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.
Bengun Adapter
In Commercial Distribution

  • 07290114064156 ()
352-000212-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Bengun W/O Screws
In Commercial Distribution

  • 07290114064149 ()
700-000307-01

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

  • 07290114064033 ()
700-006011-00

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

  • 07290114064026 ()
750-000020-00

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

  • 07290114064019 ()
700-006000-00

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

  • 07290114063326 ()
700-006008-00

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

  • 07290114063296 ()
750-000027-00

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

  • 07290114063289 ()
750-000025-00

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

  • 07290114062985 ()
700-006010-00

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

  • 07290114062510 ()
750-000070-00

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

  • 07290114062381 ()
700-005023-00

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

  • 07290114062374 ()
700-006009-00

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

  • 07290114062367 ()
750-000023-00

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

  • 07290114062305 ()
750-000020-00

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

  • 17290114061770 ()
  • 07290114061773 ()
STR-000080-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart Main Unit
In Commercial Distribution

  • 07290114061544 ()
700-006007-00

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

  • 07290114061520 ()
700-006000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Ruler and DBs holder thumb screw
In Commercial Distribution

  • 07290114061414 ()
344-001110-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Frame adapter thumb screw
In Commercial Distribution

  • 07290114061407 ()
700-001330-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Leksell X/Y frame adapter
In Commercial Distribution

  • 07290114061391 ()
341-309001-00

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

  • 07290114061322 ()
215-001111-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
BenGun and Microelectrode holder screws
In Commercial Distribution

  • 07290114061315 ()
344-000056-00

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

  • 07290114061308 ()
365-000015-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Microelectrode Holder “X” W/O Screws
In Commercial Distribution

  • 07290114061292 ()
341-000311-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Microelectrode Holder “+” W/O Screws
In Commercial Distribution

  • 07290114061285 ()
341-000312-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Leksell Non-X/Y frame adapter
In Commercial Distribution

  • 07290114061261 ()
341-309011-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Universal LeadConfirm Holder
In Commercial Distribution

  • 07290114061254 ()
700-S01000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Universal Frame Lead Holder - Short
In Commercial Distribution

  • 07290114061247 ()
700-S00422-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Universal Frame Lead Holder - Long
In Commercial Distribution

  • 07290114061230 ()
700-S00420-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Mechanical Accessories Sterilization Tray
In Commercial Distribution

  • 07290114061223 ()
366-000022-22

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Headstage Sterilization Tray
In Commercial Distribution

  • 07290114061216 ()
366-000122-22

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
1
In Commercial Distribution

  • 07290114061209 ()
366-000322-22

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
1
In Commercial Distribution

  • 07290114061193 ()
366-000422-22

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

  • 07290114060967 ()
700-006008-00

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

  • 07290114060899 ()
750-000027-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 6.0
In Commercial Distribution

  • 07290114060882 ()
750-000025-00

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

  • 07290114060790 ()


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

  • 07290114060561 ()
750-000070-00

  • Depth electrode
microTargeting™ Electrodes, differential, tungsten, sterile, LZAP
FHC, INC.
MTDWLP(SP)(MP4)-00915
In Commercial Distribution

  • 10873263009151 ()
  • 00873263009154 ()
MTDWLP(SP)(MP4)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(AR)(AR7)-00865
In Commercial Distribution

  • 00873263008652 ()
  • 10873263008659 ()
MTDWZP(AR)(AR7)

  • Depth electrode
microTargeting™ Platform Platinum 5X Sterile
FHC, INC.
45375Z-00800
In Commercial Distribution

  • 10873263008000 ()
  • 00873263008003 ()

  • Outer Diameter: 0.56 Millimeter
  • Impedance: Megaohms
  • Length: 220.72 Millimeter
  • Length: 212.72 Millimeter
  • Length: 3 Millimeter
45375Z

  • Depth electrode
microTargeting™ Platform Electrodes 5x Sterile
FHC, INC.
44375Z-00798
In Commercial Distribution

  • 10873263007980 ()
  • 00873263007983 ()

  • Length: 3 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 212.72 Millimeter
  • Length: 220.72 Millimeter
44375Z

  • Depth electrode
microTargeting™ Single Frame Platinum 5X Sterile
FHC, INC.
35385Z-00796
In Commercial Distribution

  • 10873263007966 ()
  • 00873263007969 ()

  • Length: 3 Millimeter
  • Length: 263.4 Millimeter
  • Outer Diameter: 0.86 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
35385Z

  • Depth electrode
microTargeting™ Frame Single Tungsten 5X Sterile
FHC, INC.
34385Z-00794
In Commercial Distribution

  • 10873263007942 ()
  • 00873263007945 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.77 Millimeter
  • Length: 263.4 Millimeter
  • Length: 3 Millimeter
  • Length: 271.4 Millimeter
34385Z

  • Depth electrode
microTargeting™ Array Frame Platinum 5X Sterile
FHC, INC.
25375Z-00792
In Commercial Distribution

  • 10873263007928 ()
  • 00873263007921 ()

  • Length: 3 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 276.5 Millimeter
  • Length: 268.5 Millimeter
25375Z

  • Depth electrode
microTargeting™ Array Electrodes 5x Sterile
FHC, INC.
22375Z-00790
In Commercial Distribution

  • 10873263007904 ()
  • 00873263007907 ()

  • Length: 268.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 3 Millimeter
  • Length: 276.5 Millimeter
22375Z

  • Depth electrode
Guidline 4000 ™ 5.0 1.5m Special-use Lead, 1x For use with microTargeting ™ Electrodes
FHC, INC.
C0232-00781
In Commercial Distribution

  • 00873263007815 ()

  • Length: 1.5 Meter
C0232

  • Depth electrode
GL5 UE Patient Lead, 1.5m, presterile
FHC, INC.
C0231-00691
In Commercial Distribution

  • 00873263006917 ()

  • Length: 1.5 Meter
C0231

  • Depth electrode
GL5 UE Patient Lead, 3m, presterile
FHC, INC.
C0230-00690
In Commercial Distribution

  • 00873263006900 ()
C0230

  • Depth electrode
microTargeting(TM) Electrode, Back loaded, Platinum/Iridium with Glass Insulation, Presterile
FHC, INC.
MTBPBP(DT1)-00672
In Commercial Distribution

  • 10873263006723 ()
  • 00873263006726 ()

  • Length: 300 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.63 Millimeter
  • Impedance: Megaohms
MTBPBP(DT1)

  • Depth electrode
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