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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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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.
FC1012-00153
Not in Commercial Distribution

  • 00873263001530 ()
FC1012

  • Intracerebral cannula, implantable
  • Neurosurgical micro targeting drive
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
5 French Coaxial Micro-Introducer Kit
Greatbatch Ltd
1012868-006
In Commercial Distribution

  • 00821329400346 ()
  • 10821329400343 ()

  • .018" [.47 mm] Nt/AuW Straight Tip Guidewire 45.0 cm
  • Needle, .55 mm ID, 0.9 mm OD, Echo Tip, 21 Ga. x 69.9 mm
  • Dilator 0.4 mm ID, 1.1 mm OD, 11.8 cm Length
  • 5 F Sheath 0.9 mm ID, 9.3 cm Length
  • Length: 9.3 Centimeter
MK5183

  • Vascular catheter introduction set, nonimplantable
5 French Coaxial Micro-Introducer Kit
Greatbatch Ltd
1012868-005
In Commercial Distribution

  • 00821329400339 ()
  • 10821329400336 ()

  • .018" [.47 mm] SS/AuW Straight Tip Guidewire 45.0 cm
  • Needle, .55 mm ID, 0.9 mm OD, Echo Tip, 21 Ga. x 69.9 mm
  • Dilator 0.4 mm ID, 1.1 mm OD, 11.8 cm Length
  • 5 F Sheath 0.9 mm ID, 9.3 cm Length
  • Length: 9.3 Centimeter
MK5182

  • Vascular catheter introduction set, nonimplantable
5 French Coaxial Micro-Introducer Kit
Greatbatch Ltd
1012868‐004
In Commercial Distribution

  • 10821329400329 ()
  • 00821329400322 ()

  • .018" [.47 mm] SS/SS Straight Tip Guidewire 45.0 cm
  • Needle, .55 mm ID, 0.9 mm OD, Echo Tip, 21 Ga. x 69.9 mm
  • Dilator 0.4 mm ID, 1.1 mm OD, 11.8 cm Length
  • 5 F Sheath 0.9 mm ID, 9.3 cm Length
  • Length: 9.3 Centimeter
MK5181

  • Vascular catheter introduction set, nonimplantable
4 French Coaxial Micro-Introducer Kit
Greatbatch Ltd
1012868‐003
In Commercial Distribution

  • 00821329400315 ()
  • 10821329400312 ()

  • .018" [.47 mm] Nt/AuW Straight Tip Guidewire 45.0 cm
  • Needle, .55 mm ID, 0.9 mm OD, Echo Tip, 21 Ga. x 69.9 mm
  • Dilator 0.4 mm ID, 1.1 mm OD, 11.8 cm Length
  • 4 F Sheath 0.9 mm ID, 9.3 cm Length
  • Length: 9.3 Centimeter
MK4183

  • Vascular catheter introduction set, nonimplantable
4 French Coaxial Micro-Introducer Kit
Greatbatch Ltd
1012868‐002
In Commercial Distribution

  • 10821329400305 ()
  • 00821329400308 ()

  • .018" [.47 mm] SS/AuW Straight Tip Guidewire 45.0 cm
  • Needle, .55 mm ID, 0.9 mm OD, Echo Tip, 21 Ga. x 69.9 mm
  • Dilator 0.4 mm ID, 1.1 mm OD, 11.8 cm Length
  • 4 F Sheath 0.9 mm ID, 9.3 cm Length
  • Length: 9.3 Centimeter
MK4182

  • Vascular catheter introduction set, nonimplantable
4 French Coaxial Micro-Introducer Kit
Greatbatch Ltd
1012868‐001
In Commercial Distribution

  • 00821329400292 ()
  • 10821329400299 ()

  • .018" [.47 mm] SS/SS Straight Tip Guidewire 45.0 cm
  • Needle, .55 mm ID, 0.9 mm OD, Echo Tip, 21 Ga. x 69.9 mm
  • Dilator 0.4 mm ID, 1.1 mm OD, 11.8 cm Length
  • 4 F Sheath 0.9 mm ID, 9.3 cm Length
  • Length: 9.3 Centimeter
MK4181

  • Vascular catheter introduction set, nonimplantable
No Description
FLEXICARE MEDICAL LIMITED
038-971-025MU
In Commercial Distribution

  • 05055788772736 ()


  • Basic endotracheal tube, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-961-025MU
In Commercial Distribution

  • 05055788732341 ()


  • Basic endotracheal tube, single-use
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