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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 - 00873263008003

microTargeting™ Platform Platinum 5X Sterile
FHC, INC.
45375Z-00800
In Commercial Distribution

  • 10873263008000 ()
  • 00873263008003 ()

  • Outer Diameter: 0.56 Millimeter
  • Impedance: Megaohms
  • Length: 220.72 Millimeter
  • Length: 212.72 Millimeter
  • Length: 3 Millimeter
45375Z

  • Depth electrode

microTargeting™ Electrode - 00873263007983

microTargeting™ Platform Electrodes 5x Sterile
FHC, INC.
44375Z-00798
In Commercial Distribution

  • 10873263007980 ()
  • 00873263007983 ()

  • Length: 3 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 212.72 Millimeter
  • Length: 220.72 Millimeter
44375Z

  • Depth electrode

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™ 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

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 - 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

FOCUS - 00814008029709

Rod, MIS, Lordotic 5.5X100mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
M-01-100
In Commercial Distribution

  • 00814008029709 ()

  • Length: 100 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

FOCUS - 00814008029563

PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X100mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDR-850-100
In Commercial Distribution

  • 00814008029563 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 100 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

FOCUS - 00814008028061

PS, MIS-Extend, Cannulated Cortical Cancellous 8.5X100mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCM-850-100
In Commercial Distribution

  • 00814008028061 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 100 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

FOCUS - 00814008027521

Rod, Straight 5.5X100mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
S-01-100
In Commercial Distribution

  • 00814008027521 ()

  • Length: 100 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

FOCUS - 00814008027033

PS, MIS-Tower, Cannulated Dual Lead 8.5X100mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-850-100
In Commercial Distribution

  • 00814008027033 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 100 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

FOCUS - 00814008029068

PS, MIS-Tower Reduction, Cannulated Cortical Cancellous 8.5X100mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCR-850-100
In Commercial Distribution

  • 00814008029068 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 100 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

FOCUS - 00814008028566

PS, MIS-Extend, Cannulated Dual Lead 8.5X100mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-850-100
In Commercial Distribution

  • 00814008028566 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 100 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

FOCUS - 00814008027354

Rod, Lordotic 5.5X100mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
L-01-100
In Commercial Distribution

  • 00814008027354 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 100 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

FOCUS - 00814008027217

PS, MIS-Tower, Cannulated Cortical Cancellous 8.5X100mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDC-850-100
In Commercial Distribution

  • 00814008027217 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 100 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
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