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, 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 Platform Procedure Consumables Kit, 1x, sterile, for use with mT or STar Drive, mT Platform and Guideline 4000 LP+. Contains: 44975L: D.ZAP Tungsten Differential Electrode - - 220.72mm electrode length, 10mm differential, 205.72mm protective tube length, DZAP(L) 1Meg, 0.55mm od. 66-DA-SD: Sterile Drape Sleeve for motor 66-EL-LP: Patient Lead for Guideline 4000 LP+ 66-IT-03P: Sterile Single Insertion Tube Set - IT(MP1) - 184.1mm tube length, 1.83mm od, 1.6mm id with Stylet PT(MP1) - Diameter reduction tube 0.58mm id
FHC, INC.
KT-PPK-S-00366
In Commercial Distribution

  • 00873263003664 ()
KT-PPK-S

  • Depth electrode
  • Patient surgical drape, single-use
  • Intracerebral cannula, implantable
microTargeting(TM) Electrode, differential, platinum/iridium, epoxylite insulated, sterile, D.ZAP(Z)
FHC, INC.
MTDPZP(NS)(SL2)-00358
In Commercial Distribution

  • 10873263003586 ()
  • 00873263003589 ()

  • Impedance: Megaohms
  • Length: 258 Millimeter
  • Length: 274.65 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 10 Millimeter
MTDPZP(NS)(SL2)

  • Depth electrode
microTargeting(TM) Electrode, differential, platinum/iridium, epoxylite insulated, sterile, D.ZAP(Z)
FHC, INC.
MTDPZP(EP)(BP8)-00348
In Commercial Distribution

  • 10873263003487 ()
  • 00873263003480 ()

  • Length: 263.4 Millimeter
  • Length: 3 Millimeter
  • Length: 271.4 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.86 Millimeter
MTDPZP(EP)(BP8)

  • Depth electrode
microTargeting(TM) Electrode, differential, platinum/iridium, epoxy insulated, sterile, D.ZAP(Z)
FHC, INC.
MTDPZP(EP)(BP7)-00345
In Commercial Distribution

  • 10873263003456 ()
  • 00873263003459 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.86 Millimeter
  • Length: 10 Millimeter
  • Length: 271.4 Millimeter
  • Length: 256.4 Millimeter
MTDPZP(EP)(BP7)

  • Depth electrode
microTargeting Electrode, differential, platinum/iridium, glass insulated, specify Z, sterile
FHC, INC.
MTDPXP(BP)(BP7)-00341
In Commercial Distribution

  • 10873263003418 ()
  • 00873263003411 ()

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

  • Depth electrode
microTargeting(TM) Electrode, differential, platinum/iridium, glass insulated, specify Z, sterile
FHC, INC.
MTDPXP(AO)(AO9)-00339
In Commercial Distribution

  • 10873263003395 ()
  • 00873263003398 ()

  • Length: 233.86 Millimeter
  • Length: 3 Millimeter
  • Length: 241.86 Millimeter
  • Outer Diameter: 1.24 Millimeter
MTDPXP(AO)(AO9)

  • Depth electrode
microTargeting(TM) Electrode, differential, sterile, platinum/iridium, glass insulated
FHC, INC.
MTDPBP(LS)(LS3)-00326
In Commercial Distribution

  • 10873263003265 ()
  • 00873263003268 ()

  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 291.5 Millimeter
  • Outer Diameter: 0.86 Millimeter
  • Length: 273.5 Millimeter
MTDPBP(LS)(LS3)

  • Depth electrode
microTargeting(TM) Electrode, differential, platinum/iridium, sterile
FHC, INC.
MTDPBP(BP)(BP7)-00325
In Commercial Distribution

  • 10873263003258 ()
  • 00873263003251 ()

  • Length: 3 Millimeter
  • Length: 263.4 Millimeter
  • Outer Diameter: 0.86 Millimeter
  • Length: 271.4 Millimeter
  • Impedance: Megaohms
MTDPBP(BP)(BP7)

  • Depth electrode
microTargeting(TM) Electrode, differential, sterile, platinum/iridium, glass insulated
FHC, INC.
MTDPBP(AO)(AO1)-00322
In Commercial Distribution

  • 10873263003227 ()
  • 00873263003220 ()

  • Impedance: Megaohms
  • Outer Diameter: 1.24 Millimeter
  • Length: 274 Millimeter
  • Length: 3 Millimeter
  • Length: 282 Millimeter
MTDPBP(AO)(AO1)

  • 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
microTargeting Single Procedure Kit, with microElectrode, tubes, sterile drape sleeve and cable. Contains: IT(BP2): Insertion Tube. 2x MTDWLN(BP)(BP7): microTargeting Electrode. PT(BP2): Protective Tube. Sterile Drape Sleeve for microTargeting motor FC1020 Electrode Lead Individual Specifications: IT(BP2) - 183mm tube length, 1.829mm OD, 1.6mm ID, 184mm stylet (not including collar). MTDWLN(BP)(BP7) - 271.4mm electrode length, 10mm differential, 256.4mm protective tube length, 0.77mm OD. 1Meg DZAP(L) PT(PB2) - 181mm tube length, 1.47mm OD, 0.99mm ID OD: 0.77mm
FHC, INC.
KTF1001-00133
Not in Commercial Distribution

  • 00873263001332 ()
KTF1001

  • Patient surgical drape, single-use
  • Intracerebral cannula, implantable
  • Depth electrode
microTargeting™ Electrode, tungsten, sterile, D.ZAP(Z)
FHC, INC.
MTDWZP(AO)(A11)-00921
In Commercial Distribution

  • 10873263009212 ()
  • 00873263009215 ()
MTDWZP(AO)(A11)

  • Depth electrode
microTargeting™ Electrode, tungsten, non sterile, 6x, D.ZAP(Z)
FHC, INC.
MTDWZN(AR)(MP7)-00920
In Commercial Distribution

  • 00873263009208 ()
  • 10873263009205 ()
MTDWZN(AR)(MP7)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(BP)(BP8)-00459
Not in Commercial Distribution

  • 10873263004590 ()
  • 00873263004593 ()

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

  • Depth electrode
Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP2X9
In Commercial Distribution

  • 00690103199048 ()

  • 2 CM X 9 CM
DP2X9

  • Cardiovascular patch, animal-derived
Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP1X6
In Commercial Distribution

  • 00690103199031 ()

  • 1 CM X 6 CM
DP1X6

  • Cardiovascular patch, animal-derived
Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP08X8
In Commercial Distribution

  • 00690103199024 ()

  • 0.8 CM X 8 CM
DP08X8

  • Cardiovascular patch, animal-derived
No Description
Edwards Lifesciences LLC
4700
In Commercial Distribution

  • 00690103144178 ()

  • 10 CENTIMETERS WIDE BY 15 CENTIMETERS LONG. USER WILL TAILOR TO DESIRED SIZE.
4700

  • Cardiovascular patch, animal-derived
EKSO BIONICS SYSTEM, Ekso NR
EKSO BIONICS, INC.
EKSONR
In Commercial Distribution

  • B168EKSONR0 ()
EKSONR

  • Programmable ambulation exoskeleton, clinical
EKSO BIONICS SYSTEM, Ekso GT
EKSO BIONICS, INC.
EKSOGT
In Commercial Distribution

  • B168EKSOGT0 ()
EKSOGT

  • Programmable ambulation exoskeleton, clinical
The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker.
EKSO BIONICS, INC.
GT
In Commercial Distribution

  • B1431200000 ()


  • Programmable ambulation exoskeleton, clinical
Indego Therapy is a computerized, adjustable-fit powered exoskeleton, designed to restore walking function for impaired individuals.
EKSO BIONICS, INC.
501-110-001
In Commercial Distribution

  • M704501110001 ()


  • Programmable ambulation exoskeleton, clinical
Indego is a computerized, powered exoskeleton, designed to restore walking function for impaired individuals.
EKSO BIONICS, INC.
501-100-000
In Commercial Distribution

  • M704501100000 ()


  • Programmable ambulation exoskeleton, clinical
In vitro diagnostic reagent for the quantitative determination of alpha2macroglobulin in samples of human origin (serum, heparinized plasma) by immunoturbidimetry on the cobas c systems.
Diagam
09029524190
In Commercial Distribution

  • 05415168006873 ()
09029524190

  • Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry
Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution

  • 05711665003033 ()

  • Weight: 2144 Kilogram
  • Height: 225 Centimeter
  • Depth: 197 Centimeter
  • Width: 291 Centimeter
9SYS2070

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
BodyMD Gamma Camera System
Not in Commercial Distribution

  • 05711665003026 ()

  • Width: 291 Centimeter
  • Depth: 197 Centimeter
  • Height: 225 Centimeter
  • Weight: 2144 Kilogram
9PMS3131

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution

  • 05711665003019 ()

  • Width: 291 Centimeter
  • Depth: 197 Centimeter
  • Height: 225 Centimeter
  • Weight: 2144 Kilogram
9PMS3131

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution

  • 05711665003002 ()

  • Weight: 2144 Kilogram
  • Height: 225 Centimeter
  • Depth: 197 Centimeter
  • Width: 291 Centimeter
9SYS2070

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
CardioMD Gamma Camera System
Not in Commercial Distribution

  • 05711665002029 ()

  • Width: 284 Centimeter
  • Depth: 150 Centimeter
  • Height: 150 Centimeter
  • Weight: 815 Kilogram
9PMS3060

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
CorCam Gamma Camera System
In Commercial Distribution

  • 05711665002012 ()

  • Width: 284 Centimeter
  • Depth: 150 Centimeter
  • Height: 150 Centimeter
  • Weight: 815 Kilogram
9PMS3060

  • Stationary gamma camera system
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