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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microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWXN(BS)(OC2)-00409
In Commercial Distribution

  • 10873263004095 ()
  • 00873263004098 ()

  • Length: 2 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 293 Millimeter
  • Length: 286 Millimeter
MTDWXN(BS)(OC2)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWXN(BP)(BP7)-00406
In Commercial Distribution

  • 10873263004064 ()
  • 00873263004067 ()

  • Outer Diameter: 0.77 Millimeter
  • Length: 10 Millimeter
  • Length: 256.4 Millimeter
  • Length: 271.4 Millimeter
MTDWXN(BP)(BP7)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWXN(AR)(AR2)-00404
In Commercial Distribution

  • 10873263004040 ()
  • 00873263004043 ()

  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
  • Length: 261.5 Millimeter
  • Length: 10 Millimeter
MTDWXN(AR)(AR2)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, D.ZAP(L), nonsterile
FHC, INC.
MTDWLN(BP)(BP8)-00396
In Commercial Distribution

  • 10873263003968 ()
  • 00873263003961 ()

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

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, D.ZAP(L)
FHC, INC.
MTDWLN(AR)(AR1)-00394
Not in Commercial Distribution

  • 10873263003944 ()
  • 00873263003947 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 3 Millimeter
  • Length: 268.5 Millimeter
  • Length: 276.5 Millimeter
MTDWLN(AR)(AR1)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWCN(AR)(AR2)-00392
In Commercial Distribution

  • 10873263003920 ()
  • 00873263003923 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
  • Length: 261.5 Millimeter
MTDWCN(AR)(AR2)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(LS)(LS3)-00386
In Commercial Distribution

  • 10873263003869 ()
  • 00873263003862 ()

  • Length: 291.5 Millimeter
  • Length: 273.5 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
MTDWBN(LS)(LS3)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(BP)(BP7)-00384
In Commercial Distribution

  • 10873263003845 ()
  • 00873263003848 ()

  • Length: 256.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Length: 10 Millimeter
MTDWBN(BP)(BP7)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, non sterile
FHC, INC.
MTDWBN(BP)(BP6)-00382
In Commercial Distribution

  • 10873263003821 ()
  • 00873263003824 ()

  • Length: 227 Millimeter
  • Length: 277 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.77 Millimeter
  • Length: 10 Millimeter
MTDWBN(BP)(BP6)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(BP)(BP5)-00380
In Commercial Distribution

  • 10873263003807 ()
  • 00873263003800 ()

  • Length: 215 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 265 Millimeter
  • Outer Diameter: 0.77 Millimeter
MTDWBN(BP)(BP5)

  • Depth electrode
microTargeting Electrode, differential, tungsten, non-sterile
FHC, INC.
MTDWBN(AR)(AR2)-00375
In Commercial Distribution

  • 10873263003753 ()
  • 00873263003756 ()

  • Length: 261.5 Millimeter
  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
MTDWBN(AR)(AR2)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(AO)(AO1)-00372
In Commercial Distribution

  • 10873263003722 ()
  • 00873263003725 ()

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

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(AO)(A10)-00363
In Commercial Distribution

  • 10873263003630 ()
  • 00873263003633 ()

  • Length: 242 Millimeter
  • Length: 210 Millimeter
  • Outer Diameter: 1.27 Millimeter
  • Length: 27 Millimeter
  • Impedance: Megaohms
MTDWBN(AO)(A10)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWAN(AR)(AR1)-00360
Not in Commercial Distribution

  • 10873263003609 ()
  • 00873263003602 ()

  • Impedance: Megaohms
  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 3 Millimeter
  • Length: 268.5 Millimeter
MTDWAN(AR)(AR1)

  • Depth electrode
microTargeting(TM) Electrode, differential, platinum/iridium, glass insulated DZAP(Z), non-sterile
FHC, INC.
MTDPZN(BP)(BP7)-00343
In Commercial Distribution

  • 10873263003432 ()
  • 00873263003435 ()

  • Length: 271.4 Millimeter
  • Length: 256.4 Millimeter
  • Outer Diameter: 0.86 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
MTDPZN(BP)(BP7)

  • Depth electrode
microTargeting(TM) Electrode, differential, platinum/iridium, glass insulated, specify Z, nonsterile
FHC, INC.
MTDPXN(SP)(AO9)-00335
In Commercial Distribution

  • 10873263003357 ()
  • 00873263003350 ()

  • Length: 1 Millimeter
  • Length: 235.86 Millimeter
  • Length: 241.86 Millimeter
  • Outer Diameter: 1.24 Millimeter
MTDPXN(SP)(AO9)

  • Depth electrode
microTargeting(TM) Electrode, differential, platinum/iridium, glass insulated, specify Z, nonsterile
FHC, INC.
MTDPXN(BP)(BP7)-00330
In Commercial Distribution

  • 10873263003302 ()
  • 00873263003305 ()

  • Length: 256.4 Millimeter
  • Length: 271.4 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.86 Millimeter
MTDPXN(BP)(BP7)

  • Depth electrode
microTargeting Electrode, differential, platinum/iridium, DZAP(L), epoxylite insulated, nonsterile
FHC, INC.
MTDPLN(PA)(DB2)-00329
In Commercial Distribution

  • 10873263003296 ()
  • 00873263003299 ()

  • Length: 234.2 Millimeter
  • Length: 249.2 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 10 Millimeter
MTDPLN(PA)(DB2)

  • Depth electrode
microTargeting(TM) Electrode, differential, nonsterile
FHC, INC.
MTDPBN(PA)(DB2)-00315
In Commercial Distribution

  • 10873263003159 ()
  • 00873263003152 ()

  • Outer Diameter: 0.56 Millimeter
  • Length: 249.2 Millimeter
  • Length: 10 Millimeter
  • Length: 234.2 Millimeter
  • Impedance: Megaohms
MTDPBN(PA)(DB2)

  • Depth electrode
microTargeting(TM) Electrode, backloaded, tungsten, nonsterile
FHC, INC.
MTBWBN(WH1)-00312
In Commercial Distribution

  • 10873263003128 ()
  • 00873263003121 ()

  • Length: 305 Millimeter
  • Impedance: Megaohms
  • Length: 35 Millimeter
  • Outer Diameter: 0.34 Millimeter
MTBWBN(WH1)

  • Depth electrode
microTargeting(TM) Electrode, backloaded, tungsten, nonsterile
FHC, INC.
MTBWAN(JJ2)-00308
In Commercial Distribution

  • 10873263003081 ()
  • 00873263003084 ()

  • Length: 285 Millimeter
  • Length: 15 Millimeter
  • Outer Diameter: 0.34 Millimeter
  • Impedance: Megaohms
MTBWAN(JJ2)

  • Depth electrode
microTargeting(TM) electrode, back loaded, non sterile, specify impedance, platinum/iridium, glass insulated
FHC, INC.
MTBPXN(EN3)-00307
In Commercial Distribution

  • 10873263003074 ()
  • 00873263003077 ()

  • Length: 40 Millimeter
  • Length: 280 Millimeter
  • Outer Diameter: 0.63 Millimeter
MTBPXN(EN3)

  • Depth electrode
microTargeting(TM) Electrode, back loaded, non sterile, platinum/iridium, glass insulated
FHC, INC.
MTBPBN(KB1)-00302
In Commercial Distribution

  • 10873263003029 ()
  • 00873263003022 ()

  • Length: 30 Millimeter
  • Length: 305 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.63 Millimeter
MTBPBN(KB1)

  • Depth electrode
microTargeting(TM) Electrode, back loaded, non sterile, Platinum/Iridium, glass insulated
FHC, INC.
MTBPBN(EN2)-00297
In Commercial Distribution

  • 10873263002978 ()
  • 00873263002971 ()

  • Outer Diameter: 0.63 Millimeter
  • Length: 50 Millimeter
  • Length: 300 Millimeter
  • Impedance: Megaohms
MTBPBN(EN2)

  • Depth electrode
microTargeting(TM) Electrode, Back loaded, Platinum/Iridium with Glass Insulation
FHC, INC.
MTBPBN(AZ1)-00291
In Commercial Distribution

  • 10873263002916 ()
  • 00873263002919 ()

  • Outer Diameter: 0.63 Millimeter
  • Length: 35 Millimeter
  • Impedance: Megaohms
  • Length: 260 Millimeter
MTBPBN(AZ1)

  • Depth electrode
microTargeting(TM) Electrode, 6x, non-sterile, D.ZAP(Z), Platform
FHC, INC.
44935Z-00256
In Commercial Distribution

  • 10873263002565 ()
  • 00873263002568 ()

  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 220.72 Millimeter
  • Length: 205.72 Millimeter
44935Z

  • Depth electrode
microTargeting(TM) Electrode, non-sterile, single, D.ZAP(Z) T=30, for use with Frame and STar or MT Drive
FHC, INC.
34625Z-00249
In Commercial Distribution

  • 10873263002497 ()
  • 00873263002490 ()

  • Outer Diameter: 0.77 Millimeter
  • Length: 256.4 Millimeter
  • Length: 271.4 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
34625Z

  • Depth electrode
microTargeting(TM) Electrode, non-sterile, single, DZAP(L) T=30, for use with Frame and STar or MT Drive
FHC, INC.
34625L-00248
In Commercial Distribution

  • 10873263002480 ()
  • 00873263002483 ()

  • Length: 256.4 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 271.4 Millimeter
  • Impedance: Megaohms
34625L

  • Depth electrode
microTargeting(TM) Electrode, non sterile, 6x, Array, D.ZAP(Z), T=30 for use with frame, STar or MT Drive
FHC, INC.
22635Z-00241
In Commercial Distribution

  • 10873263002411 ()
  • 00873263002414 ()

  • Impedance: Megaohms
  • Length: 261.5 Millimeter
  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
22635Z

  • Depth electrode
microTargeting(TM) Electrode, non-sterile, 6x, array, D.ZAP(L), T=30 for use with frame, STar or MT Drive
FHC, INC.
22635L-00240
In Commercial Distribution

  • 10873263002404 ()
  • 00873263002407 ()

  • Impedance: Megaohms
  • Length: 261.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
22635L

  • Depth electrode
microTargeting(TM) Electrode, 6x, non-sterile, Array, 1 Meg, T=30 for use with frame and STar or mT drive
FHC, INC.
22630R-00239
In Commercial Distribution

  • 10873263002398 ()
  • 00873263002391 ()

  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 261.5 Millimeter
  • Impedance: Megaohms
22630R

  • Depth electrode
microTargeting Electrode 6x, non-sterile, Array, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC1003-00136
In Commercial Distribution

  • 10873263001360 ()
  • 00873263001363 ()

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

  • Depth electrode
microTargeting Electrode 6x, non-sterile, Single, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC1002-00135
In Commercial Distribution

  • 10873263001353 ()
  • 00873263001356 ()

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

  • 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.
KTF1002-00134
In Commercial Distribution

  • 10873263001346 ()
  • 00873263001349 ()
KTF1002

  • Intracerebral cannula, implantable
  • 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.
FC7100-00132
In Commercial Distribution

  • 10873263001322 ()
  • 00873263001325 ()
FC7100

  • Intracerebral cannula, implantable
  • Depth electrode
microTargeting Differential Electrodes 5x, Sterile, Single and Array, DZAP(L), T=30 for use with Nexframe and STar Drive
FHC, INC.
FC2004-00129
In Commercial Distribution

  • 10873263001292 ()
  • 00873263001295 ()

  • Length: 227.2 Millimeter
  • Length: 242.2 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 10 Millimeter
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.
FC2003-00128
In Commercial Distribution

  • 10873263001285 ()
  • 00873263001288 ()

  • Length: 249.2 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 234.2 Millimeter
  • Length: 10 Millimeter
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.
FC2002-00127
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
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
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
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
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
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.
FC4001-00116
In Commercial Distribution

  • 10873263001162 ()
  • 00873263001165 ()
FC4001

  • Depth electrode
  • Intracerebral cannula, implantable
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.
FC4000-00115
In Commercial Distribution

  • 10873263001155 ()
  • 00873263001158 ()
FC4000

  • Depth electrode
  • Intracerebral cannula, implantable
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
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906ER
In Commercial Distribution

  • 00840682146401 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906EF
In Commercial Distribution

  • 00840682145947 ()


  • Stationary gamma camera system
  • Full-body CT system
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