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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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nGEN Pump - 10846835017472

Irrigation Pump
Biosense Webster Inc
D139702
In Commercial Distribution

  • 10846835017472 ()
D139702

  • Cardiac radio-frequency ablation system generator

EluNIR-PERL Ridaforolimus Eluting Coronary Stent System - 07290107015219

No Description
MEDINOL LTD.
ELM250R12US
In Commercial Distribution

  • 07290107015219 ()

  • Length: 12 Millimeter
  • Lumen/Inner Diameter: 2.5 Millimeter


  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI (5) NON-CE - 07290019402381

ExAblate 4000 (Neuro) EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI (5) NON-CE The membrane and DQA are for 5 treatment reuse
INSIGHTEC LTD
SET001047 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI (5) NON-CE
In Commercial Distribution

  • 07290019402381 ()
SET001047

  • Therapeutic oncological/gynaecological ultrasound system

EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI (5) NON-CE - 07290019402367

ExAblate 4000 (Neuro) EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI (5) NON-CE The membrane and DQA are for 5 treatment reuse
INSIGHTEC LTD
SET001046 EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI (5) NON-CE
In Commercial Distribution

  • 07290019402367 ()
SET001046

  • Therapeutic oncological/gynaecological ultrasound system

EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE (5) NON-CE - 07290019402343

ExAblate 4000 (Neuro) EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE (5) NON-CE The membrane and DQA are for 5 treatment reuse
INSIGHTEC LTD
SET001045 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE (5) NON-CE
In Commercial Distribution

  • 07290019402343 ()
SET001045

  • Therapeutic oncological/gynaecological ultrasound system

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

EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE (5) NON-CE - 07290019402329

ExAblate 4000 (Neuro) EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE (5) NON-CE The membrane and DQA are for 5 treatment reuse
INSIGHTEC LTD
SET001044 EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE (5) NON-CE
In Commercial Distribution

  • 07290019402329 ()
SET001044

  • Therapeutic oncological/gynaecological ultrasound system

Control Unit Battery - 07350094440194

Battery used in addition to the power cord for the Nevisense to enable use of the Nevisense as a portable device.
Scibase AB
521-0001
In Commercial Distribution

  • 07350094440194 ()
521-0001

  • Neoplasm electrical impedance spectrometer

FemCap - 00863008000126

FemCap™ is indicated for use by women of child-bearing age who desire a barrier device to prevent or postpone pregnancy.
FEMCAP, INC.
30 mm large
In Commercial Distribution

  • 00863008000126 ()

  • 30 mm
70-399-30

  • Contraceptive cervical cap, reusable

FemCap - 00863008000119

FemCap™ is indicated for use by women of child-bearing age who desire a barrier device to prevent or postpone pregnancy.
FEMCAP, INC.
26 mm medium
In Commercial Distribution

  • 00863008000119 ()

  • 26 mm
70-399-26

  • Contraceptive cervical cap, reusable
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