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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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
MyoSPECT ES MDR GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BD
In Commercial Distribution

  • 00195278488626 ()
5875815-40

  • Stationary gamma camera system
MyoSPECT MDR GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BC
In Commercial Distribution

  • 00195278488619 ()
5875815-30

  • Stationary gamma camera system
MyoSPECT GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912AA
In Commercial Distribution

  • 00195278421586 ()
5875815-10

  • Stationary gamma camera system
MyoSPECT ES GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912AB
In Commercial Distribution

  • 00195278421579 ()
5875815-20

  • Stationary gamma camera system
STARGATE NM GANTRY FINAL
G E MEDICAL SYSTEMS ISRAEL LTD.
H3911AB
In Commercial Distribution

  • 00195278118295 ()


  • Stationary gamma camera system
  • Full-body CT system
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 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, differential, Platinum/Iridium, nonsterile
FHC, INC.
MTDPZN(PA)(MP1)-00641
In Commercial Distribution

  • 10873263006419 ()
  • 00873263006412 ()

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

  • Depth electrode
microTargeting(TM) Electrode, differential, Platinum/Iridium, nonsterile
FHC, INC.
MTDPLN(PA)(MP1)-00639
In Commercial Distribution

  • 10873263006396 ()
  • 00873263006399 ()

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

  • Depth electrode
microTargeting(TM) Electrode, differential, Platinum/Iridium, nonsterile
FHC, INC.
MTDPBN(PS)(PS1)-00632
In Commercial Distribution

  • 10873263006327 ()
  • 00873263006320 ()

  • Length: 271.4 Millimeter
  • Length: 256.4 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Outer Diameter: 0.86 Millimeter
MTDPBN(PS)(PS1)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(BP)(BP8)-00582
In Commercial Distribution

  • 10873263005825 ()
  • 00873263005828 ()

  • Length: 3 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 271.4 Millimeter
  • Length: 263.4 Millimeter
  • Impedance: Megaohms
MTDWBN(BP)(BP8)

  • Depth electrode
microTargeting(TM) Electrode, 6x, non-sterile, D.ZAP(Z), for use with Nexframe(R) and STar Drive
FHC, INC.
5735Z-00581
In Commercial Distribution

  • 10873263005818 ()
  • 00873263005811 ()

  • Outer Diameter: 0.56 Millimeter
  • Length: 242.2 Millimeter
  • Length: 227.2 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
5735Z

  • Depth electrode
microTargeting(TM) Electrode, 6x, non-sterile, D.ZAP(L), for use with Nexframe(R) and STar Drive
FHC, INC.
5735L-00580
In Commercial Distribution

  • 10873263005801 ()
  • 00873263005804 ()

  • Length: 242.2 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 227.2 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
5735L

  • Depth electrode
microTargeting(TM) Electrode, 6x, non-sterile, for use with Nexframe(R) and STar Drive
FHC, INC.
5730R-00579
In Commercial Distribution

  • 10873263005795 ()
  • 00873263005798 ()

  • Outer Diameter: 0.56 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Length: 242.2 Millimeter
  • Length: 227.2 Millimeter
5730R

  • Depth electrode
microTargeting(TM) Electrode, non-sterile, DZAP(Z), for use with Nexframe(R)
FHC, INC.
5035Z-00577
In Commercial Distribution

  • 10873263005771 ()
  • 00873263005774 ()

  • Length: 10 Millimeter
  • Length: 249.2 Millimeter
  • Length: 234.2 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
5035Z

  • Depth electrode
microTargeting(TM) Electrode, non-sterile, DZAP(L), for use with Nexframe(R)
FHC, INC.
5035L-00576
In Commercial Distribution

  • 10873263005764 ()
  • 00873263005767 ()

  • Length: 234.2 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 10 Millimeter
  • Length: 249.2 Millimeter
5035L

  • Depth electrode
microTargeting(TM) Electrode, non-sterile, for use with Nexframe(R)
FHC, INC.
5030R-00575
In Commercial Distribution

  • 10873263005757 ()
  • 00873263005750 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 10 Millimeter
  • Length: 249.2 Millimeter
  • Length: 234.2 Millimeter
5030R

  • Depth electrode
microTargeting(TM) Electrode, 6x, non-sterile, single, D.ZAP(L), for use with Platform
FHC, INC.
44935L-00573
In Commercial Distribution

  • 10873263005733 ()
  • 00873263005736 ()

  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 205.7 Millimeter
  • Length: 220.7 Millimeter
  • Outer Diameter: 0.55 Millimeter
44935L

  • Depth electrode
microTargeting(TM) Electrode, 6x, non-sterile, single, for use with Platform
FHC, INC.
44930R-00572
In Commercial Distribution

  • 10873263005726 ()
  • 00873263005729 ()

  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
  • Length: 220.7 Millimeter
  • Length: 205.7 Millimeter
44930R

  • Depth electrode
microTargeting(TM) Electrode, non-sterile, single, T=30, for use with Frame and STar or MT Drive
FHC, INC.
34620R-00571
In Commercial Distribution

  • 10873263005719 ()
  • 00873263005712 ()

  • Length: 256.4 Millimeter
  • Length: 10 Millimeter
  • Length: 271.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
34620R

  • Depth electrode
microTargeting(TM) Electrode, differential, nonsterile
FHC, INC.
MTDPXN(EP)(BP8)-00570
In Commercial Distribution

  • 10873263005702 ()
  • 00873263005705 ()

  • Length: 271.4 Millimeter
  • Length: 263.4 Millimeter
  • Outer Diameter: 0.86 Millimeter
  • Length: 3 Millimeter
MTDPXN(EP)(BP8)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten ground tip, nonsterile
FHC, INC.
MTDWXN(BS)(OC4)-00557
In Commercial Distribution

  • 10873263005573 ()
  • 00873263005576 ()

  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 1 Millimeter
  • Length: 270.5 Millimeter
MTDWXN(BS)(OC4)

  • Depth electrode
microTargeting D.ZAP(L) Differential Electrode 5x, Sterile, Single, T=30 for use with Frame and STar or MT Drive
FHC, INC.
FC2002-00127
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 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, differential, tungsten, 6x,D.ZAP(L), nonsterile
FHC, INC.
MTDWLN(BP)(BP6)-00868
In Commercial Distribution

  • 00873263008683 ()
  • 10873263008680 ()
MTDWLN(BP)(BP6)

  • Depth electrode
microTargeting™ Electrode, non sterile, 6x, Array, D.ZAP(Z), T=30 for use with frame, STar or MT Drive
FHC, INC.
MTDWZN(AR)(AR7)-00863
In Commercial Distribution

  • 00873263008638 ()
  • 10873263008635 ()
MTDWZN(AR)(AR7)

  • Depth electrode
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
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