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

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

  • Depth electrode
GUIDE FOR Ø 2.45MM ACCESSORIES ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
INSTRUMENT GUIDE
In Commercial Distribution

  • 03664539003917 ()
ACS-789/120R

  • Depth electrode
GUIDE FOR Ø 2.45MM ACCESSORIES ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
INSTRUMENT GUIDE
In Commercial Distribution

  • 03664539003900 ()
ACS-789/82R

  • Depth electrode
microTargeting™ Electrode, tungsten, sterile, D.ZAP(Z)
FHC, INC.
MTDWZP(AO)(A11)-00921
In Commercial Distribution

  • 10873263009212 ()
  • 00873263009215 ()
MTDWZP(AO)(A11)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(BP)(BP8)-00459
Not in Commercial Distribution

  • 10873263004590 ()
  • 00873263004593 ()

  • Length: 3 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Length: 263.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
MTDWZP(BP)(BP8)

  • Depth electrode
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003034 ()
203511 SD

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003027 ()

  • Length: 30 Millimeter
  • Length: 35 Millimeter
  • Length: 40 Millimeter
  • Length: 45 Millimeter
  • Length: 50 Millimeter
  • Length: 55 Millimeter
  • Length: 60 Millimeter
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man203511

  • Intraurethral valve/pump
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