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, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(BP)(B10)-00456
In Commercial Distribution

  • 10873263004569 ()
  • 00873263004562 ()

  • Length: 261.4 Millimeter
  • Length: 271.4 Millimeter
  • Impedance: Megaohms
  • Length: 5 Millimeter
  • Outer Diameter: 0.77 Millimeter
MTDWZP(BP)(B10)

  • Depth electrode
microTargeting Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(BP)(BP5)-00454
In Commercial Distribution

  • 10873263004545 ()
  • 00873263004548 ()

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

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(AR)(MP3)-00452
Not in Commercial Distribution

  • 10873263004521 ()
  • 00873263004524 ()

  • Length: 5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 220.72 Millimeter
  • Length: 210.72 Millimeter
  • Impedance: Megaohms
MTDWZP(AR)(MP3)

  • Depth electrode
microTargeting(TM) Electrode, 5x, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(AR)(DB1)-00450
In Commercial Distribution

  • 10873263004507 ()
  • 00873263004500 ()

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

  • Depth electrode
microTargeting(TM) Electrode, 5x, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(AO)(AO9)-00448
In Commercial Distribution

  • 10873263004484 ()
  • 00873263004487 ()

  • Impedance: Megaohms
  • Length: 241.86 Millimeter
  • Length: 233.86 Millimeter
  • Length: 3 Millimeter
  • Outer Diameter: 1.27 Millimeter
MTDWZP(AO)(AO9)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, sterile, DZAP(L)
FHC, INC.
MTDWLP(BP)(BP8)-00400
In Commercial Distribution

  • 10873263004002 ()
  • 00873263004005 ()

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

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, D.ZAP(L), sterile
FHC, INC.
MTDWLP(BP)(BP6)-00398
In Commercial Distribution

  • 10873263003982 ()
  • 00873263003985 ()

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

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, sterile
FHC, INC.
MTDWBP(SB)(SB2)-00390
In Commercial Distribution

  • 10873263003906 ()
  • 00873263003909 ()

  • Length: 260 Millimeter
  • Impedance: Megaohms
  • Length: 6 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 272.65 Millimeter
MTDWBP(SB)(SB2)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, sterile
FHC, INC.
MTDWBP(LS)(LS3)-00388
In Commercial Distribution

  • 10873263003883 ()
  • 00873263003886 ()

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

  • Depth electrode
microTargeting(TM) Electrode, backloaded, tungsten, sterile
FHC, INC.
MTBWAP(JJ2)-00309
In Commercial Distribution

  • 10873263003098 ()
  • 00873263003091 ()

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

  • Depth electrode
microTargeting(TM) Electrode, sterile, D.ZAP(Z), for Nexframe(R) and STar(R) Drive
FHC, INC.
5705Z-00289
In Commercial Distribution

  • 10873263002893 ()
  • 00873263002896 ()

  • Outer Diameter: 0.56 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Length: 227.2 Millimeter
  • Length: 242.2 Millimeter
5705Z

  • Depth electrode
microTargeting(TM) Electrode, sterile, D.ZAP(L), for use with Nexframe(R) and STar Drive
FHC, INC.
5705L-00283
In Commercial Distribution

  • 10873263002831 ()
  • 00873263002834 ()

  • Length: 227.2 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 242.2 Millimeter
  • Impedance: Megaohms
5705L

  • Depth electrode
microTargeting(TM) Electrode, sterile, D.ZAP(Z), for use with Nexframe(R)
FHC, INC.
5005Z-00277
In Commercial Distribution

  • 10873263002770 ()
  • 00873263002773 ()

  • Impedance: Megaohms
  • Length: 234.2 Millimeter
  • Length: 10 Millimeter
  • Length: 249.2 Millimeter
  • Outer Diameter: 0.56 Millimeter
5005Z

  • Depth electrode
microTargeting(TM) Electrode, sterile, D.ZAP(L), for use with Nexframe(R)
FHC, INC.
5005L-00273
In Commercial Distribution

  • 10873263002732 ()
  • 00873263002735 ()

  • Length: 249.2 Millimeter
  • Length: 10 Millimeter
  • Length: 234.2 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
5005L

  • Depth electrode
microTargeting(TM) Electrode, sterile, D.Zap(Z), for use with Platform
FHC, INC.
44975Z-00267
In Commercial Distribution

  • 10873263002671 ()
  • 00873263002674 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 205.72 Millimeter
  • Length: 10 Millimeter
  • Length: 220.72 Millimeter
44975Z

  • Depth electrode
microTargeting(TM) Electrode, sterile, D.ZAP(L), for use with Platform
FHC, INC.
44975L-00263
In Commercial Distribution

  • 10873263002633 ()
  • 00873263002636 ()

  • Impedance: Megaohms
  • Length: 220.72 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
  • Length: 205.72 Millimeter
44975L

  • Depth electrode
microTargeting(TM) Electrode, 1x, sterile, R.ZAP, Platform
FHC, INC.
44970R-00259
In Commercial Distribution

  • 10873263002596 ()
  • 00873263002599 ()

  • Length: 205.72 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 220.72 Millimeter
  • Length: 10 Millimeter
44970R

  • Depth electrode
microTargeting LP+ Patient Lead, Sterile, for use with microTargting Electrodes
FHC, INC.
66-EL-LP-00258
In Commercial Distribution

  • 00873263002582 ()
66-EL-LP

  • Depth electrode
microTargeting Electrode Cable w/ Alligator Clips, Sterile, for use with microTargeting Electrodes
FHC, INC.
66-EL-EC-01-00257
In Commercial Distribution

  • 00873263002575 ()
66-EL-EC-01

  • Depth electrode
microTargeting(TM) Electrode, 1x, sterile, single, D.ZAP(Z), T=30 for use with Frame and STar or MT Drive
FHC, INC.
34685Z-00254
In Commercial Distribution

  • 10873263002541 ()
  • 00873263002544 ()

  • Length: 256.4 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
34685Z

  • Depth electrode
microTargeting(TM) Electrode, sterile, single, D.ZAP(L), T=30 for use with Frame and STar or MT Drive
FHC, INC.
34685L-00252
In Commercial Distribution

  • 10873263002527 ()
  • 00873263002520 ()

  • Length: 256.4 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
34685L

  • Depth electrode
microTargeting(TM) Electrode, differential, sterile, single, 1 Meg for use with Frame and STar or MT Drive
FHC, INC.
34680R-00250
In Commercial Distribution

  • 10873263002503 ()
  • 00873263002506 ()

  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 256.4 Millimeter
  • Length: 271.4 Millimeter
34680R

  • Depth electrode
microTargeting(TM) Electrode, sterile, 1x, array, D.ZAP(Z) for use with Frame and STar or MT Drive
FHC, INC.
22675Z-00246
In Commercial Distribution

  • 10873263002466 ()
  • 00873263002469 ()

  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
  • Length: 261.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
22675Z

  • Depth electrode
microTargeting Array Electrode, 1x, sterile, D.ZAP(L) for use with Frame, STar or MT Drive
FHC, INC.
22675L-00244
In Commercial Distribution

  • 10873263002442 ()
  • 00873263002445 ()

  • Impedance: Megaohms
  • Length: 261.5 Millimeter
  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
22675L

  • Depth electrode
microTargeting Array Electrode, sterile, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
22670R-00242
In Commercial Distribution

  • 10873263002428 ()
  • 00873263002421 ()

  • Impedance: Megaohms
  • Length: 261.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
22670R

  • Depth electrode
microTargeting Electrode Cable, Sterile, for use with microTargeting Electrodes
FHC, INC.
66-EL-EC-00155
In Commercial Distribution

  • 00873263001554 ()
66-EL-EC

  • Depth electrode
microTargeting Electrode Cable
FHC, INC.
FC1020-00151
In Commercial Distribution

  • 00873263001516 ()
FC1020

  • Depth electrode
microTargeting Electrode Cable
FHC, INC.
FC1020-00139
In Commercial Distribution

  • 00873263001394 ()
FC1020

  • Depth electrode
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-027
In Commercial Distribution

  • 09348215081423 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-168
In Commercial Distribution

  • 09348215055967 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-166
In Commercial Distribution

  • 09348215055950 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-164
In Commercial Distribution

  • 09348215055936 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-163
In Commercial Distribution

  • 09348215055929 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-162
In Commercial Distribution

  • 09348215055912 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-161
In Commercial Distribution

  • 09348215055905 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-160
In Commercial Distribution

  • 09348215055899 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-159
In Commercial Distribution

  • 09348215055882 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-158
In Commercial Distribution

  • 09348215055875 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-024
In Commercial Distribution

  • 09348215055790 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-023
In Commercial Distribution

  • 09348215055783 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-170
In Commercial Distribution

  • 09348215055974 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-165
In Commercial Distribution

  • 09348215055943 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
101-139
In Commercial Distribution

  • 09348215055356 ()


  • Orthopaedic broach
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003034 ()
203511 SD

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003027 ()

  • Length: 30 Millimeter
  • Length: 35 Millimeter
  • Length: 40 Millimeter
  • Length: 45 Millimeter
  • Length: 50 Millimeter
  • Length: 55 Millimeter
  • Length: 60 Millimeter
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man203511

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003003 ()
203511 SD

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003002 ()

  • Length: 60 Millimeter
  • Length: 55 Millimeter
  • Length: 50 Millimeter
  • Length: 45 Millimeter
  • Length: 40 Millimeter
  • Length: 35 Millimeter
  • Length: 30 Millimeter
203511

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003146 ()
203511-60

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003139 ()
203511-55

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003122 ()
203511-50

  • Intraurethral valve/pump
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