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.
NeuroSmart Autoclavable Drive Headstage Kit
In Commercial Distribution

  • 27290016450228 ()
700-026008-00

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

  • 27290016450211 ()
750-020025-00

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

  • 27290016450198 ()
750-020021-00

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

  • 27290016450174 ()
700-026000-00

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

  • 27290016450167 ()
750-020024-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart MER HeadStage Kit
In Commercial Distribution

  • 27290016450150 ()
700-026009-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav MER HeadStage KIT
In Commercial Distribution

  • 27290016450143 ()
700-025023-00

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

  • 27290016450136 ()
750-020070-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroFortis NeuroSmart Drive HeadStage KIT
In Commercial Distribution

  • 27290016450129 ()
700-026010-00

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

  • 27290016450105 ()
NOW-020070-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav with NeuroNav Drive
In Commercial Distribution

  • 27290016450051 ()
NNW-026000-55

  • Depth electrode
NeuroNav system with NeuroFortis Drive : NeurFortis Drive requires sterilization before use.
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav with NeuroFortis Drive
In Commercial Distribution

  • 27290016450044 ()
NNW-006010-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Starfix frame Mechanical Set KIT
In Commercial Distribution

  • 27290014954100 ()
700-021508-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
insertion tube Array electrode
In Commercial Distribution

  • 07290016450828 ()
  • 17290016450825 ()
366-70ITAR-00

  • Intracerebral cannula, implantable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Insertion Tube Set 15mm above
In Commercial Distribution

  • 07290016450804 ()
  • 17290016450801 ()
366-66IT07-00

  • Intracerebral cannula, implantable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Insertion Tube Set 20mm above
In Commercial Distribution

  • 07290016450798 ()
  • 17290016450795 ()
366-66IT05-00

  • Intracerebral cannula, implantable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Insertion Tube Set 40mm above
In Commercial Distribution

  • 07290016450781 ()
  • 17290016450788 ()
366-66IT01-00

  • Intracerebral cannula, implantable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Lead Insertion Tube
In Commercial Distribution

  • 07290016450774 ()
  • 17290016450771 ()
366-66IT19-00

  • Intracerebral cannula, implantable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Extractor
In Commercial Distribution

  • 07290016450767 ()
  • 17290016450764 ()
366-70CNET-00

  • Intracerebral cannula, implantable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Stylet without Cannula
In Commercial Distribution

  • 07290016450750 ()
  • 17290016450757 ()
366-000237-00

  • Intracerebral cannula, implantable
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