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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 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
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
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 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
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
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
single use kit for neuro MR-guided FUS treatment contains: Description Cat. No. SILICON SEALANT (GREASE) BUY000180-AA CLEAR SILICONE CAPS MPR001164
INSIGHTEC LTD
NEURO TREATMENT ACCESSORIES KIT
In Commercial Distribution

  • 07290015461191 ()
SET400187

  • Therapeutic oncological/gynaecological ultrasound system
single use RF head coil for MRI imaging during neuro MRI-guided FUS treatment. a part of 1.5T neuro kit for USA (SET000937)
INSIGHTEC LTD
Neuro Head coil
In Commercial Distribution

  • 07290015461184 ()
ASC002258-AA

  • Therapeutic oncological/gynaecological ultrasound system
neuro membrane for a FUS brain treatment to hold degassed water between transducer and skull. included in 3T Neuro kit for USA (SET000936)
INSIGHTEC LTD
neuro membrane
In Commercial Distribution

  • 07290015461177 ()
ASM000355

  • Therapeutic oncological/gynaecological ultrasound system
HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI). Multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment. These are the upgrade kits for Integra headframes to allow compatibility with Insightec-made PFK
INSIGHTEC LTD
SET400168-AE PFK TYPE 1.1 FDA/ROW INTEGRA (FMI)
In Commercial Distribution

  • 07290019402466 ()
SET400168-AE

  • Therapeutic oncological/gynaecological ultrasound system
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