microTargeting™ Electrode, back loaded, non sterile, platinum/iridium
FHC, INC.
MTBPLN(KB1)-00657
In Commercial Distribution

  • 10873263006570 ()
  • 00873263006573 ()

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

  • 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, 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, 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™ 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(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
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
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
SET OF 10 ANCHOR BOLTS, LENGTH 35MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539000695 ()
  • 03664539003313 ()

  • Length: 35 Millimeter
ACS-035SMS-10

  • Depth electrode
SET OF 10 ANCHOR BOLTS, LENGTH 30MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539000688 ()
  • 03664539003306 ()

  • Length: 30 Millimeter
ACS-030SMS-10

  • Depth electrode
PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X35mm. 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-850-035
In Commercial Distribution

  • 00814008029433 ()

  • Length: 35 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X30mm. 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-850-030
In Commercial Distribution

  • 00814008029426 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 30 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X35mm. 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-750-035
In Commercial Distribution

  • 00814008029358 ()

  • Length: 35 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X30mm. 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-750-030
In Commercial Distribution

  • 00814008029341 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 30 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Cortical Cancellous 8.5X35mm. 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-850-035
In Commercial Distribution

  • 00814008028931 ()

  • Length: 35 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Cortical Cancellous 8.5X30mm. 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-850-030
In Commercial Distribution

  • 00814008028924 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 30 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Cortical Cancellous 5.5X35mm. 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-550-035
In Commercial Distribution

  • 00814008028696 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Cortical Cancellous 4.75X35mm. 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-475-035
In Commercial Distribution

  • 00814008028610 ()

  • Length: 35 Millimeter
  • Outer Diameter: 4.75 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 5.5X35mm. 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-550-035
In Commercial Distribution

  • 00814008028191 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 5.5X30mm. 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-550-030
In Commercial Distribution

  • 00814008028184 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 30 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 4.75X35mm. 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-475-035
In Commercial Distribution

  • 00814008028115 ()

  • Length: 35 Millimeter
  • Outer Diameter: 4.75 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 4.75X30mm. 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-475-030
In Commercial Distribution

  • 00814008028108 ()

  • Outer Diameter: 4.75 Millimeter
  • Length: 30 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 8.5X35mm. 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-850-035
In Commercial Distribution

  • 00814008027934 ()

  • Length: 35 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 8.5X30mm. 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-850-030
In Commercial Distribution

  • 00814008027927 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 30 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, Lordotic 5.5X35mm. 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-01-035
In Commercial Distribution

  • 00814008027255 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 35 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, Lordotic 5.5X30mm. 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-01-030
In Commercial Distribution

  • 00814008027248 ()

  • Length: 30 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower, Cannulated Dual Lead 8.5X35mm. 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-850-035
In Commercial Distribution

  • 00814008026906 ()

  • Length: 35 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower, Cannulated Dual Lead 8.5X30mm. 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-850-030
In Commercial Distribution

  • 00814008026890 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 30 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, MIS, Lordotic 5.5X35mm. 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-01-035
In Commercial Distribution

  • 00814008029600 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter


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