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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™ - 10381780036456

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)
AU6D5L25
Not in Commercial Distribution

  • M272AU6D5L251 ()
  • 10381780036456 ()

  • 6 platinum contacts


  • Depth electrode

Auragen™ - 10381780036449

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)
AU6D10L5
Not in Commercial Distribution

  • M272AU6D10L51 ()
  • 10381780036449 ()

  • 6 platinum contacts


  • Depth electrode

Auragen™ - 10381780036432

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)
AU6D10L25
Not in Commercial Distribution

  • M272AU6D10L251 ()
  • 10381780036432 ()

  • 6 platinum contacts


  • 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™ - 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

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

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

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 - 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 - 00856895008351

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

  • 00856895008351 ()
NSEEG0035

  • 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 - 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

108" SIDE RELEASE WALKING BELT BLUE - 00610570022823

No Description
Bird & Cronin, LLC
08146882
In Commercial Distribution

  • 00610570022823 ()


  • Gait rehabilitation system harness

72" SIDE RELEASE WALKING BELT BLUE - 00610570022618

No Description
Bird & Cronin, LLC
08146722
In Commercial Distribution

  • 00610570022618 ()


  • Gait rehabilitation system harness

60" SIDE RELEASE WALKING BELT BLUE - 00610570022335

No Description
Bird & Cronin, LLC
08146602
In Commercial Distribution

  • 00610570022335 ()


  • Gait rehabilitation system harness

54" SIDE RELEASE BELT ROYAL BLUE - 00610570022236

No Description
Bird & Cronin, LLC
08146542
In Commercial Distribution

  • 00610570022236 ()


  • Gait rehabilitation system harness

45" SIDE RELEASE WALKING BELT BLUE - 00610570021918

No Description
Bird & Cronin, LLC
08146452
In Commercial Distribution

  • 00610570021918 ()


  • Gait rehabilitation system harness

30" TRANSFER BOARD W/HANDLES - 00610570006120

No Description
Bird & Cronin, LLC
08141349
In Commercial Distribution

  • 00610570006120 ()


  • Gait rehabilitation system harness

30" WOOD TRANSFER BOARD - 00610570006113

No Description
Bird & Cronin, LLC
08141340
In Commercial Distribution

  • 00610570006113 ()


  • Gait rehabilitation system harness

24" WOOD TRANSFER BOARD - 00610570006106

No Description
Bird & Cronin, LLC
08141339
In Commercial Distribution

  • 00610570006106 ()


  • Gait rehabilitation system harness

54" WALKING BELT PASTEL STRIPE - 00610570003136

No Description
Bird & Cronin, LLC
08140580
In Commercial Distribution

  • 00610570003136 ()


  • Gait rehabilitation system harness

45" WALKING BELT PASTEL STRIPE - 00610570002801

No Description
Bird & Cronin, LLC
08140480
In Commercial Distribution

  • 00610570002801 ()


  • Gait rehabilitation system harness

MediChoice - 50885632110847

Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle Natural 2 X 72 Inch Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT722
In Commercial Distribution

  • 10885632110849 ()
  • 50885632110847 ()


  • Gait rehabilitation system harness

MediChoice - 50885632110830

Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle Pastel Stripe 2 X 72 Inch Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT721
In Commercial Distribution

  • 10885632110832 ()
  • 50885632110830 ()


  • Gait rehabilitation system harness

MediChoice - 50885632110823

Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle Natural 2 X 60 Inch Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT602
In Commercial Distribution

  • 10885632110825 ()
  • 50885632110823 ()


  • Gait rehabilitation system harness

MediChoice - 50885632110816

Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle Pastel Stripe 2 X 60 Inch Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT601
In Commercial Distribution

  • 10885632110818 ()
  • 50885632110816 ()


  • Gait rehabilitation system harness

MediChoice - 50885632110809

Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle Natural 2 X 54 Inch Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT542
In Commercial Distribution

  • 10885632110801 ()
  • 50885632110809 ()


  • Gait rehabilitation system harness

MediChoice - 50885632110793

Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle Pastel Stripe 2 X 54 Inch Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT541
In Commercial Distribution

  • 10885632110795 ()
  • 50885632110793 ()


  • Gait rehabilitation system harness

108" WALKING BELT BLUE - 00610570187317

No Description
Bird & Cronin, LLC
08141082
In Commercial Distribution

  • 00610570187317 ()
  • 00610570005000 ()


  • Gait rehabilitation system harness

72" WALKING BELT BLUE - 00610570187300

No Description
Bird & Cronin, LLC
08140722
In Commercial Distribution

  • 00610570187300 ()
  • 00610570003785 ()


  • Gait rehabilitation system harness

60" WALKING BELT BLUE - 00610570187294

No Description
Bird & Cronin, LLC
08140602
In Commercial Distribution

  • 00610570187294 ()
  • 00610570003235 ()


  • Gait rehabilitation system harness

54" WALKING BELT BLUE - 00610570187287

No Description
Bird & Cronin, LLC
08140542
In Commercial Distribution

  • 00610570187287 ()
  • 00610570003037 ()


  • Gait rehabilitation system harness

45" WALKING BELT BLUE - 00610570187270

No Description
Bird & Cronin, LLC
08140452
In Commercial Distribution

  • 00610570187270 ()
  • 00610570002603 ()


  • Gait rehabilitation system harness

108" GAIT BELT NATURAL - 00610570163250

No Description
Bird & Cronin, LLC
90000108
In Commercial Distribution

  • 00610570163250 ()


  • Gait rehabilitation system harness

SYNCHROMED ® II - 00613994779229

PUMP 8637-20 SM2 20ML EMAN US JUN BATRY
MEDTRONIC, INC.
8637-20
Not in Commercial Distribution

  • 00613994779229 ()

  • Total Volume: 20.0 Milliliter


  • Implantable intrathecal infusion pump, programmable

72" GAIT BELT NATURAL METAL BUCKLE - 50610570149945

No Description
Bird & Cronin, LLC
08146545
In Commercial Distribution

  • 50610570149945 ()
  • 00610570149940 ()


  • Gait rehabilitation system harness

72" WALKING BELT PASTEL STRIPE - 50610570004046

No Description
Bird & Cronin, LLC
08140780
In Commercial Distribution

  • 50610570004046 ()
  • 00610570004041 ()


  • Gait rehabilitation system harness

60" WALKING BELT PASTEL STRIPE - 50610570003612

No Description
Bird & Cronin, LLC
08140680
In Commercial Distribution

  • 50610570003612 ()
  • 00610570003617 ()


  • Gait rehabilitation system harness

OrthoMedFlex - M7161111818000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 18, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1800
In Commercial Distribution

  • M7161111818000 ()
111-18-1800

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111816000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 16, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1600
In Commercial Distribution

  • M7161111816000 ()
111-18-1600

  • Press-fit femoral stem prosthesis
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