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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™ Electrode - 00873263007969

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™ Electrode - 00873263007945

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™ Electrode - 00873263006726

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 - 00873263006696

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™ Electrode - 00873263006610

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™ Electrode - 00873263006597

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 - 00873263006511

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™ Electrode - 00873263006429

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™ Electrode - 00873263006405

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™ Electrode - 00873263005781

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™ Electrode - 00873263005743

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™ Electrode - 00873263005422

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™ Electrode - 00873263005385

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 - 00873263005194

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™ Electrode - 00873263005040

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™ Electrode - 00873263004920

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™ Electrode - 00873263004906

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™ Electrode - 00873263004722

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 - 00873263004661

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™ Electrode - 00873263004647

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™ Electrode - 00873263004623

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

microTargeting™ Differential Electrode - 10873263007072

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™ Differential Electrode - 10873263007065

microTargeting(TM) Electrode, 6x, differential, tungsten, DZAP(Z), nonsterile
FHC, INC.
MTDWZN(AR)(DU1)-00706
In Commercial Distribution

  • 10873263007065 ()
  • 00873263007068 ()

  • Length: 271.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
  • Length: 286.5 Millimeter
  • Impedance: Megaohms
MTDWZN(AR)(DU1)

  • Depth electrode

microTargeting™ Array Electrode - 10873263007911

microTargeting™ Array Frame Platinum 6X Non Sterile
FHC, INC.
25335Z-00791
In Commercial Distribution

  • 10873263007911 ()
  • 00873263007914 ()

  • Outer Diameter: 0.56 Millimeter
  • Length: 276.5 Millimeter
  • Length: 3 Millimeter
  • Length: 268.5 Millimeter
  • Impedance: Megaohms
25335Z

  • Depth electrode

microTargeting™ Array Electrode - 10873263007898

microTargeting™ Array Electrodes 6x Non Sterile
FHC, INC.
22335Z-00789
In Commercial Distribution

  • 10873263007898 ()
  • 00873263007891 ()

  • Length: 3 Millimeter
  • Length: 276.5 Millimeter
  • Length: 268.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
22335Z

  • Depth electrode

microTargeting™ Array Electrode - 00873263002469

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 - 00873263007921

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 Electrode - 00873263007907

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

inFlow Sizing Device - 00862563003078

Urethral measurement device, female.
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003078 ()
203511-SD

  • Intraurethral valve/pump

inFlow Intraurethral Valve-Pump - 08625630003034

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

  • 08625630003034 ()
203511 SD

  • Intraurethral valve/pump

inFlow Intraurethral Valve-Pump - 08625630003027

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

inFlow Intraurethral Valve-Pump - 08625630003003

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

  • 08625630003003 ()
203511 SD

  • Intraurethral valve/pump

inFlow Intraurethral Valve-Pump - 08625630003002

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

inFlow Device - 00862563003146

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003146 ()
203511-60

  • Intraurethral valve/pump

inFlow Device - 00862563003139

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003139 ()
203511-55

  • Intraurethral valve/pump

inFlow Device - 00862563003122

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003122 ()
203511-50

  • Intraurethral valve/pump

inFlow Device - 00862563003115

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003115 ()
203511-45

  • Intraurethral valve/pump

inFlow Device - 00862563003108

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003108 ()
203511-40

  • Intraurethral valve/pump

inFlow Device - 00862563003092

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003092 ()
203511-35

  • Intraurethral valve/pump

inFlow Device - 00862563003085

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003085 ()
203511-30

  • Intraurethral valve/pump

icotec Lumbar Cage, Implant Holder for Tamping - 07640164841830

icotec Lumbar Cage, Implant Holder for Tamping
icotec AG
38-036
In Commercial Distribution

  • 07640164841830 ()
38-036

  • Bone graft packing block

easypod - 04054839025860

easypod is an electromechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rDNA origin]) in cartridges.
EMD SERONO, INC.
U1222102
Not in Commercial Distribution

  • 04054839025860 ()


  • Empty self-injector, electronic

ePlex System - 00857167005030

ePlex Respiratory Panel Kit, 12 test, IVD
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005030 ()
EA001012

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex

ePlex System - 00857167005023

ePlex Sample Delivery Device RP Panel
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005023 ()
KT022006

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex

ePlex System - 00857167005016

Respiratory Panel Cartridge
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005016 ()
KT022287

  • Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

c.cam Imaging System - 04056869001272

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08419009
In Commercial Distribution

  • 04056869001272 ()
8419009..

  • Stationary gamma camera system

Zuma-L - 10889981097783

Graft Packing Block, 18mm
SEASPINE ORTHOPEDICS CORPORATION
95-6091
In Commercial Distribution

  • 10889981097783 ()

  • 18mm
95-6091

  • Bone graft packing block

Zuma-C - 10889981120733

Zuma-C Universal Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
95-7092
In Commercial Distribution

  • 10889981120733 ()

  • N/A
95-7092

  • Bone graft packing block

Zuma-C - 10889981100223

Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
95-7091
In Commercial Distribution

  • 10889981100223 ()

  • N/A
95-7091

  • Bone graft packing block

Zuma - 10889981120627

Graft Packing Block, 38mm x 26mm
SEASPINE ORTHOPEDICS CORPORATION
95-5193
In Commercial Distribution

  • 10889981120627 ()

  • 38mm x 26mm
95-5193

  • Bone graft packing block
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