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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PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
PMT CORPORATION
2102-31-03
In Commercial Distribution

  • 10650551092824 ()
  • 00650551092827 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2102-31-03

  • Depth electrode
STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2101-32-03
In Commercial Distribution

  • 10650551092817 ()
  • 00650551092810 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2101-32-03

  • Depth electrode
STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
PMT CORPORATION
2101-31-03
In Commercial Distribution

  • 10650551092800 ()
  • 00650551092803 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2101-31-03

  • Depth electrode
Walking Harness - XXLarge - Orange Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSXXX
In Commercial Distribution

  • 00817956023126 ()

  • Height: 21 Inch
  • Width: 16 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
Walking Harness - XLarge - Blue Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSXX
In Commercial Distribution

  • 00817956023119 ()

  • Height: 21 Inch
  • Width: 16 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
Walking Harness - Large - Green Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSX
In Commercial Distribution

  • 00817956023102 ()

  • Height: 21 Inch
  • Width: 16 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
Walking Harness - Medium - Yellow Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WS
In Commercial Distribution

  • 00817956023096 ()

  • Height: 21 Inch
  • Width: 17 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
Walking Harness - Small - Red Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSP
In Commercial Distribution

  • 00817956023089 ()

  • Height: 21 Inch
  • Width: 17 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
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)
AU8D5L25
Not in Commercial Distribution

  • M272AU8D5L251 ()
  • 10381780036531 ()

  • 8 platinum contacts


  • Depth electrode
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)
AU8D10L5
Not in Commercial Distribution

  • M272AU8D10L51 ()
  • 10381780036524 ()

  • 8 platinum contacts


  • Depth electrode
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)
AU8D10L25
Not in Commercial Distribution

  • M272AU8D10L251 ()
  • 10381780036517 ()

  • 8 platinum contacts


  • Depth electrode
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
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
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
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
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
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
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
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
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
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
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega MER Headstage
In Commercial Distribution

  • 07290014954991 ()
750-000023-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroProbe
In Commercial Distribution

  • 17290014954974 ()
  • 07290014954977 ()
STR-94685Z-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroProbe
In Commercial Distribution

  • 17290014954967 ()
  • 07290014954960 ()
STR-94685L-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Sterile Neuro Omega AlphaProbe electrode's cable 10 CH
In Commercial Distribution

  • 17290014954950 ()
  • 07290014954953 ()
STR-000664-21

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroProbe
In Commercial Distribution

  • 17290014954943 ()
  • 07290014954946 ()
STR-AP9080-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 17290014954882 ()
  • 07290014954885 ()
366-222291-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 17290014954875 ()
  • 07290014954878 ()
STR-050925-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-Shielded
In Commercial Distribution

  • 17290014954868 ()
  • 07290014954861 ()
STR-000136-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 17290014954851 ()
  • 07290014954854 ()
366-000426-00

  • Depth electrode
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