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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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Auragen™ - 10381780036111

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU12D5L25
Not in Commercial Distribution

  • M272AU12D5L251 ()
  • 10381780036111 ()

  • 12 platinum contacts


  • Depth electrode

Integra® - 10381780034766

The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cortical electrical activity specifically at the undersurface of the temporal lobe. It has one platinum contact and is supplied with an insertion needle.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
40M08
Not in Commercial Distribution

  • M27240M081 ()
  • 10381780034766 ()

  • Insertion needle 64mm Length


  • Depth electrode

Integra® - 10381780037088

The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cortical electrical activity specifically at the undersurface of the temporal lobe. It has one platinum contact and is supplied with an insertion needle.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
EDSEP
Not in Commercial Distribution

  • M272EDSEP1 ()
  • 10381780037088 ()


  • Depth electrode

Auragen™ - 10381780036326

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU4D5L25
Not in Commercial Distribution

  • M272AU4D5L251 ()
  • 10381780036326 ()

  • 4 platinum contacts


  • Depth electrode

Auragen™ - 10381780036319

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU4D10L5
Not in Commercial Distribution

  • M272AU4D10L51 ()
  • 10381780036319 ()

  • 4 platinum contacts


  • Depth electrode

Auragen™ - 10381780036302

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU4D10L25
Not in Commercial Distribution

  • M272AU4D10L251 ()
  • 10381780036302 ()

  • 4 platinum contacts


  • Depth electrode

Auragen™ - 10381780036104

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU10D5L25
Not in Commercial Distribution

  • M272AU10D5L251 ()
  • 10381780036104 ()

  • 10 platinum contacts


  • Depth electrode

EVO sEEG Electrode - 00856895008627

54.5mm x 16 contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG5516-RF
In Commercial Distribution

  • 00856895008627 ()


  • Depth electrode
  • Percutaneous radio-frequency ablation probe, brain-ablation

EVO sEEG Electrode - 00856895008610

47.5mm x 14 Contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG4814-RF
In Commercial Distribution

  • 00856895008610 ()


  • Depth electrode
  • Percutaneous radio-frequency ablation probe, brain-ablation

EVO sEEG Electrode - 00856895008603

40.5mm x 12 Contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG4112-RF
In Commercial Distribution

  • 00856895008603 ()


  • Depth electrode
  • Percutaneous radio-frequency ablation probe, brain-ablation

EVO sEEG Electrode - 00856895008597

33.5mm x 10 Contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG3410-RF
In Commercial Distribution

  • 00856895008597 ()


  • Depth electrode
  • Percutaneous radio-frequency ablation probe, brain-ablation

EVO sEEG Electrode - 00856895008580

26.5mm x 8 Contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG2708-RF
In Commercial Distribution

  • 00856895008580 ()


  • Percutaneous radio-frequency ablation probe, brain-ablation
  • Depth electrode

EVO sEEG Electrode - 00856895008573

16mm x 5 Contact sEEG Electrode - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG1605-RF
In Commercial Distribution

  • 00856895008573 ()


  • Depth electrode
  • Percutaneous radio-frequency ablation probe, brain-ablation

EVO Cable Assembly - 00856895008375

EVO Cable Assembly Only
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
EVO Cable Assembly
In Commercial Distribution

  • 00856895008375 ()
NEC1602

  • Cortical electrode
  • Depth electrode

EVO sEEG Electrode - 00856895008351

NeuroOne 35mm Anchor Bolt
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
35mm Anchor Bolt
In Commercial Distribution

  • 00856895008351 ()
NSEEG0035

  • Depth electrode

EVO sEEG Electrode - 00856895008344

NeuroOne 30mm Anchor Bolt
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
30mm Anchor Bolt
In Commercial Distribution

  • 00856895008344 ()
NSEEG0030

  • Depth electrode

EVO sEEG Electrode - 00856895008337

NeuroOne 25mm Anchor Bolt
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
25mm Anchor Bolt
In Commercial Distribution

  • 00856895008337 ()
NSEEG0025

  • Depth electrode

EVO sEEG Electrode - 00856895008320

NeuroOne 20mm Anchor Bolt
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
20mm Anchor Bolt
In Commercial Distribution

  • 00856895008320 ()
NSEEG0020

  • Depth electrode

EVO sEEG Electrode - 00856895008313

80mm x 16 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
80mm x 16 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008313 ()
NSEEG8016

  • Depth electrode

EVO sEEG Electrode - 00856895008306

68.5mm x 16 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
68.5mm x 16 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008306 ()
NSEEG6916

  • Depth electrode

EVO sEEG Electrode - 00856895008290

61.5mm x 16 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
61.5mm x 16 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008290 ()
NSEEG6216

  • Depth electrode

EVO sEEG Electrode - 00856895008283

54.5mm x 16 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
54.5mm x 16 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008283 ()
NSEEG5516

  • Depth electrode

EVO sEEG Electrode - 00856895008276

47.5mm x 14 Contact sEEG Electrode kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
47.5mm x 14 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008276 ()
NSEEG4814

  • Depth electrode

EVO sEEG Electrode - 00856895008269

40.5mm x 12 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
40.5mm x 12 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008269 ()
NSEEG4112

  • Depth electrode

EVO sEEG Electrode - 00856895008252

33.5mm x 10 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
33.5mm x 10 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008252 ()
NSEEG3410

  • Depth electrode

EVO sEEG Electrode - 00856895008245

26.5mm x 8 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
26.5mm x 8 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008245 ()
NSEEG2708

  • Depth electrode

EVO sEEG Electrode - 00856895008238

EVO sEEG Electrode 16mm x 5 Contact Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
16mm x 5 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008238 ()
NSEEG1605

  • Depth electrode

DEPTHALON® - 00650551131496

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL, 36MM SPACING BETWEEN CONTACTS #13 & #14
PMT CORPORATION
2102-16-154-NS
In Commercial Distribution

  • 00650551131496 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 110 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-154-NS

  • Depth electrode

DEPTHALON® - 00650551131489

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL, 21MM SPACING BETWEEN CONTACTS #13 AND #14
PMT CORPORATION
2102-16-153-NS
In Commercial Distribution

  • 00650551131489 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 95 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-153-NS

  • Depth electrode

DEPTHALON® - 00650551131472

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL, 13.98MM SPACING BETWEEN CONTACTS #13 AND #14
PMT CORPORATION
2102-16-152-NS
In Commercial Distribution

  • 00650551131472 ()

  • Main Tube Length 27 Centimeter
  • Spacing 2.43 Millimeter
  • Recording Depth 80 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-152-NS

  • Depth electrode
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