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
In Commercial Distribution

  • 27290114064488 ()
NNW-026000-55

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

  • 27290114064112 ()
700-020874-00

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

  • 27290114064105 ()
700-020847-00

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

  • 27290114064099 ()
700-020832-00

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

  • 27290114064082 ()
700-020834-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Renishaw Non-XY frame Mechanical Set KIT
In Commercial Distribution

  • 27290114064044 ()
700-020050-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with AutoClavable Drive Headstage (AutoClavable)
In Commercial Distribution

  • 27290114063863 ()
NOW-020025-00

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

  • 27290114063856 ()
NOW-020021-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart with AutoClavable Drive Headstage (AutoClavable)
In Commercial Distribution

  • 27290114063306 ()
NSW-006008-55

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

  • 27290114063276 ()
NNW-025023-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega ECOG HeadBox Kit
In Commercial Distribution

  • 27290114063207 ()
750-020016-00

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

  • 27290114061166 ()
700-000316-02

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2
In Commercial Distribution

  • 27290114061159 ()
700-021507-03

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2
In Commercial Distribution

  • 27290114061142 ()
700-021508-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2
In Commercial Distribution

  • 27290114061135 ()
700-020874-00

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

  • 27290114061128 ()
700-020847-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2
In Commercial Distribution

  • 27290114061111 ()
700-020832-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2
In Commercial Distribution

  • 27290114061104 ()
700-020834-00

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

  • 27290114060930 ()
700-026008-00

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

  • 27290114060916 ()
NSW-006008-55

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

  • 27290114060909 ()
NNW-006008-55

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

  • 27290114060879 ()
NNW-025023-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Leksell Non-XY frame Mechanical Set KIT
In Commercial Distribution

  • 27290016450976 ()
700-020832-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega ECoG Recording Kit
In Commercial Distribution

  • 27290016450877 ()
750-02A016-00

  • 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.
Neuro Omega Autoclavable Drive Headstage KIT
In Commercial Distribution

  • 27290016450211 ()
750-020025-00

  • 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.
NeuroSmart MER HeadStage Kit
In Commercial Distribution

  • 27290016450150 ()
700-026009-00

  • 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
microTargeting™ Electrode, tungsten, non sterile, 6x, D.ZAP(Z)
FHC, INC.
MTDWZN(AR)(MP7)-00920
In Commercial Distribution

  • 00873263009208 ()
  • 10873263009205 ()
MTDWZN(AR)(MP7)

  • Depth electrode
microTargeting™ Electrode, differential, tungsten, 6x,D.ZAP(L), nonsterile
FHC, INC.
MTDWLN(BP)(BP6)-00868
In Commercial Distribution

  • 00873263008683 ()
  • 10873263008680 ()
MTDWLN(BP)(BP6)

  • Depth electrode
microTargeting™ Electrode, non sterile, 6x, Array, D.ZAP(Z), T=30 for use with frame, STar or MT Drive
FHC, INC.
MTDWZN(AR)(AR7)-00863
In Commercial Distribution

  • 00873263008638 ()
  • 10873263008635 ()
MTDWZN(AR)(AR7)

  • Depth electrode
microTargeting™ Platform Platinum 6X Non Sterile
FHC, INC.
45335Z-00799
In Commercial Distribution

  • 10873263007997 ()
  • 00873263007990 ()

  • Length: 212.72 Millimeter
  • Impedance: Megaohms
  • Length: 3 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 220.72 Millimeter
45335Z

  • Depth electrode
microTargeting™ Platform 6X Non Sterile
FHC, INC.
44335Z-00797
In Commercial Distribution

  • 10873263007973 ()
  • 00873263007976 ()

  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
  • Length: 212.72 Millimeter
  • Length: 220.72 Millimeter
  • Length: 3 Millimeter
44335Z

  • Depth electrode
microTargeting™ Single Frame Platinum 6x Non Sterile
FHC, INC.
35325Z-00795
In Commercial Distribution

  • 10873263007959 ()
  • 00873263007952 ()

  • Outer Diameter: 0.86 Millimeter
  • Length: 271.4 Millimeter
  • Length: 263.4 Millimeter
  • Length: 3 Millimeter
  • Impedance: Megaohms
35325Z

  • Depth electrode
microTargeting™ Frame Single Tungsten 6X Non Sterile
FHC, INC.
34325Z-00793
In Commercial Distribution

  • 10873263007935 ()
  • 00873263007938 ()

  • Length: 263.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 3 Millimeter
  • Length: 271.4 Millimeter
  • Impedance: Megaohms
34325Z

  • Depth electrode
microTargeting™ Array Frame Platinum 6X Non Sterile
FHC, INC.
25335Z-00791
In Commercial Distribution

  • 10873263007911 ()
  • 00873263007914 ()

  • Outer Diameter: 0.56 Millimeter
  • Length: 276.5 Millimeter
  • Length: 3 Millimeter
  • Length: 268.5 Millimeter
  • Impedance: Megaohms
25335Z

  • Depth electrode
microTargeting™ Array Electrodes 6x Non Sterile
FHC, INC.
22335Z-00789
In Commercial Distribution

  • 10873263007898 ()
  • 00873263007891 ()

  • Length: 3 Millimeter
  • Length: 276.5 Millimeter
  • Length: 268.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
22335Z

  • Depth electrode
microTargeting(TM) Electrodes, 5x, Sterile, Single or Array, 1 Meg, for use with NexFrame and mT Drive or NexDrive.
FHC, INC.
FC5000-00755
In Commercial Distribution

  • 10873263007553 ()
  • 00873263007556 ()

  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 0.56 Millimeter
  • Length: 234.2 Millimeter
  • Length: 249.2 Millimeter
FC5000

  • Depth electrode
microTargeting Differential Electrodes 5x, Sterile, Single and Array, DZAP(L), T=30 for use with Nexframe and STar Drive
FHC, INC.
FC2004-00752
In Commercial Distribution

  • 10873263007522 ()
  • 00873263007525 ()

  • Length: 227.2 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 242.2 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
FC2004

  • Depth electrode
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