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 MER Headstage
In Commercial Distribution

  • 07290014954991 ()
750-000023-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 17290014954882 ()
  • 07290014954885 ()
366-222291-00

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

  • 17290014954363 ()
  • 07290014954366 ()
366-000136-00

  • 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
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with NeuroFortis Drive Headstage + 2 basic stimulation Slots
In Commercial Distribution

  • 27290114063177 ()
NOW-NFF000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with NeuroFortis Drive Headstage + 1 basic stimulation Slot
In Commercial Distribution

  • 27290114063160 ()
NOW-NF0000-00

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

  • 27290114063153 ()
700-026008-00

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

  • 27290114063146 ()
700-026009-00

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

  • 27290114063139 ()
700-026010-00

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

  • 27290114063016 ()
NSW-026010-55

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

  • 27290114062460 ()
700-026000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Universal DBS holder silicone sleeve - Pack of 5
In Commercial Distribution

  • 27290114061371 ()
341-011305-05

  • 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.
NeuroNav with MER Headstage
In Commercial Distribution

  • 27290114060879 ()
NNW-025023-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega drive + 1 basic stimulation Slot
In Commercial Distribution

  • 27290114060770 ()
NOW-DF0000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with NeuroFortis drive + 1 basic stimulation Slot
In Commercial Distribution

  • 27290114060756 ()
NOW-NF0000-00

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

  • 27290114060589 ()
700-026009-00

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

  • 27290114060572 ()
700-026010-00

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

  • 27290114060442 ()
NSW-006008-55

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

  • 27290114060435 ()
NSW-026010-55

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

  • 27290016450990 ()
700-020847-00

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

  • 27290016450952 ()
700-020834-00

  • 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.
NeuroOmega Drive Headstage Kit
In Commercial Distribution

  • 27290016450198 ()
750-020021-00

  • 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.
NeuroNav MER HeadStage KIT
In Commercial Distribution

  • 27290016450143 ()
700-025023-00

  • Depth electrode
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