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 Array Electrode, 1x, sterile, D.ZAP(L) for use with Frame, STar or MT Drive
FHC, INC.
22675L-00244
In Commercial Distribution

  • 10873263002442 ()
  • 00873263002445 ()

  • Impedance: Megaohms
  • Length: 261.5 Millimeter
  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
22675L

  • Depth electrode
microTargeting Array Electrode, sterile, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
22670R-00242
In Commercial Distribution

  • 10873263002428 ()
  • 00873263002421 ()

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

  • Depth electrode
microTargeting Electrode Cable, Sterile, for use with microTargeting Electrodes
FHC, INC.
66-EL-EC-00155
In Commercial Distribution

  • 00873263001554 ()
66-EL-EC

  • Depth electrode
microTargeting Electrode Cable
FHC, INC.
FC1020-00151
In Commercial Distribution

  • 00873263001516 ()
FC1020

  • Depth electrode
microTargeting Electrode Cable
FHC, INC.
FC1020-00139
In Commercial Distribution

  • 00873263001394 ()
FC1020

  • 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)
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)
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)
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 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
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-023
In Commercial Distribution

  • 09348215055783 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1804
In Commercial Distribution

  • 09348215092825 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1604
In Commercial Distribution

  • 09348215092818 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1504
In Commercial Distribution

  • 09348215092801 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1404
In Commercial Distribution

  • 09348215092795 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1304
In Commercial Distribution

  • 09348215092788 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1204
In Commercial Distribution

  • 09348215092771 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1104
In Commercial Distribution

  • 09348215092764 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1004
In Commercial Distribution

  • 09348215092757 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0904
In Commercial Distribution

  • 09348215092740 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-027
In Commercial Distribution

  • 09348215081423 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1813
In Commercial Distribution

  • 09348215088569 ()


  • Coated femoral stem prosthesis, modular
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