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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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NeuroProbe - 07290014954311

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290014954311 ()
  • 17290014954318 ()
STR-000080-00

  • Depth electrode

NeuroProbe - 07290014954076

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-Shielded
In Commercial Distribution

  • 17290014954073 ()
  • 07290014954076 ()
STR-222291-00

  • Depth electrode

Leg Harness MasterVest™, Mod. 66 - 00887761984110

Gait rehabilitation system harness
Liko AB
3666006
In Commercial Distribution

  • 00887761984110 ()


  • Gait rehabilitation system harness

Leg Harness MasterVest™, Mod. 66 - 00887761984103

Gait rehabilitation system harness
Liko AB
3666005
In Commercial Distribution

  • 00887761984103 ()


  • Gait rehabilitation system harness

Leg Harness MasterVest™, Mod. 66 - 00887761984097

Gait rehabilitation system harness
Liko AB
3666004
In Commercial Distribution

  • 00887761984097 ()


  • Gait rehabilitation system harness

Liko MasterVest™, front closure, Mod. 64 - 00887761983847

Gait rehabilitation system harness
Liko AB
3564118
In Commercial Distribution

  • 00887761983847 ()


  • Gait rehabilitation system harness

Liko MasterVest™, front closure, Mod. 64 - 00887761983830

Gait rehabilitation system harness
Liko AB
3564117
In Commercial Distribution

  • 00887761983830 ()


  • Gait rehabilitation system harness

Liko MasterVest™, front closure, Mod. 64 - 00887761983823

Gait rehabilitation system harness
Liko AB
3564116
In Commercial Distribution

  • 00887761983823 ()


  • Gait rehabilitation system harness

Liko MasterVest™, front closure, Mod. 64 - 00887761983816

Gait rehabilitation system harness
Liko AB
3564115
In Commercial Distribution

  • 00887761983816 ()


  • Gait rehabilitation system harness

Liko MasterVest™, front closure, Mod. 64 - 00887761983809

Gait rehabilitation system harness
Liko AB
3564114
In Commercial Distribution

  • 00887761983809 ()


  • Gait rehabilitation system harness

Liko MasterVest™, Mod. 60 - 00887761983793

Gait rehabilitation system harness
Liko AB
3560118
In Commercial Distribution

  • 00887761983793 ()


  • Gait rehabilitation system harness

Liko MasterVest™, Mod. 60 - 00887761983786

Gait rehabilitation system harness
Liko AB
3560117
In Commercial Distribution

  • 00887761983786 ()


  • Gait rehabilitation system harness

Liko MasterVest™, Mod. 60 - 00887761983779

Gait rehabilitation system harness
Liko AB
3560116
In Commercial Distribution

  • 00887761983779 ()


  • Gait rehabilitation system harness

Liko MasterVest™, Mod. 60 - 00887761983762

Gait rehabilitation system harness
Liko AB
3560115
In Commercial Distribution

  • 00887761983762 ()


  • Gait rehabilitation system harness

Liko MasterVest™, Mod. 60 - 00887761983755

Gait rehabilitation system harness
Liko AB
3560114
In Commercial Distribution

  • 00887761983755 ()


  • Gait rehabilitation system harness

Liko MasterVest™, Mod. 60 - 00887761983748

Gait rehabilitation system harness
Liko AB
3560113
In Commercial Distribution

  • 00887761983748 ()


  • Gait rehabilitation system harness

SYNCHROMED®II - 00763000422615

PUMP 8637-40 SM II 40ML EMAN SYMBL GRC
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00763000422615 ()


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED®II - 00763000422608

PUMP 8637-20 SM II 20ML EMAN SYMBL GRC
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00763000422608 ()


  • Implantable intrathecal infusion pump, programmable

E.M Adams co, inc. - 18100013407427

BELT
E.M. ADAMS, INC.
EP26-63391-1
Not in Commercial Distribution

  • 58100013407418 ()
  • 18100013407427 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407403

BELT
E.M. ADAMS, INC.
EP26-63375-1
Not in Commercial Distribution

  • 58100013407395 ()
  • 18100013407403 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407380

BELT
E.M. ADAMS, INC.
EP26-63350XL-1
Not in Commercial Distribution

  • 58100013407371 ()
  • 18100013407380 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407366

BELT
E.M. ADAMS, INC.
EP26-63350-1
Not in Commercial Distribution

  • 58100013407357 ()
  • 18100013407366 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407342

BELT
E.M. ADAMS, INC.
EP26-63340XL-1
Not in Commercial Distribution

  • 58100013407333 ()
  • 18100013407342 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness

SYNCHROMED® II - 00763000634100

PUMP 8637-40 SM II 40ML EMAN SYMBL
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00763000634100 ()

  • Reservoir Volume 40 ML


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED® II - 00763000634094

PUMP 8637-20 SM II 20ML EMAN SYMBL
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00763000634094 ()

  • Reservoir Volume 20 ML


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED™ III - 00763000597030

PUMP 8667-40 SYNCHROMEDIII INFUSION EMAN
MEDTRONIC, INC.
8667-40
In Commercial Distribution

  • 00763000597030 ()

  • Reservoir Volume 40 mL


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED™ III - 00763000597023

PUMP 8667-20 SYNCHROMEDIII INFUSION EMAN
MEDTRONIC, INC.
8667-20
In Commercial Distribution

  • 00763000597023 ()

  • Reservoir Volume 20 mL


  • Implantable intrathecal infusion pump, programmable

Integra® - 10381780037088

The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cortical electrical activity specifically at the undersurface of the temporal lobe. It has one platinum contact and is supplied with an insertion needle.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
EDSEP
Not in Commercial Distribution

  • M272EDSEP1 ()
  • 10381780037088 ()


  • Depth electrode

Auragen™ - 10381780036531

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU8D5L25
Not in Commercial Distribution

  • M272AU8D5L251 ()
  • 10381780036531 ()

  • 8 platinum contacts


  • Depth electrode

Auragen™ - 10381780036524

The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU8D10L5
Not in Commercial Distribution

  • M272AU8D10L51 ()
  • 10381780036524 ()

  • 8 platinum contacts


  • Depth electrode
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