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 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 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 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(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
Refill Kit
Medos International Sàrl
91-4287
In Commercial Distribution

  • 10886704072072 ()
914287

  • Implantable intrathecal infusion pump, programmable
Refill Kit
Codman Neuro Sciences Sàrl
91-4285US
In Commercial Distribution

  • 20886704071454 ()
  • 10886704071457 ()
914285US

  • Implantable intrathecal infusion pump, programmable
Bolus Kit
Medos International Sàrl
91-4284US
In Commercial Distribution

  • 10886704071440 ()
914284US

  • Implantable intrathecal infusion pump, programmable
Refill Kit
Medos International Sàrl
91-4288
In Commercial Distribution

  • 20886704064951 ()
  • 10886704064954 ()
914288

  • Implantable intrathecal infusion pump, programmable
PUMP 8667-40 SYNCHROMEDIII INFUSION EMAN
MEDTRONIC, INC.
8667-40
In Commercial Distribution

  • 00763000597030 ()

  • Reservoir Volume 40 mL


  • Implantable intrathecal infusion pump, programmable
PUMP 8667-20 SYNCHROMEDIII INFUSION EMAN
MEDTRONIC, INC.
8667-20
In Commercial Distribution

  • 00763000597023 ()

  • Reservoir Volume 20 mL


  • Implantable intrathecal infusion pump, programmable
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
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
PUMP 8637-40 SM II 40ML EMAN SYMBL GRC
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00763000422615 ()


  • Implantable intrathecal infusion pump, programmable
PUMP 8637-20 SM II 20ML EMAN SYMBL GRC
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00763000422608 ()


  • Implantable intrathecal infusion pump, programmable
Prometra II 40ml Programmable Pump
Flowonix Medical, Inc.
16827
In Commercial Distribution

  • 00810335020242 ()


  • Implantable intrathecal infusion pump, programmable
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
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
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
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
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
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
PLATINUM DEPTH MICROWIRE ELECTRODE, 8 MACRO CONTACTS, 16 MICRO CONTACTS, MINI CONNECTOR, 1 EXIT, 3 LEAD
PMT CORPORATION
2104-08-16-006
In Commercial Distribution

  • 00650551148173 ()


  • Depth electrode
PLATINUM MICROWIRE ELECTRODE, 8 MACRO CONTACTS 8 MICRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2104-08-08-001
In Commercial Distribution

  • 00650551147947 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 14 MACRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-14-149
In Commercial Distribution

  • 00650551147657 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 12 MACRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-12-149
In Commercial Distribution

  • 00650551147640 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-173
In Commercial Distribution

  • 00650551147411 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-172
In Commercial Distribution

  • 00650551147404 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-171
In Commercial Distribution

  • 00650551147398 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-170
In Commercial Distribution

  • 00650551147381 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-169
In Commercial Distribution

  • 00650551147374 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-168
In Commercial Distribution

  • 00650551147367 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-167
In Commercial Distribution

  • 00650551147350 ()


  • Depth electrode
sEEG Depthalon Electrode, 16 macro contacts mini connector, 1 exit, 1, lead, 1 tail
PMT CORPORATION
2102-16-166
In Commercial Distribution

  • 00650551147343 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-165
In Commercial Distribution

  • 00650551147336 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-164
In Commercial Distribution

  • 00650551147329 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-163
In Commercial Distribution

  • 00650551147312 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-162
In Commercial Distribution

  • 00650551147305 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-161
In Commercial Distribution

  • 00650551147299 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-160
In Commercial Distribution

  • 00650551147282 ()


  • Depth electrode
STAINLESS STEEL ELECTRODE, 10 MICRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2104-00-10-004
In Commercial Distribution

  • 00650551147220 ()


  • Depth electrode
DEPTHALON MICROWIRE ELECTRODE, PLATINUM, 10 MICRO CONTACTS, INLINE CONNECTOR, 1 EXIT, 1 LEAD, 1 EXIT
PMT CORPORATION
2104-00-10-003
In Commercial Distribution

  • 00650551146742 ()


  • Depth electrode
DEPTHALON ELECTRODE, PLATINUM, 16 MACRO CONTACTS, 48 MICROWIRE CONTACTS, MINI CONNECTOR, 1 EXIT, 4 LEADS, 4 EXITS
PMT CORPORATION
2104-16-48-003
In Commercial Distribution

  • 00650551146629 ()


  • Depth electrode
Depthalon Electrode, Platinum, 7 Macro Contacts, 16 Microwire contacts, 52mm recording length, Mini connector, 1 exit, 4 leads, 4 exits
PMT CORPORATION
2104-07-057-003
In Commercial Distribution

  • 00650551144571 ()


  • Depth electrode
Depthalon Electrode, Platinum, 7 Macro Contacts, 57 Microwire contacts, 44mm recording length, Mini connector, 1 exit, 4 leads, 4 exits
PMT CORPORATION
2104-07-057-002
In Commercial Distribution

  • 00650551144564 ()


  • Depth electrode
Depthalon Electrode, Platinum, 8 Macro Contacts, 16 Microwire contacts, 38.5mm recording length, Miniconnector, 1 exit, 2 leads, 2 exits
PMT CORPORATION
2104-08-16-004
In Commercial Distribution

  • 00650551144465 ()


  • Depth electrode
Depthalon Electrode, Platinum, 8 Macro Contacts, 16 Microwire contacts, 38.5mm recording length, Inline connector, 1 exit, 2 leads, 2 exits
PMT CORPORATION
2104-08-16-003
In Commercial Distribution

  • 00650551144397 ()


  • Depth electrode
Depthalon sEEG Electrode, Platinum, 4 contacts, 17mm recording length, Mini connector, 1 Exit, 1 Lead, 1 Tail
PMT CORPORATION
2102-04-145
In Commercial Distribution

  • 00650551144380 ()


  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 57 MICROWIRE CONTACTS, MINI CONNECTOR
PMT CORPORATION
2104-07-57-001
In Commercial Distribution

  • 00650551143871 ()

  • Microwire Diameter 40 Micrometer
  • Main Tube Length 20 Centimeter
  • Contact Size 1.5 Millimeter
2104-07-57-001

  • Depth electrode
sEEG, PLATINUM, 14 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-14-146
In Commercial Distribution

  • 00650551143741 ()

  • Main Tube Length 27 Centimeter
  • Spacing 7 Millimeter
  • Recording Depth 93 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-14-146

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 48 MICROWIRE CONTACTS, MINI CONNECTOR
PMT CORPORATION
2104-07-48-001
In Commercial Distribution

  • 00650551143710 ()

  • Microwire Diameter 25 Micrometer
  • Main Tube Length 20 Centimeter
  • Contact Size 5 Millimeter
2104-07-48-001

  • Depth electrode
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