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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microTargeting Controller with encoder option for use with STar and mT Drives
FHC, INC.
FC1007-00143
In Commercial Distribution

  • 00873263001431 ()
FC1007

  • Neurosurgical micro targeting drive
microTargeting Single Procedure Kit, with microElectrode, tubes, sterile drape sleeve and cable. Contains: IT(BP2): Insertion Tube. 2x MTDWLN(BP)(BP7): microTargeting Electrode. PT(BP2): Protective Tube. Sterile Drape Sleeve for microTargeting motor FC1020 Electrode Lead Individual Specifications: IT(BP2) - 183mm tube length, 1.829mm OD, 1.6mm ID, 184mm stylet (not including collar). MTDWLN(BP)(BP7) - 271.4mm electrode length, 10mm differential, 256.4mm protective tube length, 0.77mm OD. 1Meg DZAP(L) PT(PB2) - 181mm tube length, 1.47mm OD, 0.99mm ID OD: 0.77mm
FHC, INC.
KTF1001-00133
Not in Commercial Distribution

  • 00873263001332 ()
KTF1001

  • Patient surgical drape, single-use
  • Intracerebral cannula, implantable
  • Depth electrode
microTargeting Array Electrode Insertion Tube Set, nonsterile, for use with mT Drive. Contains 6 of IT(AR1), 6 of IT(AR2), and 1 of IT(AR3). Individual Specifications: IT(AR1): Electrode Insertion Tube - 239.9mm, OD=0.88mm, ID=0.58mm. IT(AR2): Lower Guide Spacer - OD=1.83mm, ID=0.97mm (does not enter brain). IT(AR3): Lead Insertion Tube - 239.9mm, OD=1.83mm, ID=1.60mm. Also contains one 66-AC-AR Array Electrode Carrier and one 66-CN-ET Electrode Extraction Tool.
FHC, INC.
FC1012-00131
Not in Commercial Distribution

  • 00873263001318 ()
FC1012

  • Neurosurgical micro targeting drive
  • Intracerebral cannula, implantable
microTargeting Single Electrode Insertion Tube Set Contains: 66-IT-01 (One IT(BP2), One PT(BP2), One Spacer Cleaning Tool, One Electrode Carrier, One Shielded Electrode Carrier) depth when used with frame and Star or mT Drive is 40mm above target Individual Specifications: IT(BP2): Length=183mm, OD=1.83mm, ID=1.60mm PT(BP2): Length=181mm, OD=1.47mm, ID=0.99mm
FHC, INC.
FC1011-00130
Not in Commercial Distribution

  • 00873263001301 ()

  • Length: 40 Millimeter
FC1011

  • Intracerebral cannula, implantable
  • Neurosurgical micro targeting drive
STar(TM) Drive Locking Array Electrode Carrier
FHC, INC.
FC8008-00083
Not in Commercial Distribution

  • 00873263000830 ()
FC8008

  • Neurosurgical micro targeting drive
Array Electrode Carrier and Clamp for microTargeting(TM) Drive
FHC, INC.
FC1021-00061
Not in Commercial Distribution

  • 00873263000618 ()
FC1021

  • Neurosurgical micro targeting drive
Accesories Kit for microTargeting Drive
FHC, INC.
FC1017-00019
In Commercial Distribution

  • 00873263000199 ()
FC1017

  • Neurosurgical micro targeting drive
Depth Stop 1.6mm
INTEGRA LIFESCIENCES CORPORATION
DS16
In Commercial Distribution

  • 10381780412212 ()

  • 1.6 mm
DS16

  • Stereotactic radiosurgical invasive head frame
No Description
Biomet Orthopedics, LLC
86-555500
In Commercial Distribution

  • 00880304461413 ()
86-555500

  • Surgical instrument handle, non-torque-limiting
No Description
7D Surgical ULC
11-0010
In Commercial Distribution

  • 00628341520461 ()


  • Device sterilization/disinfection container, reusable
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