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.
NeuroProbe
In Commercial Distribution

  • 17290014954974 ()
  • 07290014954977 ()
STR-94685Z-00

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

  • 17290014954967 ()
  • 07290014954960 ()
STR-94685L-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Sterile Neuro Omega AlphaProbe electrode's cable 10 CH
In Commercial Distribution

  • 17290014954950 ()
  • 07290014954953 ()
STR-000664-21

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

  • 17290014954943 ()
  • 07290014954946 ()
STR-AP9080-00

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

  • 07290014954939 ()
700-006010-00

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Standard
In Commercial Distribution

  • 17290014954905 ()
  • 07290014954908 ()
STR-019176-00

  • Intracerebral cannula, implantable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Standard
In Commercial Distribution

  • 17290014954899 ()
  • 07290014954892 ()
366-019176-00

  • Intracerebral cannula, implantable
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.
Shielded
In Commercial Distribution

  • 17290014954875 ()
  • 07290014954878 ()
STR-050925-00

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

  • 17290014954868 ()
  • 07290014954861 ()
STR-000136-00

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

  • 17290014954851 ()
  • 07290014954854 ()
366-000426-00

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

  • 07290014954847 ()
  • 17290014954844 ()
STR-001080-00

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

  • 07290014954830 ()
  • 17290014954837 ()
STR-000081-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Array electrode insertion tube
In Commercial Distribution

  • 07290014954823 ()
  • 17290014954820 ()
STR-70ITAR-00

  • Intracerebral cannula, implantable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Sterile electrode's cable
In Commercial Distribution

  • 17290014954813 ()
  • 07290014954816 ()
  • 37290014954817 ()
STR-000664-11

  • Electrical-only medical device connection cable, single-use
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Insertion Tube Set 15mm above
In Commercial Distribution

  • 07290014954809 ()
  • 17290014954806 ()
STR-66IT07-00

  • Intracerebral cannula, implantable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Insertion Tube Set 20mm above
In Commercial Distribution

  • 07290014954793 ()
  • 17290014954790 ()
STR-66IT05-00

  • Intracerebral cannula, implantable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Set 40mm above
In Commercial Distribution

  • 07290014954786 ()
  • 17290014954783 ()
STR-66IT01-00

  • Intracerebral cannula, implantable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Lead Insertion
In Commercial Distribution

  • 07290014954779 ()
  • 17290014954776 ()
STR-66IT19-00

  • Intracerebral cannula, implantable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Extractor
In Commercial Distribution

  • 07290014954762 ()
  • 17290014954769 ()
STR-70CNET-00

  • Intracerebral cannula, implantable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Stylet
In Commercial Distribution

  • 07290014954755 ()
  • 17290014954752 ()
STR-000237-00

  • Intracerebral cannula, implantable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Shielded
In Commercial Distribution

  • 07290014954526 ()
  • 17290014954523 ()
STR-009080-00

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

  • 07290014954519 ()
  • 17290014954516 ()
STR-22675L-00

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

  • 07290014954502 ()
  • 17290014954509 ()
17290014954509

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

  • 07290014954496 ()
  • 17290014954493 ()
STR-34685L-00

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

  • 07290014954489 ()
  • 17290014954486 ()
STR-34685Z-00

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

  • 07290014954472 ()
  • 17290014954479 ()
STR-000925-00

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

  • 07290014954458 ()
  • 17290014954455 ()
STR-000425-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
5 channels MER only
In Commercial Distribution

  • 17290014954202 ()
  • 07290014954205 ()
STR-001419-55

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
4 channels MER only
In Commercial Distribution

  • 17290014954196 ()
  • 07290014954199 ()
STR-001419-44

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
3 channels MER only
In Commercial Distribution

  • 17290014954189 ()
  • 07290014954182 ()
STR-001419-33

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2 channels MER only
In Commercial Distribution

  • 17290014954172 ()
  • 07290014954175 ()
STR-001419-22

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
1 channel MER only
In Commercial Distribution

  • 17290014954165 ()
  • 07290014954168 ()
STR-001419-11

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
5 channels
In Commercial Distribution

  • 17290014954158 ()
  • 07290014954151 ()
STR-000526-55

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
4 channels
In Commercial Distribution

  • 17290014954141 ()
  • 07290014954144 ()
STR-000526-44

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
3 channels
In Commercial Distribution

  • 17290014954134 ()
  • 07290014954137 ()
STR-000526-33

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2 channels
In Commercial Distribution

  • 17290014954127 ()
  • 07290014954120 ()
STR-000526-22

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
1 channel
In Commercial Distribution

  • 17290014954110 ()
  • 07290014954113 ()
STR-000526-11

  • Neurological stereotactic surgery system
Sterile Nexframe/Starfix Stainless Steel Guide Tube (cannula) and Stylet
ALPHA OMEGA ENGINEERING CO. LTD.
Standard
In Commercial Distribution

  • 17290014954103 ()
  • 07290014954106 ()
STR-021621-00

  • Intracerebral cannula, implantable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Sterile electrode's cable
In Commercial Distribution

  • 17290014954097 ()
  • 07290014954090 ()
  • 37290014954091 ()
STR-000664-00

  • Electrical-only medical device connection cable, single-use
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart Main Unit
In Commercial Distribution

  • 07290014954083 ()


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

  • 17290014954073 ()
  • 07290014954076 ()
STR-222291-00

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

  • 07290014954069 ()
700-006000-00

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav
In Commercial Distribution

  • 07290014954052 ()
700-006002-00

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 17290014954035 ()
  • 07290014954038 ()
366-050925-10

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Drive-Head Stage
In Commercial Distribution

  • 07290014954021 ()
750-000025-00

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Drive
In Commercial Distribution

  • 07290014954014 ()
750-000027-00

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290016450446 ()
  • 17290016450443 ()
366-000025-00

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

  • 07290016450439 ()
  • 17290016450436 ()
366-001124-00

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

  • 07290016450422 ()
  • 17290016450429 ()
366-001024-00

  • Depth electrode
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