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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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EXABLATE - 07290015461016

System for non-invasive tumor ablation through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS). Customer replaceable patient cradle.
INSIGHTEC LTD
2100 Type 1.0/1.1/1.11
In Commercial Distribution

  • 07290015461016 ()

  • Weight: 890 Kilogram
EXABLATE 2100

  • Therapeutic oncological/gynaecological ultrasound system

NEURO PATIENT TREAT.KITS 3T MASTER SET - 07290015461344

Kit for 5 Neuro treatments performed under 3T MRI guidance. Kit content: Part Description SET000936-AA Neuro kit 3T US MPR000444-AA HEAD RING SCREWS LONG (sterile)
INSIGHTEC LTD
SET000972 NEURO PATIENT TREAT.KITS 3T MASTER SET
In Commercial Distribution

  • 07290015461344 ()
SET000972

  • 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

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

EXABLATE - 07290015461009

System for non-invasive tumor ablation through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS).
INSIGHTEC LTD
2000
In Commercial Distribution

  • 07290015461009 ()

  • Weight: 890 Kilogram
EXABLATE 2000

  • Therapeutic oncological/gynaecological ultrasound system

Omnia - 00813426020596

Patient Remote 3000 Kit
NEVRO CORP.
PTRC3000
In Commercial Distribution

  • 00813426020596 ()
PTRC3000

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer

Omnia - 00813426020541

Patient Remote 2300 Kit
NEVRO CORP.
PTRC2300
In Commercial Distribution

  • 00813426020541 ()
PTRC2300

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer

MyCareLink™ - 00763000367893

MONITOR 24955 FRU USA GOLD
MEDTRONIC, INC.
24955
In Commercial Distribution

  • 00763000367893 ()


  • Cardiac pulse generator reader, home-use
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