Sealant for neuro FUS clinical treatment
INSIGHTEC LTD
Neuro Helmet Sealant
In Commercial Distribution

  • 07290015461245 ()
BUY000180-AA

  • Therapeutic oncological/gynaecological ultrasound system

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
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