Company Name Brand Name GMDN Term 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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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
CryoTip
FUJIFILM IRVINE SCIENTIFIC, INC.
40709-Pack
In Commercial Distribution

  • 00893727002118 ()
  • 10893727002115 ()
40709

  • Assisted reproduction cryotube
microTargeting™ Platform Platinum 6X Non Sterile
FHC, INC.
45335Z-00799
In Commercial Distribution

  • 10873263007997 ()
  • 00873263007990 ()

  • Length: 212.72 Millimeter
  • Impedance: Megaohms
  • Length: 3 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 220.72 Millimeter
45335Z

  • Depth electrode
microTargeting™ Platform 6X Non Sterile
FHC, INC.
44335Z-00797
In Commercial Distribution

  • 10873263007973 ()
  • 00873263007976 ()

  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
  • Length: 212.72 Millimeter
  • Length: 220.72 Millimeter
  • Length: 3 Millimeter
44335Z

  • Depth electrode
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™ Frame Single Tungsten 6X Non Sterile
FHC, INC.
34325Z-00793
In Commercial Distribution

  • 10873263007935 ()
  • 00873263007938 ()

  • Length: 263.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 3 Millimeter
  • Length: 271.4 Millimeter
  • Impedance: Megaohms
34325Z

  • Depth electrode
microTargeting™ Array Frame Platinum 6X Non Sterile
FHC, INC.
25335Z-00791
In Commercial Distribution

  • 10873263007911 ()
  • 00873263007914 ()

  • Outer Diameter: 0.56 Millimeter
  • Length: 276.5 Millimeter
  • Length: 3 Millimeter
  • Length: 268.5 Millimeter
  • Impedance: Megaohms
25335Z

  • Depth electrode
microTargeting™ Array Electrodes 6x Non Sterile
FHC, INC.
22335Z-00789
In Commercial Distribution

  • 10873263007898 ()
  • 00873263007891 ()

  • Length: 3 Millimeter
  • Length: 276.5 Millimeter
  • Length: 268.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
22335Z

  • Depth electrode
microTargeting STar Array Electrode and Insertion Tube Kit, 5x, for use with Stereotactic Frame and STar Drive. Contains: IT(AR16): Insertion Tube. IT(AR17): Insertion Tube w/ Stylet. MTDWLN(AR)(AR2): microTargeting Electrode. 66-CN-ET: Insertion Tube Extractor. Individual Specifications: IT(AR16) - 135mm tube length, 1.981mm OD, 0.96mm ID. IT(AR17) - 243.5mm tube length, 0.902mm OD, 0.597mm ID, 264mm stylet length (includes collar). MTDWLN(AR)(AR2) - 276.5mm electrode length, 10mm differential, 261.5mm protective tube length, 0.55mm OD. DZAP(L) 1 Meg
FHC, INC.
KTF1002-00758
In Commercial Distribution

  • 10873263007584 ()
  • 00873263007587 ()
KTF1002

  • Intracerebral cannula, nonimplantable, single-use
  • Depth electrode
Array Insertion Electrode/Tube with Stylet Kit, 5x, Sterile, for use with Nexframe and microTargeting Drive. Contains: IT(AR8): Insertion Tube w/ Stylet. MTDPBN(PA)(DB2): microTargeting Electrode. Individual Specifications: IT(AR8) - 217mm tube length, 0.89mm OD, 0.58mm ID MTDPBN(PA)(DB2) - 249.2mm electrode length, 10mm differential length, 234.2mm protective tube length. 1 Meg RZAP, 0.56mm od
FHC, INC.
FC7100-00756
In Commercial Distribution

  • 10873263007560 ()
  • 00873263007563 ()
FC7100

  • Depth electrode
  • Intracerebral cannula, nonimplantable, single-use
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 D.ZAP Electrode Kit, 5x, Sterile, Single, 1 Meg, for use with NexFrame and NexDrive or mT Drive. Each box contains: 2x MTDPLN(PA)(DB2) D.ZAP Differential Electrode. 1x IT(DB3) Insertion tube with Stylet. 1x PT(DB5) Protective Tube. Individual Specifications: MTDPLN(PA)(DB2) - 249.2mm electrode length, 10mm tip exposure, 234.2mm protective tube length, .56mm od, 1.0 meg DZAP(L) IT(DB3) - 194mm length, 1.8mm od, 1.6mm id, PT(DB5) - 194mm length, 1.47mm od, 0.99mm id
FHC, INC.
FC4001-00754
In Commercial Distribution

  • 10873263007546 ()
  • 00873263007549 ()
FC4001

  • Depth electrode
  • Intracerebral cannula, nonimplantable, single-use
microTargeting single electrode insertion tubes and electrodes kit, 5x, Sterile for use with NexFrame and NexDrive or mT Drive. Each Box Contains: 2x MTDPBN(PA)(DB2) Electrode. 1x IT(DB3) Insertion Tube with Stylet. 1x PT(DB5) Spacer Tube. Individual Specifications: MTDPBN(PA)(DB2) - 249.2mm electrode length, 10mm tip expsure, 234.3mm protective tube length, 0.56mm od, 1.0 meg. RZAP IT(DB3) - 194mm length, 1.8mm od, 1.6mm id. PT(DB5) - 194mm length, 1.47mm od, 0.99mm id.
FHC, INC.
FC4000-00753
In Commercial Distribution

  • 10873263007539 ()
  • 00873263007532 ()
FC4000

  • Intracerebral cannula, nonimplantable, single-use
  • Depth electrode
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 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 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 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 5x, non-sterile, Array, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC1003-00748
In Commercial Distribution

  • 10873263007485 ()
  • 00873263007488 ()

  • Length: 10 Millimeter
  • Length: 276.5 Millimeter
  • Length: 261.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
FC1003

  • Depth electrode
microTargeting Electrode 5x, non-sterile, Single, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC1002-00747
In Commercial Distribution

  • 10873263007478 ()
  • 00873263007471 ()

  • Outer Diameter: 0.77 Millimeter
  • Length: 10 Millimeter
  • Length: 256.4 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
FC1002

  • Depth electrode
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 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™ Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWXN(AR)(MP1)-00744
In Commercial Distribution

  • 10873263007447 ()
  • 00873263007440 ()

  • Lumen/Inner Diameter: 0.55 Millimeter
  • Length: 220.72 Millimeter
  • Length: 205.72 Millimeter
  • Length: 10 Millimeter
MTDWXN(AR)(MP1)

  • Depth electrode
microTargeting™ Electrode, differential, tungsten, D.ZAP(L), nonsterile
FHC, INC.
MTDWLN(BP)(BP7)-00743
In Commercial Distribution

  • 10873263007430 ()
  • 00873263007433 ()

  • Length: 271.4 Millimeter
  • Length: 256.4 Millimeter
  • Length: 10 Millimeter
  • Lumen/Inner Diameter: 0.77 Millimeter
  • Impedance: Megaohms
MTDWLN(BP)(BP7)

  • Depth electrode
microTargeting Electrode, differential, tungsten, non-sterile
FHC, INC.
MTDWBN(AR)(DB1)-00742
In Commercial Distribution

  • 10873263007423 ()
  • 00873263007426 ()

  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
  • Length: 234.22 Millimeter
  • Length: 249.22 Millimeter
  • Length: 10 Millimeter
MTDWBN(AR)(DB1)

  • Depth electrode
microTargeting(TM) Electrode, 6x, differential, tungsten, DZAP(Z), nonsterile
FHC, INC.
MTDWLN(AR)(DU1)-00707
In Commercial Distribution

  • 10873263007072 ()
  • 00873263007075 ()

  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 271.5 Millimeter
  • Length: 286.5 Millimeter
MTDWLN(AR)(DU1)

  • Depth electrode
microTargeting(TM) Electrode, 6x, differential, tungsten, DZAP(Z), nonsterile
FHC, INC.
MTDWZN(AR)(DU1)-00706
In Commercial Distribution

  • 10873263007065 ()
  • 00873263007068 ()

  • Length: 271.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
  • Length: 286.5 Millimeter
  • Impedance: Megaohms
MTDWZN(AR)(DU1)

  • Depth electrode
microTargeting(TM) Electrode, Back loaded, Platinum/Iridium with Glass Insulation
FHC, INC.
MTBPBN(DT1)-00671
In Commercial Distribution

  • 10873263006716 ()
  • 00873263006719 ()

  • Length: 300 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.63 Millimeter
MTBPBN(DT1)

  • Depth electrode
microTargeting Electrode, differential, 5mm ext, tungsten, non-sterile
FHC, INC.
MTDWBN(SP)(BW1)-00670
In Commercial Distribution

  • 10873263006709 ()
  • 00873263006702 ()

  • Length: 5 Millimeter
  • Length: 266.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
MTDWBN(SP)(BW1)

  • Depth electrode
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