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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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NP-1000 Nexprobe Image-guided Probe for use with the Nexframe Stereotactic System and Medtronic StealthStation Navigation Systems
FHC, INC.
NP-1000-00872
In Commercial Distribution

  • 00873263008720 ()
NP-1000

  • Neurological stereotactic surgery system
MI-2000 NEXDRIVE™ Micropositioning Drive
FHC, INC.
MI-2000-00871
In Commercial Distribution

  • 00873263008713 ()
MI-2000

  • Neurological stereotactic surgery system
MI-1000 NEXDRIVE™ Micropositioning Drive with Display Option
FHC, INC.
MI-1000-00870
In Commercial Distribution

  • 00873263008706 ()
MI-1000

  • Neurological stereotactic surgery system
Bilateral Nexframe System for Medtronic StealthStation Navigation Systems
FHC, INC.
DB-2040-00869
In Commercial Distribution

  • 00873263008690 ()
DB-2040

  • Neurological stereotactic surgery system
microTargeting Insertion Tube with Stylet, Sterile
FHC, INC.
66-IT-AO11P-00867
In Commercial Distribution

  • 10873263008673 ()
  • 00873263008676 ()
66-IT-AO11P

  • Intracerebral cannula, nonimplantable, single-use
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 Insertion Tube with Stylet, 258.9mm
FHC, INC.
66-IT-ME1P-00858
In Commercial Distribution

  • 10873263008581 ()
  • 00873263008584 ()
66-IT-ME1P

  • Intracerebral cannula, nonimplantable, reusable
D.Zap Single Insertion-Used in KTF1001, not sold individually
FHC, INC.
66-IT-40L-00851
In Commercial Distribution

  • 00873263008515 ()
66-IT-40L

  • Intracerebral cannula, nonimplantable, single-use
33 cm Lead Insertion Tube Set, for use with microTargeting STar Drive
FHC, INC.
70-IT-1023-00849
In Commercial Distribution

  • 10873263008499 ()
  • 00873263008492 ()
70-IT-1023

  • Intracerebral cannula, nonimplantable, single-use
microTargeting Nexframe Insertion Tube Set with Stylet, Sterile. Contains: IT(KH3): Insertion Tube - 205.6mm tube length, 1.83mm od, 1.6mm id PT(KH1): Protective Tube - 0.58mm id. Nexframe Stylet.
FHC, INC.
66-IT-4010S-00848
In Commercial Distribution

  • 10873263008482 ()
  • 00873263008485 ()
66-IT-4010S

  • Intracerebral cannula, nonimplantable, single-use
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