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.
Neuro Omega with AutoClavable Drive Headstage
In Commercial Distribution

  • 27290016450846 ()
NOW-020025-00

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

  • 27290016450839 ()
NOW-020021-00

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

  • 27290016450815 ()
700-021507-03

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NexDrive Electrode Holder - Pack of 2
In Commercial Distribution

  • 27290016450242 ()
700-000316-02

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

  • 27290014954094 ()
700-020874-00

  • Depth electrode
GUIDE FOR Ø 2.45MM ACCESSORIES ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
INSTRUMENT GUIDE
In Commercial Distribution

  • 03664539003917 ()
ACS-789/120R

  • Depth electrode
GUIDE FOR Ø 2.45MM ACCESSORIES ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
INSTRUMENT GUIDE
In Commercial Distribution

  • 03664539003900 ()
ACS-789/82R

  • Depth electrode
MARKING ROD Ø 2.45MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
MARKING ROD
In Commercial Distribution

  • 03664539000862 ()
ACS-740

  • Depth electrode
WRENCH FOR ANCHOR BOLT REMOVAL, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
WRENCH
In Commercial Distribution

  • 03664539000824 ()
ACS-715

  • Depth electrode
SCREWDRIVER FOR STOP, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
FLAT SCREWDRIVER
In Commercial Distribution

  • 03664539000817 ()
ACS-714

  • Depth electrode
BONE STARTER Ø 2.45MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
BONE STARTER
In Commercial Distribution

  • 03664539000800 ()
ACS-745

  • Depth electrode
SCREWDRIVER FOR ANCHOR BOLT PLACEMENT, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
LONG SCREWDRIVER
In Commercial Distribution

  • 03664539000794 ()
ACS-710

  • Depth electrode
SCREWDRIVER FOR ANCHOR BOLT REMOVAL, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
SHORT SCREWDRIVER
In Commercial Distribution

  • 03664539000787 ()
ACS-711

  • Depth electrode
SLIDING RULER FOR Ø 2.45MM ACCESSORIES, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
SLIDING RULER
In Commercial Distribution

  • 03664539000770 ()
ACS-750

  • Depth electrode
RULER FOR Ø 0.8MM ACCESSORIES, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DEPTH REPORT DEVICE
In Commercial Distribution

  • 03664539000718 ()
ACS-751

  • Depth electrode
GUIDE FOR Ø 2.45MM ACCESSORIES, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
INSTRUMENT GUIDE
In Commercial Distribution

  • 03664539000466 ()
ACS-789-ROSA

  • Depth electrode
GUIDE FOR Ø 2.45MM ACCESSORIES, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
INSTRUMENT GUIDE
In Commercial Distribution

  • 03664539000459 ()
ACS-789/120

  • Depth electrode
GUIDE FOR Ø 2.45MM ACCESSORIES, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
INSTRUMENT GUIDE
In Commercial Distribution

  • 03664539000435 ()
ACS-1300

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(BP)(BP8)-00582
In Commercial Distribution

  • 10873263005825 ()
  • 00873263005828 ()

  • Length: 3 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 271.4 Millimeter
  • Length: 263.4 Millimeter
  • Impedance: Megaohms
MTDWBN(BP)(BP8)

  • Depth electrode
microTargeting(TM) Electrode, 6x, non-sterile, D.ZAP(Z), for use with Nexframe(R) and STar Drive
FHC, INC.
5735Z-00581
In Commercial Distribution

  • 10873263005818 ()
  • 00873263005811 ()

  • Outer Diameter: 0.56 Millimeter
  • Length: 242.2 Millimeter
  • Length: 227.2 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
5735Z

  • Depth electrode
microTargeting(TM) Electrode, 6x, non-sterile, D.ZAP(L), for use with Nexframe(R) and STar Drive
FHC, INC.
5735L-00580
In Commercial Distribution

  • 10873263005801 ()
  • 00873263005804 ()

  • Length: 242.2 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 227.2 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
5735L

  • Depth electrode
microTargeting(TM) Electrode, 6x, non-sterile, for use with Nexframe(R) and STar Drive
FHC, INC.
5730R-00579
In Commercial Distribution

  • 10873263005795 ()
  • 00873263005798 ()

  • Outer Diameter: 0.56 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Length: 242.2 Millimeter
  • Length: 227.2 Millimeter
5730R

  • Depth electrode
microTargeting(TM) Electrode, non-sterile, DZAP(Z), for use with Nexframe(R)
FHC, INC.
5035Z-00577
In Commercial Distribution

  • 10873263005771 ()
  • 00873263005774 ()

  • Length: 10 Millimeter
  • Length: 249.2 Millimeter
  • Length: 234.2 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
5035Z

  • Depth electrode
microTargeting(TM) Electrode, non-sterile, DZAP(L), for use with Nexframe(R)
FHC, INC.
5035L-00576
In Commercial Distribution

  • 10873263005764 ()
  • 00873263005767 ()

  • Length: 234.2 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 10 Millimeter
  • Length: 249.2 Millimeter
5035L

  • Depth electrode
microTargeting(TM) Electrode, non-sterile, for use with Nexframe(R)
FHC, INC.
5030R-00575
In Commercial Distribution

  • 10873263005757 ()
  • 00873263005750 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 10 Millimeter
  • Length: 249.2 Millimeter
  • Length: 234.2 Millimeter
5030R

  • Depth electrode
microTargeting(TM) Electrode, 6x, non-sterile, single, D.ZAP(L), for use with Platform
FHC, INC.
44935L-00573
In Commercial Distribution

  • 10873263005733 ()
  • 00873263005736 ()

  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 205.7 Millimeter
  • Length: 220.7 Millimeter
  • Outer Diameter: 0.55 Millimeter
44935L

  • Depth electrode
microTargeting(TM) Electrode, 6x, non-sterile, single, for use with Platform
FHC, INC.
44930R-00572
In Commercial Distribution

  • 10873263005726 ()
  • 00873263005729 ()

  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
  • Length: 220.7 Millimeter
  • Length: 205.7 Millimeter
44930R

  • Depth electrode
microTargeting(TM) Electrode, non-sterile, single, T=30, for use with Frame and STar or MT Drive
FHC, INC.
34620R-00571
In Commercial Distribution

  • 10873263005719 ()
  • 00873263005712 ()

  • Length: 256.4 Millimeter
  • Length: 10 Millimeter
  • Length: 271.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
34620R

  • Depth electrode
microTargeting(TM) Electrode, differential, nonsterile
FHC, INC.
MTDPXN(EP)(BP8)-00570
In Commercial Distribution

  • 10873263005702 ()
  • 00873263005705 ()

  • Length: 271.4 Millimeter
  • Length: 263.4 Millimeter
  • Outer Diameter: 0.86 Millimeter
  • Length: 3 Millimeter
MTDPXN(EP)(BP8)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten ground tip, nonsterile
FHC, INC.
MTDWXN(BS)(OC4)-00557
In Commercial Distribution

  • 10873263005573 ()
  • 00873263005576 ()

  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 1 Millimeter
  • Length: 270.5 Millimeter
MTDWXN(BS)(OC4)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten ground tip, nonsterile
FHC, INC.
MTDWXN(BS)(OC3)-00536
In Commercial Distribution

  • 10873263005368 ()
  • 00873263005361 ()

  • Length: 1 Millimeter
  • Length: 293 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 286 Millimeter
MTDWXN(BS)(OC3)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, D.ZAP(L), nonsterile
FHC, INC.
MTDWLN(BS)(FM2)-00534
In Commercial Distribution

  • 10873263005344 ()
  • 00873263005347 ()

  • Outer Diameter: 0.77 Millimeter
  • Length: 2 Millimeter
  • Length: 93 Millimeter
  • Length: 100 Millimeter
  • Impedance: Megaohms
MTDWLN(BS)(FM2)

  • Depth electrode
microTargeting(TM) Electrode, side by side, tungsten, DZAP(L), nonsterile
FHC, INC.
MTTWLN(ZK2)-00517
In Commercial Distribution

  • 10873263005177 ()
  • 00873263005170 ()

  • Length: 252 Millimeter
  • Impedance: Megaohms
MTTWLN(ZK2)

  • Depth electrode
microTargeting(TM) Electrode, shielded, tungsten, nonsterile, 6x
FHC, INC.
MTSWBN(LX1)-00488
In Commercial Distribution

  • 10873263004880 ()
  • 00873263004883 ()

  • Outer Diameter: 1.24 Millimeter
  • Impedance: Megaohms
  • Length: 50 Millimeter
  • Length: 193 Millimeter
  • Length: 49 Millimeter
  • Length: 246 Millimeter
MTSWBN(LX1)

  • Depth electrode
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