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.
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.
NeuroSmart with AutoClavable Drive Headstage
In Commercial Distribution

  • 27290016450099 ()
NSW-006008-55

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

  • 27290016450082 ()
NSW-026010-55

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

  • 27290016450068 ()
NNW-006008-55

  • 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
SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS, EXPLORATION LENGTH 50, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO-MACRO ELECTRODE
In Commercial Distribution

  • 03664539003450 ()

  • "Macro Contact Length 2 Millimeters Macro Contact Spacing 2 Millimeters Micro Contact Exposure Diameter 0,02 Millimeters"
MM08-06B51D12

  • Depth electrode
SEEG DEPTH ELECTRODE, 9 MACRO AND 8 MICRO-CONTACTS, EXPLORATION LENGTH 40,4, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO-MACRO ELECTRODE
In Commercial Distribution

  • 03664539003443 ()

  • "Macro Contact Length 2 Millimeters Macro Contact Spacing 2,8 Millimeters Micro Contact Exposure Diameter 0,02 Millimeters"
MM08-09A40D08

  • Depth electrode
SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS, EXPLORATION LENGTH 42, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO-MACRO ELECTRODE
In Commercial Distribution

  • 03664539003436 ()

  • "Macro Contact Length 2 Millimeters Macro Contact Spacing 2 Millimeters Micro Contact Exposure Diameter 0,02 Millimeters"
MM08-06B40D12

  • Depth electrode
SEEG DEPTH ELECTRODE, 9 MACRO AND 8 MICRO-CONTACTS, EXPLORATION LENGTH 33,2, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO-MACRO ELECTRODE
In Commercial Distribution

  • 03664539003429 ()

  • "Macro Contact Length 2 Millimeters Macro Contact Spacing 1,9 Millimeters Micro Contact Exposure Diameter 0,02 Millimeters"
MM08-09A33D08

  • Depth electrode
COAGULATION ELECTRODE FOR SCALP, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
COAGULATION ELECTRODE AND STOP
In Commercial Distribution

  • 03664539002927 ()
KIP-ACS-605

  • Depth electrode
TWIST DRILL FOR ANCHOR BOLT, HEXAGONAL SHANK, LENGTH 160MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
Not in Commercial Distribution

  • 03664539002811 ()
KIP-ACS-519

  • Depth electrode
TWIST DRILL FOR ANCHOR BOLT, QUICK LOCKING SHANK, LENGTH 192MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
Not in Commercial Distribution

  • 03664539002798 ()
KIP-ACS-517

  • Depth electrode
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