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.
Headstage cable
In Commercial Distribution

  • 07290114061339 ()
190-000375-00

  • Neurological stereotactic surgery system
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.
αCare SENS
In Commercial Distribution

  • 07290114061186 ()
ACS-000000-LS

  • Medical equipment clinical data interfacing software
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
αCare SENS
In Commercial Distribution

  • 07290114061179 ()
ACS-000000-00

  • Medical equipment clinical data interfacing software
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Standard
In Commercial Distribution

  • 07290114061094 ()
  • 17290114061091 ()
STR-S00021-51

  • Intracerebral cannula, implantable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Sterile NeuroSmart/NeuroNav MER LeadConfirm M_S Cable
In Commercial Distribution

  • 17290114061084 ()
  • 07290114061087 ()
STR-S00766-00

  • Electrical-only medical device connection cable, single-use
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Sterile NeuroSmart/NeuroNav MER LeadConfirm M Cable
In Commercial Distribution

  • 07290114061070 ()
  • 17290114061077 ()
STR-000766-00

  • Electrical-only medical device connection cable, single-use
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Sterile NeuroSmart/NeuroNav LeadConfirm M_S Cable
In Commercial Distribution

  • 17290114061060 ()
  • 07290114061063 ()
STR-S00074-00

  • Electrical-only medical device connection cable, single-use
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Sterile Neuro Omega MER LeadConfirm M_S Cable
In Commercial Distribution

  • 17290114061053 ()
  • 07290114061056 ()
STR-S00840-00

  • Electrical-only medical device connection cable, single-use
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Sterile LeadConfirm M_S Cable
In Commercial Distribution

  • 17290114061046 ()
  • 07290114061049 ()
STR-S00041-00

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

  • 17290114061039 ()
  • 07290114061032 ()
STR-S00021-31

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

  • 07290114061025 ()
  • 17290114061022 ()
STR-S21621-00

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

  • 17290114061015 ()
  • 07290114061018 ()
STR-S20121-00

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

  • 17290114061008 ()
  • 07290114061001 ()
STR-S19221-00

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

  • 07290114060998 ()
  • 17290114060995 ()
STR-S08221-00

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

  • 07290114060981 ()
  • 17290114060988 ()
STR-S07721-00

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

  • 07290114060974 ()
  • 17290114060971 ()
STR-S00021-00

  • Intracerebral cannula, implantable
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.
Sterile electrode's cable
In Commercial Distribution

  • 17290114060926 ()
  • 07290114060929 ()
  • 37290114060920 ()
STR-000730-00

  • Electrical-only medical device connection cable, single-use
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.
Plug Type L-5.5mm
In Commercial Distribution

  • 07290114060875 ()
190-000117-11

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Sterile NeuroSmart/NeuroNav LeadConfirm M Adaptor
In Commercial Distribution

  • 17290114060865 ()
  • 07290114060868 ()
STR-000075-00

  • Electrical-only medical device connection cable, single-use
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type N-4 mm
In Commercial Distribution

  • 07290114060851 ()
190-000117-15

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type K
In Commercial Distribution

  • 07290114060844 ()
190-000117-14

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Sterile Neuro Omega LeadConfirm A Adaptor
In Commercial Distribution

  • 17290114060834 ()
  • 07290114060837 ()
STR-000074-00

  • Electrical-only medical device connection cable, single-use
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type D
In Commercial Distribution

  • 07290114060820 ()
190-000117-12

  • 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.
Plug Type H
In Commercial Distribution

  • 07290114060554 ()
190-000117-09

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type F
In Commercial Distribution

  • 07290114060547 ()
190-000117-08

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type I
In Commercial Distribution

  • 07290114060530 ()
190-000117-07

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type M
In Commercial Distribution

  • 07290114060523 ()
190-000117-05

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type L-4mm
In Commercial Distribution

  • 07290114060516 ()
190-000117-04

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type G
In Commercial Distribution

  • 07290114060493 ()
190-000117-02

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Sterile Neuro Omega LeadConfirm A Adaptor
In Commercial Distribution

  • 17290114060476 ()
  • 07290114060479 ()
STR-000073-00

  • Electrical-only medical device connection cable, single-use
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Sterile Neuro Omega LeadConfirm M Adaptor
In Commercial Distribution

  • 17290114060452 ()
  • 07290114060455 ()
STR-000071-10

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

  • 07290114064545 ()
407-000024-00

  • Depth electrode
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