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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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Depth Electrode - 00841823106681

No Description
Ad-Tech Medical Instrument Corporation
MM14A-SP05X-0AE
In Commercial Distribution

  • 00841823106681 ()
MM14A-SP05X-0AE

  • Depth electrode

Depth Electrode - 00841823106667

No Description
Ad-Tech Medical Instrument Corporation
MD01R-SP00X-000
In Commercial Distribution

  • 00841823106667 ()
MD01R-SP00X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823106308

No Description
Ad-Tech Medical Instrument Corporation
SD041-SP07X-A00
In Commercial Distribution

  • 00841823106308 ()
SD041-SP07X-A00

  • Depth electrode

Spencer Depth Probe Electrode - 00841823104236

No Description
Ad-Tech Medical Instrument Corporation
LD14R-SP05X-000
In Commercial Distribution

  • 00841823104236 ()
LD14R-SP05X-000

  • Depth electrode

Spencer Depth Probe Electrode - 00841823104229

No Description
Ad-Tech Medical Instrument Corporation
LD12R-SP05X-000
In Commercial Distribution

  • 00841823104229 ()
LD12R-SP05X-000

  • Depth electrode

Spencer Depth Probe Electrode - 00841823104212

No Description
Ad-Tech Medical Instrument Corporation
LD10R-SP45X-000
In Commercial Distribution

  • 00841823104212 ()
LD10R-SP45X-000

  • Depth electrode

Spencer Depth Probe Electrode - 00841823104205

No Description
Ad-Tech Medical Instrument Corporation
LD10R-SP05X-000
In Commercial Distribution

  • 00841823104205 ()
LD10R-SP05X-000

  • Depth electrode

Foramen Ovale Depth Electrode - 00841823103550

No Description
Ad-Tech Medical Instrument Corporation
FO06K-SP10X-000
In Commercial Distribution

  • 90841823103553 ()
  • 00841823103550 ()
FO06K-SP10X-000

  • Depth electrode

Prometra Programmable Pump - 00810335020242

Prometra II 40ml Programmable Pump
Flowonix Medical, Inc.
16827
In Commercial Distribution

  • 00810335020242 ()


  • Implantable intrathecal infusion pump, programmable

Prometra II Pump - 00810335020228

The Prometra II Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter. To help increase safety, the Prometra II Pump incorporates a safety valve (flow-activated valve or FAV) that will shut off drug flow to the patient in the event a high flow rate occurs, such as during an MRI. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer. The Prometra II Pump contains a metal bellows drug reservoir with a capacity of 20 milliliters (mL). The reservoir propellant is stored within the rigid housing surrounding the bellows and provides the driving pressure for the pump. The driving pressure on the reservoir forces the infusate through an outlet filter (0.22 pm), and into an electronically controlled flow metering valve-accumulator subsystem. The Infumorph passes from the flow metering subsystem, into the catheter access port then into the catheter for delivery to the intrathecal space.
Flowonix Medical, Inc.
13827
In Commercial Distribution

  • 00810335020228 ()


  • Implantable intrathecal infusion pump, programmable

Prometra Programmable Pump - 00810335020082

The Prometra Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter.
Flowonix Medical, Inc.
11827
In Commercial Distribution

  • 00810335020082 ()


  • Implantable intrathecal infusion pump, programmable

MEDSTREAM - 10886704072072

Refill Kit
Medos International Sàrl
91-4287
In Commercial Distribution

  • 10886704072072 ()
914287

  • Implantable intrathecal infusion pump, programmable

MEDSTREAM - 10886704071457

Refill Kit
Codman Neuro Sciences Sàrl
91-4285US
In Commercial Distribution

  • 20886704071454 ()
  • 10886704071457 ()
914285US

  • Implantable intrathecal infusion pump, programmable

NA - 10886704071440

Bolus Kit
Medos International Sàrl
91-4284US
In Commercial Distribution

  • 10886704071440 ()
914284US

  • Implantable intrathecal infusion pump, programmable

MEDSTREAM - 10886704064954

Refill Kit
Medos International Sàrl
91-4288
In Commercial Distribution

  • 20886704064951 ()
  • 10886704064954 ()
914288

  • Implantable intrathecal infusion pump, programmable

microTargeting™ Electrode - 10873263007959

microTargeting™ Single Frame Platinum 6x Non Sterile
FHC, INC.
35325Z-00795
In Commercial Distribution

  • 10873263007959 ()
  • 00873263007952 ()

  • Outer Diameter: 0.86 Millimeter
  • Length: 271.4 Millimeter
  • Length: 263.4 Millimeter
  • Length: 3 Millimeter
  • Impedance: Megaohms
35325Z

  • Depth electrode

microTargeting™ Electrodes - 10873263007553

microTargeting(TM) Electrodes, 5x, Sterile, Single or Array, 1 Meg, for use with NexFrame and mT Drive or NexDrive.
FHC, INC.
FC5000-00755
In Commercial Distribution

  • 10873263007553 ()
  • 00873263007556 ()

  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 0.56 Millimeter
  • Length: 234.2 Millimeter
  • Length: 249.2 Millimeter
FC5000

  • Depth electrode

microTargeting™ Electrodes - 10873263007522

microTargeting Differential Electrodes 5x, Sterile, Single and Array, DZAP(L), T=30 for use with Nexframe and STar Drive
FHC, INC.
FC2004-00752
In Commercial Distribution

  • 10873263007522 ()
  • 00873263007525 ()

  • Length: 227.2 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 242.2 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
FC2004

  • Depth electrode

microTargeting™ Electrode - 10873263007515

microTargeting Differential Electrode 5x, Sterile, Single and Array, D.ZAP(L) , T=30 for use with NexFrame and MT Drive or NexDrive
FHC, INC.
FC2003-00751
In Commercial Distribution

  • 10873263007515 ()
  • 00873263007518 ()

  • Length: 10 Millimeter
  • Length: 249.2 Millimeter
  • Length: 234.2 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Impedance: Megaohms
FC2003

  • Depth electrode

microTargeting™ Electrode - 10873263007508

microTargeting D.ZAP(L) Differential Electrode 5x, Sterile, Single, T=30 for use with Frame and STar or MT Drive
FHC, INC.
FC2002-00750
In Commercial Distribution

  • 10873263007508 ()
  • 00873263007501 ()

  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Length: 256.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
FC2002

  • Depth electrode

microTargeting™ Electrode - 10873263007492

microTargeting Differential Electrode 5x, D.ZAP(L), Sterile, Array, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC2001-00749
In Commercial Distribution

  • 10873263007492 ()
  • 00873263007495 ()

  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 261.5 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
FC2001

  • Depth electrode

microTargeting™ Electrode - 10873263007461

microTargeting Differential Electrode 5x, Sterile, Single, 1 Meg, T=30 for use with frame, STar or MT Drive
FHC, INC.
34680-00746
In Commercial Distribution

  • 10873263007461 ()
  • 00873263007464 ()

  • Length: 256.4 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 10 Millimeter
34680

  • Depth electrode

microTargeting™ Electrode - 10873263007454

microTargeting Differential Electrode 5x, Sterile, Array, 1 Meg, T=30 for use with frame, STar or MT Drive
FHC, INC.
22670-00745
In Commercial Distribution

  • 10873263007454 ()
  • 00873263007457 ()

  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Length: 261.5 Millimeter
22670

  • Depth electrode

microTargeting™ Electrodes - 10873263001292

microTargeting Differential Electrodes 5x, Sterile, Single and Array, DZAP(L), T=30 for use with Nexframe and STar Drive
FHC, INC.
FC2004-00129
Not in Commercial Distribution

  • 10873263001292 ()
  • 00873263001295 ()

  • Length: 227.2 Millimeter
  • Length: 242.2 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 10 Millimeter
FC2004

  • Depth electrode

microTargeting™ Electrode - 10873263001285

microTargeting Differential Electrode 5x, Sterile, Single and Array, D.ZAP(L) , T=30 for use with NexFrame and MT Drive or NexDrive
FHC, INC.
FC2003-00128
Not in Commercial Distribution

  • 10873263001285 ()
  • 00873263001288 ()

  • Length: 249.2 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 234.2 Millimeter
  • Length: 10 Millimeter
FC2003

  • Depth electrode

microTargeting™ Electrode - 10873263001278

microTargeting D.ZAP(L) Differential Electrode 5x, Sterile, Single, T=30 for use with Frame and STar or MT Drive
FHC, INC.
FC2002-00127
Not in Commercial Distribution

  • 10873263001278 ()
  • 00873263001271 ()

  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Length: 271.4 Millimeter
  • Length: 256.4 Millimeter
FC2002

  • Depth electrode

microTargeting™ Electrode - 10873263001261

microTargeting Differential Electrode 5x, D.ZAP(L), Sterile, Array, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC2001-00126
Not in Commercial Distribution

  • 10873263001261 ()
  • 00873263001264 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
  • Length: 261.5 Millimeter
  • Length: 276.5 Millimeter
FC2001

  • Depth electrode

microTargeting™ Electrode - 10873263001254

microTargeting Differential Electrode 5x, Sterile, Single, 1 Meg, T=30 for use with frame, STar or MT Drive
FHC, INC.
34680-00125
Not in Commercial Distribution

  • 10873263001254 ()
  • 00873263001257 ()

  • Impedance: Megaohms
  • Length: 256.4 Millimeter
  • Length: 271.4 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
34680

  • Depth electrode

microTargeting™ Electrode - 10873263001247

microTargeting Differential Electrode 5x, Sterile, Array, 1 Meg, T=30 for use with frame, STar or MT Drive
FHC, INC.
22670-00124
Not in Commercial Distribution

  • 10873263001247 ()
  • 00873263001240 ()

  • Length: 261.5 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
22670

  • Depth electrode

microTargeting™ Electrodes - 10873263001179

microTargeting(TM) Electrodes, 5x, Sterile, Single or Array, 1 Meg, for use with NexFrame and mT Drive or NexDrive.
FHC, INC.
FC5000-00117
Not in Commercial Distribution

  • 10873263001179 ()
  • 00873263001172 ()

  • Length: 249.2 Millimeter
  • Length: 10 Millimeter
  • Length: 234.2 Millimeter
  • Impedance: Megaohms
  • Length: 0.56 Millimeter
FC5000

  • Depth electrode

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

PMT® CORPORATION - SPHENOIDAL - 10650551092862

SPHENOIDAL ELECTRODE EEG CABLE 1.5MM SOCKET SET
PMT CORPORATION
2122
In Commercial Distribution

  • 10650551092862 ()
  • 00650551092865 ()
2122

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092855

PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, 2 LOOSE CONNECTORS
PMT CORPORATION
2102-32-09
In Commercial Distribution

  • 10650551092855 ()
  • 00650551092858 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 22 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-09

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092848

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
PMT CORPORATION
2102-32-05
In Commercial Distribution

  • 10650551092848 ()
  • 00650551092841 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 22 Gauge
  • Recording Length 0.25 Inch
2102-32-05

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092831

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-03
In Commercial Distribution

  • 10650551092831 ()
  • 00650551092834 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-03

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092824

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
PMT CORPORATION
2102-31-03
In Commercial Distribution

  • 10650551092824 ()
  • 00650551092827 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2102-31-03

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092817

STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2101-32-03
In Commercial Distribution

  • 10650551092817 ()
  • 00650551092810 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2101-32-03

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092800

STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
PMT CORPORATION
2101-31-03
In Commercial Distribution

  • 10650551092800 ()
  • 00650551092803 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2101-31-03

  • Depth electrode

DEPTHALON - 00650551150701

PLATINUM, 6 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL, 0.8MM OD, 2MM CONTACT LENGTH, 28.7MM RECORDING DEPTH, 5.33MM SPACING, 27CM MAIN TUBE LENGTH
PMT CORPORATION
2102-06-147
In Commercial Distribution

  • 00650551150701 ()


  • Depth electrode

DEPTHALON - 00650551150695

PLATINUM, 6 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL, 0.8MM OD, 2MM CONTACT LENGTH, 37MM RECORDING DEPTH, 7MM SPACING, 27CM MAIN TUBE LENGTH
PMT CORPORATION
2102-06-146
In Commercial Distribution

  • 00650551150695 ()


  • Depth electrode

DEPTHALON - 00650551150626

PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL, 0.8MM OD, 2MM CONTACT LENGTH, 61.55MM RECORDING DEPTH, 3.97MM SPACING, 60CM MAIN TUBE LENGTH
PMT CORPORATION
2102-16-136
In Commercial Distribution

  • 00650551150626 ()


  • Depth electrode

DEPTHALON - 00650551150619

PLATINUM, 6 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL, 0.8MM OD, 2MM CONTACT LENGTH, 19.5MM RECORDING DEPTH, 3.5MM SPACING, 60CM MAIN TUBE LENGTH
PMT CORPORATION
2102-06-131
In Commercial Distribution

  • 00650551150619 ()


  • Depth electrode

SYNCHROMED®II - 00643169984226

PUMP 8637-40 SYNCHROMED II 40ML DLC US
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00643169984226 ()

  • Total Volume: 40.0 Milliliter


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED®II - 00643169984219

PUMP 8637-20 SYNCHROMED II 20ML DLC US
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00643169984219 ()

  • Total Volume: 20.0 Milliliter


  • Implantable intrathecal infusion pump, programmable

DEPTHALON® - 00650551045809

DEPTH ELECTRODE, PLATINUM, 8 CONTACT, MINI CONNECTOR, MEG 2
PMT CORPORATION
2102-08-IL-SS-M2
In Commercial Distribution

  • 00650551045809 ()

  • Recording Depth 37 Millimeter
  • Spacing 5 Millimeter
  • Main Tube Length 32 Centimeter
  • Contact Length 2 Millimeter
2102-08-IL-SS-M2

  • Depth electrode

DEPTHALON® - 00650551045793

DEPTH ELECTRODE, PLATINUM, 4 CONTACT, MINI CONNECTOR, MEG 2
PMT CORPORATION
2102-04-IL-SS-M2
In Commercial Distribution

  • 00650551045793 ()

  • Recording Depth 44 Millimeter
  • Spacing 10 Millimeter
  • Main Tube Length 32 Centimeter
  • Contact Length 5 Millimeter
2102-04-IL-SS-M2

  • Depth electrode

DEPTHALON® - 00650551045786

DEPTH ELECTRODE, PLATINUM, 6 CONTACT, MINI CONNECTOR, MEG 2
PMT CORPORATION
2102-06-IL-SS-M2
In Commercial Distribution

  • 00650551045786 ()

  • Contact Length 5 Millimeter
  • Main Tube Length 32 Centimeter
  • Spacing 10 Millimeter
  • Recording Depth 55 Millimeter
2102-06-IL-SS-M2

  • Depth electrode

DEPTHALON® - 00650551041993

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-108
In Commercial Distribution

  • 00650551041993 ()

  • Spacing 3.5 Millimeter
  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 90 Millimeter
2102-16-108

  • Depth electrode

DEPTHALON® - 00650551041986

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-098
In Commercial Distribution

  • 00650551041986 ()

  • Spacing 3.5 Millimeter
  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 90 Millimeter
2102-16-098

  • Depth electrode
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