Company Name Brand Name GMDN Term 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, shielded, tungsten, nonsterile, 6x
FHC, INC.
MTSWBN(LX1)-00488
In Commercial Distribution

  • 10873263004880 ()
  • 00873263004883 ()

  • Outer Diameter: 1.24 Millimeter
  • Impedance: Megaohms
  • Length: 50 Millimeter
  • Length: 193 Millimeter
  • Length: 49 Millimeter
  • Length: 246 Millimeter
MTSWBN(LX1)

  • Depth electrode
microTargeting(TM) Electrode, shielded, platinum, DZAP(L), nonsterile, 6x
FHC, INC.
MTSPLN(RD1)-00486
In Commercial Distribution

  • 10873263004866 ()
  • 00873263004869 ()

  • Length: 216 Millimeter
  • Length: 163 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 1.24 Millimeter
  • Length: 50 Millimeter
  • Length: 49 Millimeter
MTSPLN(RD1)

  • Depth electrode
microTargeting(TM) Electrode, shielded, platinum, non-sterile, 6x
FHC, INC.
MTSPBN(LX1)-00482
In Commercial Distribution

  • 10873263004828 ()
  • 00873263004821 ()

  • Length: 193 Millimeter
  • Length: 50 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 1.24 Millimeter
  • Length: 49 Millimeter
  • Length: 246 Millimeter
MTSPBN(LX1)

  • Depth electrode
microTargeting(TM) Electrode, shielded, platinum, nonsterile, 6x
FHC, INC.
MTSPAN(RD1)-00475
In Commercial Distribution

  • 10873263004750 ()
  • 00873263004753 ()

  • Length: 163 Millimeter
  • Impedance: Megaohms
  • Length: 49 Millimeter
  • Length: 216 Millimeter
  • Length: 50 Millimeter
  • Outer Diameter: 1.245 Millimeter
MTSPAN(RD1)

  • Depth electrode
microTargeting(TM) Electrode, differential, platinum/iridium, glass insulated, specify Z, nonsterile
FHC, INC.
MTDPXN(SP)(AO9)-00335
In Commercial Distribution

  • 10873263003357 ()
  • 00873263003350 ()

  • Length: 1 Millimeter
  • Length: 235.86 Millimeter
  • Length: 241.86 Millimeter
  • Outer Diameter: 1.24 Millimeter
MTDPXN(SP)(AO9)

  • Depth electrode
microTargeting(TM) Electrode, back loaded, non sterile, Platinum/Iridium, glass insulated
FHC, INC.
MTBPBN(EN2)-00297
In Commercial Distribution

  • 10873263002978 ()
  • 00873263002971 ()

  • Outer Diameter: 0.63 Millimeter
  • Length: 50 Millimeter
  • Length: 300 Millimeter
  • Impedance: Megaohms
MTBPBN(EN2)

  • Depth electrode
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(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(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
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
PS, MIS-Extend, Cannulated Dual Lead 7.5X50mm. 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-750-050
In Commercial Distribution

  • 00814008028382 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 6.5X50mm. 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-650-050
In Commercial Distribution

  • 00814008028306 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 5.5X50mm. 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-550-050
In Commercial Distribution

  • 00814008028221 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 4.75X50mm. 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-475-050
In Commercial Distribution

  • 00814008028146 ()

  • Outer Diameter: 4.75 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 8.5X50mm. 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-850-050
In Commercial Distribution

  • 00814008027965 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 7.5X50mm. 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-750-050
In Commercial Distribution

  • 00814008027880 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 6.5X50mm. 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-650-050
In Commercial Distribution

  • 00814008027804 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 5.5X50mm. 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-550-050
In Commercial Distribution

  • 00814008027729 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Cortical Cancellous 4.75X50mm. 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-475-050
In Commercial Distribution

  • 00814008027644 ()

  • Outer Diameter: 4.75 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, Straight 5.5X50mm. 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-01-050
In Commercial Distribution

  • 00814008027453 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, Lordotic 5.5X50mm. 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-01-050
In Commercial Distribution

  • 00814008027309 ()

  • Length: 50 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower, Cannulated Cortical Cancellous 8.5X50mm. 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-850-050
In Commercial Distribution

  • 00814008027118 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower, Cannulated Dual Lead 8.5X50mm. 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-850-050
In Commercial Distribution

  • 00814008026937 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower, Cannulated Cortical Cancellous 7.5X50mm. 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-750-050
In Commercial Distribution

  • 00814008026852 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower, Cannulated Dual Lead 7.5X50mm. 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-750-050
In Commercial Distribution

  • 00814008026777 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower, Cannulated Cortical Cancellous 6.5X50mm. 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-650-050
In Commercial Distribution

  • 00814008026692 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower, Cannulated Dual Lead 6.5X50mm. 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-650-050
In Commercial Distribution

  • 00814008026616 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower, Cannulated Cortical Cancellous 5.5X50mm. 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-550-050
In Commercial Distribution

  • 00814008026548 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower, Cannulated Dual Lead 5.5X50mm. 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-550-050
In Commercial Distribution

  • 00814008026463 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 50 Millimeter


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