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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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microTargeting™ Electrode - 10873263003074

microTargeting(TM) electrode, back loaded, non sterile, specify impedance, platinum/iridium, glass insulated
FHC, INC.
MTBPXN(EN3)-00307
In Commercial Distribution

  • 10873263003074 ()
  • 00873263003077 ()

  • Length: 40 Millimeter
  • Length: 280 Millimeter
  • Outer Diameter: 0.63 Millimeter
MTBPXN(EN3)

  • Depth electrode

microTargeting™ Electrode - 10873263003029

microTargeting(TM) Electrode, back loaded, non sterile, platinum/iridium, glass insulated
FHC, INC.
MTBPBN(KB1)-00302
In Commercial Distribution

  • 10873263003029 ()
  • 00873263003022 ()

  • Length: 30 Millimeter
  • Length: 305 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.63 Millimeter
MTBPBN(KB1)

  • Depth electrode

microTargeting™ Electrode - 10873263002978

microTargeting(TM) Electrode, back loaded, non sterile, Platinum/Iridium, glass insulated
FHC, INC.
MTBPBN(EN2)-00297
In Commercial Distribution

  • 10873263002978 ()
  • 00873263002971 ()

  • Outer Diameter: 0.63 Millimeter
  • Length: 50 Millimeter
  • Length: 300 Millimeter
  • Impedance: Megaohms
MTBPBN(EN2)

  • Depth electrode

microTargeting™ Electrode - 10873263002916

microTargeting(TM) Electrode, Back loaded, Platinum/Iridium with Glass Insulation
FHC, INC.
MTBPBN(AZ1)-00291
In Commercial Distribution

  • 10873263002916 ()
  • 00873263002919 ()

  • Outer Diameter: 0.63 Millimeter
  • Length: 35 Millimeter
  • Impedance: Megaohms
  • Length: 260 Millimeter
MTBPBN(AZ1)

  • Depth electrode

microTargeting™ Electrode - 10873263002565

microTargeting(TM) Electrode, 6x, non-sterile, D.ZAP(Z), Platform
FHC, INC.
44935Z-00256
In Commercial Distribution

  • 10873263002565 ()
  • 00873263002568 ()

  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 220.72 Millimeter
  • Length: 205.72 Millimeter
44935Z

  • Depth electrode

microTargeting™ Electrode - 10873263002497

microTargeting(TM) Electrode, non-sterile, single, D.ZAP(Z) T=30, for use with Frame and STar or MT Drive
FHC, INC.
34625Z-00249
In Commercial Distribution

  • 10873263002497 ()
  • 00873263002490 ()

  • Outer Diameter: 0.77 Millimeter
  • Length: 256.4 Millimeter
  • Length: 271.4 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
34625Z

  • Depth electrode

microTargeting™ Electrode - 10873263002480

microTargeting(TM) Electrode, non-sterile, single, DZAP(L) T=30, for use with Frame and STar or MT Drive
FHC, INC.
34625L-00248
In Commercial Distribution

  • 10873263002480 ()
  • 00873263002483 ()

  • Length: 256.4 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 271.4 Millimeter
  • Impedance: Megaohms
34625L

  • Depth electrode

microTargeting™ Electrode - 10873263002411

microTargeting(TM) Electrode, non sterile, 6x, Array, D.ZAP(Z), T=30 for use with frame, STar or MT Drive
FHC, INC.
22635Z-00241
In Commercial Distribution

  • 10873263002411 ()
  • 00873263002414 ()

  • Impedance: Megaohms
  • Length: 261.5 Millimeter
  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
22635Z

  • Depth electrode

microTargeting™ Electrode - 10873263002404

microTargeting(TM) Electrode, non-sterile, 6x, array, D.ZAP(L), T=30 for use with frame, STar or MT Drive
FHC, INC.
22635L-00240
In Commercial Distribution

  • 10873263002404 ()
  • 00873263002407 ()

  • Impedance: Megaohms
  • Length: 261.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
22635L

  • Depth electrode

microTargeting™ Electrode - 10873263002398

microTargeting(TM) Electrode, 6x, non-sterile, Array, 1 Meg, T=30 for use with frame and STar or mT drive
FHC, INC.
22630R-00239
In Commercial Distribution

  • 10873263002398 ()
  • 00873263002391 ()

  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 261.5 Millimeter
  • Impedance: Megaohms
22630R

  • Depth electrode

microTargeting™ Electrode - 10873263001360

microTargeting Electrode 6x, non-sterile, Array, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC1003-00136
Not in Commercial Distribution

  • 10873263001360 ()
  • 00873263001363 ()

  • Length: 276.5 Millimeter
  • Length: 261.5 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
FC1003

  • Depth electrode

microTargeting™ Electrode - 10873263001353

microTargeting Electrode 6x, non-sterile, Single, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC1002-00135
Not in Commercial Distribution

  • 10873263001353 ()
  • 00873263001356 ()

  • Length: 271.4 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.77 Millimeter
  • Length: 256.4 Millimeter
  • Length: 10 Millimeter
FC1002

  • Depth electrode

microTargeting™ Electrodes - 10873263001292

microTargeting Differential Electrodes 5x, Sterile, Single and Array, DZAP(L), T=30 for use with Nexframe and STar Drive
FHC, INC.
FC2004-00129
Not in Commercial Distribution

  • 10873263001292 ()
  • 00873263001295 ()

  • Length: 227.2 Millimeter
  • Length: 242.2 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 10 Millimeter
FC2004

  • Depth electrode

microTargeting™ Electrode - 10873263001285

microTargeting Differential Electrode 5x, Sterile, Single and Array, D.ZAP(L) , T=30 for use with NexFrame and MT Drive or NexDrive
FHC, INC.
FC2003-00128
Not in Commercial Distribution

  • 10873263001285 ()
  • 00873263001288 ()

  • Length: 249.2 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 234.2 Millimeter
  • Length: 10 Millimeter
FC2003

  • Depth electrode

microTargeting™ Electrode - 10873263001278

microTargeting D.ZAP(L) Differential Electrode 5x, Sterile, Single, T=30 for use with Frame and STar or MT Drive
FHC, INC.
FC2002-00127
Not in Commercial Distribution

  • 10873263001278 ()
  • 00873263001271 ()

  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Length: 271.4 Millimeter
  • Length: 256.4 Millimeter
FC2002

  • Depth electrode

microTargeting™ Electrode - 10873263001261

microTargeting Differential Electrode 5x, D.ZAP(L), Sterile, Array, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC2001-00126
Not in Commercial Distribution

  • 10873263001261 ()
  • 00873263001264 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
  • Length: 261.5 Millimeter
  • Length: 276.5 Millimeter
FC2001

  • Depth electrode

microTargeting™ Electrode - 10873263001254

microTargeting Differential Electrode 5x, Sterile, Single, 1 Meg, T=30 for use with frame, STar or MT Drive
FHC, INC.
34680-00125
Not in Commercial Distribution

  • 10873263001254 ()
  • 00873263001257 ()

  • Impedance: Megaohms
  • Length: 256.4 Millimeter
  • Length: 271.4 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
34680

  • Depth electrode

microTargeting™ Electrode - 10873263001247

microTargeting Differential Electrode 5x, Sterile, Array, 1 Meg, T=30 for use with frame, STar or MT Drive
FHC, INC.
22670-00124
Not in Commercial Distribution

  • 10873263001247 ()
  • 00873263001240 ()

  • Length: 261.5 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
22670

  • Depth electrode

microTargeting™ Electrodes - 10873263001179

microTargeting(TM) Electrodes, 5x, Sterile, Single or Array, 1 Meg, for use with NexFrame and mT Drive or NexDrive.
FHC, INC.
FC5000-00117
Not in Commercial Distribution

  • 10873263001179 ()
  • 00873263001172 ()

  • Length: 249.2 Millimeter
  • Length: 10 Millimeter
  • Length: 234.2 Millimeter
  • Impedance: Megaohms
  • Length: 0.56 Millimeter
FC5000

  • 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

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

Neuro Omega Drive Headstage Kit - 27290114064532

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega Drive Headstage Kit
In Commercial Distribution

  • 27290114064532 ()
750-020021-00

  • Depth electrode

Neuro Omega with Neuro Omega Drive Headstage - 27290114064525

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage
In Commercial Distribution

  • 27290114064525 ()
NOW-020021-00

  • Depth electrode

Neuro Omega with Neuro Omega Drive Headstage + 2 basic stimulation Slots - 27290114064518

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage + 2 basic stimulation Slots
In Commercial Distribution

  • 27290114064518 ()
NOW-DFF000-00

  • Depth electrode

Neuro Omega with Neuro Omega Drive Headstage + 1 basic stimulation Slot - 27290114064501

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage + 1 basic stimulation Slot
In Commercial Distribution

  • 27290114064501 ()
NOW-DF0000-00

  • Depth electrode

NeuroNav Drive Headstage - 27290114064488

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav Drive Headstage
In Commercial Distribution

  • 27290114064488 ()
NNW-026000-55

  • Depth electrode

Leibinger RM frame Mechanical Set KIT - 27290114064112

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Long Bengun
In Commercial Distribution

  • 27290114064112 ()
700-020874-00

  • Depth electrode

Leksell Non-XY frame Mechanical Set KIT - 27290114064099

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Long Bengun
In Commercial Distribution

  • 27290114064099 ()
700-020832-00

  • Depth electrode

Renishaw Non-XY frame Mechanical Set KIT - 27290114064044

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Renishaw Non-XY frame Mechanical Set KIT
In Commercial Distribution

  • 27290114064044 ()
700-020050-00

  • Depth electrode

Neuro Omega with Neuro Omega Drive Headstage - 27290114063856

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage
In Commercial Distribution

  • 27290114063856 ()
NOW-020021-00

  • Depth electrode

NeuroSmart with AutoClavable Drive Headstage (AutoClavable) - 27290114063306

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart with AutoClavable Drive Headstage (AutoClavable)
In Commercial Distribution

  • 27290114063306 ()
NSW-006008-55

  • Depth electrode

NeuroNav with MER Headstage - 27290114063276

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav with MER Headstage
In Commercial Distribution

  • 27290114063276 ()
NNW-025023-55

  • Depth electrode

Neuro Omega with NeuroFortis Drive Headstage + 1 basic stimulation Slot - 27290114063160

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with NeuroFortis Drive Headstage + 1 basic stimulation Slot
In Commercial Distribution

  • 27290114063160 ()
NOW-NF0000-00

  • Depth electrode

NeuroSmart Autoclavable Drive Headstage KIT (Autoclavable) - 27290114063153

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart Autoclavable Drive Headstage KIT (Autoclavable)
In Commercial Distribution

  • 27290114063153 ()
700-026008-00

  • Depth electrode

NeuroSmart MER Headstage KIT - 27290114063146

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart MER Headstage KIT
In Commercial Distribution

  • 27290114063146 ()
700-026009-00

  • Depth electrode

NeuroFortis NeuroSmart Drive Headstage KIT - 27290114063139

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroFortis NeuroSmart Drive Headstage KIT
In Commercial Distribution

  • 27290114063139 ()
700-026010-00

  • Depth electrode

NeuroSmart with NeuroFortis Drive Headstage - 27290114063016

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart with NeuroFortis Drive Headstage
In Commercial Distribution

  • 27290114063016 ()
NSW-026010-55

  • Depth electrode
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