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 ground tip, nonsterile
FHC, INC.
MTDWXN(BS)(OC3)-00536
In Commercial Distribution

  • 10873263005368 ()
  • 00873263005361 ()

  • Length: 1 Millimeter
  • Length: 293 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 286 Millimeter
MTDWXN(BS)(OC3)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, D.ZAP(L), nonsterile
FHC, INC.
MTDWLN(BS)(FM2)-00534
In Commercial Distribution

  • 10873263005344 ()
  • 00873263005347 ()

  • Outer Diameter: 0.77 Millimeter
  • Length: 2 Millimeter
  • Length: 93 Millimeter
  • Length: 100 Millimeter
  • Impedance: Megaohms
MTDWLN(BS)(FM2)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWXN(BS)(OC2)-00409
In Commercial Distribution

  • 10873263004095 ()
  • 00873263004098 ()

  • Length: 2 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 293 Millimeter
  • Length: 286 Millimeter
MTDWXN(BS)(OC2)

  • Depth electrode
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(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
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
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
Rod, MIS, Lordotic 5.5X60mm. 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-01-060
In Commercial Distribution

  • 00814008029655 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 60 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X110mm. 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-850-110
In Commercial Distribution

  • 00814008029587 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 110 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X95mm. 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-850-095
In Commercial Distribution

  • 00814008029556 ()

  • Length: 95 Millimeter
  • Outer Diameter: 8.5 Millimeter


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