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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No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Microelectrode Holder “X” W/O Screws
In Commercial Distribution

  • 07290114061292 ()
341-000311-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Microelectrode Holder “+” W/O Screws
In Commercial Distribution

  • 07290114061285 ()
341-000312-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Leksell Non-X/Y frame adapter
In Commercial Distribution

  • 07290114061261 ()
341-309011-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Universal LeadConfirm Holder
In Commercial Distribution

  • 07290114061254 ()
700-S01000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Universal Frame Lead Holder - Short
In Commercial Distribution

  • 07290114061247 ()
700-S00422-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Universal Frame Lead Holder - Long
In Commercial Distribution

  • 07290114061230 ()
700-S00420-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Mechanical Accessories Sterilization Tray
In Commercial Distribution

  • 07290114061223 ()
366-000022-22

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Headstage Sterilization Tray
In Commercial Distribution

  • 07290114061216 ()
366-000122-22

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
1
In Commercial Distribution

  • 07290114061209 ()
366-000322-22

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
1
In Commercial Distribution

  • 07290114061193 ()
366-000422-22

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 5
In Commercial Distribution

  • 07290114060967 ()
700-006008-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 4
In Commercial Distribution

  • 07290114060899 ()
750-000027-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 6.0
In Commercial Distribution

  • 07290114060882 ()
750-000025-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type L-5.5mm
In Commercial Distribution

  • 07290114060875 ()
190-000117-11

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type N-4 mm
In Commercial Distribution

  • 07290114060851 ()
190-000117-15

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type K
In Commercial Distribution

  • 07290114060844 ()
190-000117-14

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type D
In Commercial Distribution

  • 07290114060820 ()
190-000117-12

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart NeuroForits Drive Headstage
In Commercial Distribution

  • 07290114060790 ()


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

  • 07290114060561 ()
750-000070-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type H
In Commercial Distribution

  • 07290114060554 ()
190-000117-09

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type F
In Commercial Distribution

  • 07290114060547 ()
190-000117-08

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type I
In Commercial Distribution

  • 07290114060530 ()
190-000117-07

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type M
In Commercial Distribution

  • 07290114060523 ()
190-000117-05

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type L-4mm
In Commercial Distribution

  • 07290114060516 ()
190-000117-04

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type J
In Commercial Distribution

  • 07290114060509 ()
190-000117-03

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type G
In Commercial Distribution

  • 07290114060493 ()
190-000117-02

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type B
In Commercial Distribution

  • 07290114060486 ()
190-000117-01

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Frame adapter thumb screw - Pack of 3
In Commercial Distribution

  • 37290114061408 ()
700-001330-03

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, 2 LOOSE CONNECTORS
PMT CORPORATION
2102-32-09-NS
In Commercial Distribution

  • 10650551092992 ()
  • 00650551092995 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 22 Gauge
  • Recording Length 0.25 Inch
2102-32-09-NS

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
PMT CORPORATION
2102-32-05-NS
In Commercial Distribution

  • 10650551092961 ()
  • 00650551092964 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 22 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-05-NS

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-03-NS
In Commercial Distribution

  • 10650551092954 ()
  • 00650551092957 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2102-32-03-NS

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

  • 10650551092930 ()
  • 00650551092933 ()

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

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

  • 10650551092916 ()
  • 00650551092919 ()

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

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

  • 10650551092893 ()
  • 00650551092896 ()

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

  • Depth electrode
SPHENOIDAL ELECTRODE EEG CABLE 1.5MM SOCKET SET
PMT CORPORATION
2122NS
In Commercial Distribution

  • 10650551092879 ()
  • 00650551092872 ()
2122NS

  • Depth electrode
SPHENOIDAL ELECTRODE EEG CABLE 1.5MM SOCKET SET
PMT CORPORATION
2122
In Commercial Distribution

  • 10650551092862 ()
  • 00650551092865 ()
2122

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, 2 LOOSE CONNECTORS
PMT CORPORATION
2102-32-09
In Commercial Distribution

  • 10650551092855 ()
  • 00650551092858 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 22 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-09

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
PMT CORPORATION
2102-32-05
In Commercial Distribution

  • 10650551092848 ()
  • 00650551092841 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 22 Gauge
  • Recording Length 0.25 Inch
2102-32-05

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-03
In Commercial Distribution

  • 10650551092831 ()
  • 00650551092834 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-03

  • Depth electrode
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
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
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