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(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
microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(NS)(SK2)-00462
In Commercial Distribution

  • 10873263004620 ()
  • 00873263004623 ()

  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 243.65 Millimeter
  • Length: 227 Millimeter
MTDWZP(NS)(SK2)

  • Depth electrode
CryoTip
FUJIFILM IRVINE SCIENTIFIC, INC.
40709-Pack
In Commercial Distribution

  • 00893727002118 ()
  • 10893727002115 ()
40709

  • Assisted reproduction cryotube
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
D630 to D670 DR NM GANTRY UPGRADE KIT
G E MEDICAL SYSTEMS ISRAEL LTD.
H3101RS
In Commercial Distribution

  • 00195278794772 ()
5953035

  • Stationary gamma camera system
  • Full-body CT system
870 DR NM GANTRY FINAL WITH NEW ROTOR - MDR CE
G E MEDICAL SYSTEMS ISRAEL LTD.
870 DR
In Commercial Distribution

  • 00195278788269 ()


  • Stationary gamma camera system
  • Full-body CT system
830 NM GANTRY FINAL WITH NEW ROTOR - MDR CE
G E MEDICAL SYSTEMS ISRAEL LTD.
830
In Commercial Distribution

  • 00195278788252 ()
5376204-33

  • Stationary gamma camera system
MyoSPECT ES to MyoSPECT Upgrade kit
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BS
In Commercial Distribution

  • 00195278722546 ()
5941445

  • Stationary gamma camera system
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