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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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)
AU10D5L25
Not in Commercial Distribution

  • M272AU10D5L251 ()
  • 10381780036104 ()

  • 10 platinum contacts


  • Depth electrode
No Description
Hertart ApS
16106
In Commercial Distribution

  • 27350025914606 ()
  • 17350025914609 ()
  • 07350025914602 ()


  • Assisted reproduction centrifuge tube
No Description
Hertart ApS
16105
In Commercial Distribution

  • 27350025914590 ()
  • 17350025914593 ()
  • 07350025914596 ()


  • Assisted reproduction centrifuge tube
No Description
Hertart ApS
16103
In Commercial Distribution

  • 17350025914579 ()
  • 27350025914576 ()
  • 07350025914572 ()


  • Assisted reproduction centrifuge tube
No Description
Hertart ApS
16101
In Commercial Distribution

  • 07350025914558 ()
  • 17350025914555 ()
  • 27350025914552 ()


  • Assisted reproduction centrifuge tube
CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 5 x 6 cm
Helios Cardio Inc.
CMUS-05NS-0506
In Commercial Distribution

  • 00850023375087 ()

  • Length: 5 Centimeter
  • Width: 6 Centimeter
  • Height: 0.5 Millimeter
CMUS-05NS-0506

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 7 x 15 cm
Helios Cardio Inc.
CMUS-10NS-0715
In Commercial Distribution

  • 00850023375070 ()

  • Width: 15 Centimeter
  • Height: 1.0 Millimeter
  • Length: 7 Centimeter
CMUS-10NS-0715

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 12 cm
Helios Cardio Inc.
CMUS-10NS-0812
In Commercial Distribution

  • 00850023375063 ()

  • Length: 8 Centimeter
  • Width: 12 Centimeter
  • Height: 1.0 Millimeter
CMUS-10NS-0812

  • Cardiovascular patch, animal-derived
CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 4 x 7 cm
Helios Cardio Inc.
CMUS-05NS-0407
In Commercial Distribution

  • 00850023375056 ()

  • Length: 4 Centimeter
  • Width: 7 Centimeter
  • Height: 0.5 Millimeter
CMUS-05NS-0407

  • Cardiovascular patch, animal-derived
CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 8 x 12 cm
Helios Cardio Inc.
CMUS-05NS-0812
In Commercial Distribution

  • 00850023375049 ()

  • Length: 8 Centimeter
  • Width: 12 Centimeter
  • Height: 0.5 Millimeter
CMUS-05NS-0812

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 10 x 15 cm
Helios Cardio Inc.
CMUS-10NS-1015
In Commercial Distribution

  • 00850023375032 ()

  • Length: 10 Centimeter
  • Width: 15 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-1015

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 5 x 6 cm
Helios Cardio Inc.
CMUS-10NS-0506
In Commercial Distribution

  • 00850023375025 ()

  • Length: 5 Centimeter
  • Width: 6 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-0506

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 16 cm
Helios Cardio Inc.
CMUS-10NS-0816
In Commercial Distribution

  • 00850023375018 ()

  • Length: 8 Centimeter
  • Width: 16 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-0816

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 6 x 12 cm
Helios Cardio Inc.
CMUS-10NS-0612
In Commercial Distribution

  • 00850023375001 ()

  • Length: 6 Centimeter
  • Width: 12 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-0612

  • Cardiovascular patch, animal-derived
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™ Electrode, tungsten, sterile, D.ZAP(Z)
FHC, INC.
MTDWZP(AO)(A11)-00921
In Commercial Distribution

  • 10873263009212 ()
  • 00873263009215 ()
MTDWZP(AO)(A11)

  • Depth electrode
microTargeting™ Electrodes, differential, tungsten, sterile, LZAP
FHC, INC.
MTDWLP(SP)(MP4)-00915
In Commercial Distribution

  • 10873263009151 ()
  • 00873263009154 ()
MTDWLP(SP)(MP4)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(AR)(AR7)-00865
In Commercial Distribution

  • 00873263008652 ()
  • 10873263008659 ()
MTDWZP(AR)(AR7)

  • Depth electrode
microTargeting™ Platform Platinum 5X Sterile
FHC, INC.
45375Z-00800
In Commercial Distribution

  • 10873263008000 ()
  • 00873263008003 ()

  • Outer Diameter: 0.56 Millimeter
  • Impedance: Megaohms
  • Length: 220.72 Millimeter
  • Length: 212.72 Millimeter
  • Length: 3 Millimeter
45375Z

  • Depth electrode
microTargeting™ Platform Electrodes 5x Sterile
FHC, INC.
44375Z-00798
In Commercial Distribution

  • 10873263007980 ()
  • 00873263007983 ()

  • Length: 3 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 212.72 Millimeter
  • Length: 220.72 Millimeter
44375Z

  • Depth electrode
microTargeting™ Single Frame Platinum 5X Sterile
FHC, INC.
35385Z-00796
In Commercial Distribution

  • 10873263007966 ()
  • 00873263007969 ()

  • Length: 3 Millimeter
  • Length: 263.4 Millimeter
  • Outer Diameter: 0.86 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
35385Z

  • Depth electrode
microTargeting™ Frame Single Tungsten 5X Sterile
FHC, INC.
34385Z-00794
In Commercial Distribution

  • 10873263007942 ()
  • 00873263007945 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.77 Millimeter
  • Length: 263.4 Millimeter
  • Length: 3 Millimeter
  • Length: 271.4 Millimeter
34385Z

  • Depth electrode
microTargeting™ Array Frame Platinum 5X Sterile
FHC, INC.
25375Z-00792
In Commercial Distribution

  • 10873263007928 ()
  • 00873263007921 ()

  • Length: 3 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 276.5 Millimeter
  • Length: 268.5 Millimeter
25375Z

  • Depth electrode
microTargeting™ Array Electrodes 5x Sterile
FHC, INC.
22375Z-00790
In Commercial Distribution

  • 10873263007904 ()
  • 00873263007907 ()

  • Length: 268.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 3 Millimeter
  • Length: 276.5 Millimeter
22375Z

  • Depth electrode
Guidline 4000 ™ 5.0 1.5m Special-use Lead, 1x For use with microTargeting ™ Electrodes
FHC, INC.
C0232-00781
In Commercial Distribution

  • 00873263007815 ()

  • Length: 1.5 Meter
C0232

  • Depth electrode
microTargeting Single Procedure Kit, with microElectrode, tubes, sterile drape sleeve and cable. Contains: IT(BP2): Insertion Tube. 2x MTDWLN(BP)(BP7): microTargeting Electrode. PT(BP2): Protective Tube. Sterile Drape Sleeve for microTargeting motor FC1020 Electrode Lead Individual Specifications: IT(BP2) - 183mm tube length, 1.829mm OD, 1.6mm ID, 184mm stylet (not including collar). MTDWLN(BP)(BP7) - 271.4mm electrode length, 10mm differential, 256.4mm protective tube length, 0.77mm OD. 1Meg DZAP(L) PT(PB2) - 181mm tube length, 1.47mm OD, 0.99mm ID OD: 0.77mm
FHC, INC.
KTF1001-00757
In Commercial Distribution

  • 00873263007570 ()
KTF1001

  • Depth electrode
  • Patient surgical drape, single-use
  • Intracerebral cannula, nonimplantable, single-use
GL5 UE Patient Lead, 1.5m, presterile
FHC, INC.
C0231-00691
In Commercial Distribution

  • 00873263006917 ()

  • Length: 1.5 Meter
C0231

  • Depth electrode
GL5 UE Patient Lead, 3m, presterile
FHC, INC.
C0230-00690
In Commercial Distribution

  • 00873263006900 ()
C0230

  • Depth electrode
microTargeting(TM) Electrode, Back loaded, Platinum/Iridium with Glass Insulation, Presterile
FHC, INC.
MTBPBP(DT1)-00672
In Commercial Distribution

  • 10873263006723 ()
  • 00873263006726 ()

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

  • Depth electrode
microTargeting™ Electrode, back loaded, presterile, tungsten
FHC, INC.
MTBWLP(ZK1)-00669
In Commercial Distribution

  • 10873263006693 ()
  • 00873263006696 ()

  • Outer Diameter: 0.34 Millimeter
  • Length: 2 Millimeter
  • Length: 250 Millimeter
MTBWLP(ZK1)

  • Depth electrode
microTargeting™ Electrodes, differential, tungsten, sterile, DZAP
FHC, INC.
MTDWZP(SS)(BP8)-00661
In Commercial Distribution

  • 10873263006617 ()
  • 00873263006610 ()

  • Length: 263.4 Millimeter
  • Outer Diameter: 0.7 Millimeter
  • Length: 268.4 Millimeter
  • Impedance: Megaohms
  • Length: 3 Millimeter
MTDWZP(SS)(BP8)

  • Depth electrode
microTargeting™ Electrodes, differential, tungsten, sterile, LZAP
FHC, INC.
MTDWLP(SS)(BP8)-00659
In Commercial Distribution

  • 10873263006594 ()
  • 00873263006597 ()

  • Outer Diameter: 0.7 Millimeter
  • Length: 263.4 Millimeter
  • Length: 3 Millimeter
  • Length: 268.4 Millimeter
  • Impedance: Megaohms
MTDWLP(SS)(BP8)

  • Depth electrode
microTargeting™ Electrode, differential, sterile, platinum/iridium
FHC, INC.
MTDPZP(AO)(AO1)-00651
In Commercial Distribution

  • 10873263006518 ()
  • 00873263006511 ()

  • Length: 3 Millimeter
  • Outer Diameter: 1.24 Millimeter
  • Impedance: Megaohms
  • Length: 282 Millimeter
  • Length: 274 Millimeter
MTDPZP(AO)(AO1)

  • Depth electrode
microTargeting(TM) Electrode, sterile, D.ZAP(Z), for use with Platform
FHC, INC.
MTDPZP(PA)(MP1)-00642
In Commercial Distribution

  • 10873263006426 ()
  • 00873263006429 ()

  • Length: 215.72 Millimeter
  • Outer Diameter: 0.5 Millimeter
  • Length: 10 Millimeter
  • Length: 220.72 Millimeter
  • Impedance: Megaohms
MTDPZP(PA)(MP1)

  • Depth electrode
microTargeting(TM) Electrode, sterile, 5x, D.ZAP(L), for use with Platform
FHC, INC.
MTDPLP(PA)(MP1)-00640
In Commercial Distribution

  • 10873263006402 ()
  • 00873263006405 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.5 Millimeter
  • Length: 220.72 Millimeter
  • Length: 215.72 Millimeter
  • Length: 10 Millimeter
MTDPLP(PA)(MP1)

  • Depth electrode
microTargeting(TM) Electrode, sterile, for use with Nexframe(R) and STar Drive
FHC, INC.
5700R-00578
In Commercial Distribution

  • 10873263005788 ()
  • 00873263005781 ()

  • Outer Diameter: 0.56 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 242.2 Millimeter
  • Length: 227.2 Millimeter
5700R

  • Depth electrode
microTargeting(TM) Electrode, sterile, for use with Nexframe(R)
FHC, INC.
5000R-00574
In Commercial Distribution

  • 10873263005740 ()
  • 00873263005743 ()

  • Length: 10 Millimeter
  • Length: 249.2 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 234.2 Millimeter
  • Impedance: Megaohms
5000R

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, sterile
FHC, INC.
MTDWBP(AO)(AO1)-00542
In Commercial Distribution

  • 10873263005429 ()
  • 00873263005422 ()

  • Length: 3 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 1.27 Millimeter
  • Length: 274 Millimeter
  • Length: 282 Millimeter
MTDWBP(AO)(AO1)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, D.ZAP(L), sterile
FHC, INC.
MTDWLP(BS)(FM2)-00538
In Commercial Distribution

  • 10873263005382 ()
  • 00873263005385 ()

  • Length: 2 Millimeter
  • Length: 100 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.77 Millimeter
  • Length: 93 Millimeter
MTDWLP(BS)(FM2)

  • Depth electrode
microTargeting Electrode, side by side, tungsten, DZAP(L), sterile
FHC, INC.
MTTWLP(ZK2)-00519
In Commercial Distribution

  • 10873263005191 ()
  • 00873263005194 ()

  • Length: 252 Millimeter
  • Impedance: Megaohms
MTTWLP(ZK2)

  • Depth electrode
microTargeting Frame Kit D.ZAP/Lead Insertion, 1x, Sterile, for use with mT Drive or STar Drive. Contains: 34685L: Single D.ZAP Electrode. 66-DA-SD: Drape Sleeve. 66-EL-LP: Patient Lead for LP+. 66-IT-05P: Single Insertion Tube Set.
FHC, INC.
KT-FPK-S20-00508
In Commercial Distribution

  • 00873263005088 ()
KT-FPK-S20

  • Depth electrode
  • Neurological stereotactic surgery system
  • Intracerebral cannula, implantable
microTargeting(TM) Electrode, array, differential, 1 Meg, sterile, for Nexframe
FHC, INC.
MER-5000T-00504
In Commercial Distribution

  • 10873263005047 ()
  • 00873263005040 ()

  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 244.22 Millimeter
  • Length: 234.22 Millimeter
MER-5000T

  • Depth electrode
microTargeting(TM) Electrode, shielded, tungsten, DZAP(L), sterile
FHC, INC.
MTSWLP(JN)(JN1)-00492
In Commercial Distribution

  • 10873263004927 ()
  • 00873263004920 ()

  • Impedance: Megaohms
  • Length: 251.4 Millimeter
  • Length: 278.4 Millimeter
  • Length: 25 Millimeter
  • Outer Diameter: 0.77 Millimeter
MTSWLP(JN)(JN1)

  • Depth electrode
microTargeting(TM) Electrode, shielded, tungsten, sterile
FHC, INC.
MTSWBP(JN)(JN2)-00490
In Commercial Distribution

  • 10873263004903 ()
  • 00873263004906 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.77 Millimeter
  • Length: 16 Millimeter
  • Length: 288.4 Millimeter
  • Length: 270.4 Millimeter
MTSWBP(JN)(JN2)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(SP)(AR5)-00472
In Commercial Distribution

  • 10873263004729 ()
  • 00873263004722 ()

  • Length: 266.5 Millimeter
  • Length: 5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
MTDWZP(SP)(AR5)

  • Depth electrode
microTargeting Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(SP)(AR1)-00466
In Commercial Distribution

  • 10873263004668 ()
  • 00873263004661 ()

  • Length: 3 Millimeter
  • Length: 268.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
MTDWZP(SP)(AR1)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(NS)(SL2)-00464
In Commercial Distribution

  • 10873263004644 ()
  • 00873263004647 ()

  • Length: 10 Millimeter
  • Length: 274.65 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
  • Length: 258 Millimeter
MTDWZP(NS)(SL2)

  • Depth electrode
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