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 Class Implantable

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Unibody™ Bone Fiducials (13mm) for use with the Nexframe® Sterotactic System
FHC, INC.
FM-4013-00857
In Commercial Distribution

  • 00873263008577 ()
  • 10873263008574 ()
FM-4013

  • Neurological stereotactic surgery system
Unibody™ Bone Fiducials (10mm) for use with the Nexframe® Sterotactic System
FHC, INC.
FM-4010-00856
In Commercial Distribution

  • 00873263008560 ()
  • 10873263008567 ()
FM-4010

  • Neurological stereotactic surgery system
Unibody™ Bone Fiducials (7mm) for use with the Nexframe® Sterotactic System
FHC, INC.
FM-4007-00855
In Commercial Distribution

  • 00873263008553 ()
  • 10873263008550 ()
FM-4007

  • Neurological stereotactic surgery system
STar™ Drive Single Electrode Insertion Locking Carrier, 2x, can also be used with the microTargeting(TM) Drive
FHC, INC.
FC8010-00834
In Commercial Distribution

  • 00873263008348 ()
  • 10873263008345 ()
FC8010

  • Neurosurgical micro targeting drive
33 cm Lead Insertion Tube Set, for microTargeting STar Drive
FHC, INC.
FC1023-00820
In Commercial Distribution

  • 10873263008208 ()
  • 00873263008201 ()
FC1023

  • Intracerebral cannula, nonimplantable, single-use
microTargeting™ MR Lead Insertion Tube 1 mm above target with Ceramic Stylet at target, non-sterile, 2x
FHC, INC.
66-IT-MR3-00807
In Commercial Distribution

  • 10873263008079 ()
  • 00873263008072 ()

  • Lumen/Inner Diameter: 1.6 Millimeter
  • Outer Diameter: 1.8 Millimeter
  • Length: 210.85 Millimeter
66-IT-MR3

  • Intracerebral cannula, nonimplantable, single-use
1.6 x 10mm Cranial Bone Screws (3)
FHC, INC.
SR-10-00804
In Commercial Distribution

  • 00873263008041 ()
  • 10873263008048 ()
SR-10

  • Neurological stereotactic surgery system
microTargeting MR Lead Insertion Tube with Ceramic Stylet, nonsterile
FHC, INC.
66-IT-MR3-00803
Not in Commercial Distribution

  • 10873263008031 ()
  • 00873263008034 ()

  • Lumen/Inner Diameter: 1.6 Millimeter
  • Outer Diameter: 1.8 Millimeter
  • Length: 211.85 Millimeter
66-IT-MR3

  • Intracerebral cannula, nonimplantable, single-use
Unibody™ Bone Fiducials (13mm) for use with the Nexframe® Stereotactic System
FHC, INC.
FM-4013-00775
Not in Commercial Distribution

  • 10873263007751 ()
  • 00873263007754 ()
FM-4013

  • Neurological stereotactic surgery system
Unibody™ Bone Fiducials (10mm) for use with the Nexframe® Stereotactic System
FHC, INC.
FM-4010-00774
Not in Commercial Distribution

  • 10873263007744 ()
  • 00873263007747 ()
FM-4010

  • Neurological stereotactic surgery system
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