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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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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

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 - 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 - 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 - 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

Hemagard Carotid Patch - 00384401014966

Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK25/100CPUT (1)
In Commercial Distribution

  • 00384401014966 ()

  • Width: 25 Millimeter
  • Length: 100 Millimeter
HGK25/100CPUT (1)

  • Cardiovascular patch, animal-derived

Hemagard Patch - 00384401014867

Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK100/100P (1)
In Commercial Distribution

  • 00384401014867 ()

  • Width: 100 Millimeter
  • Length: 100 Millimeter
HGK100/100P (1)

  • Cardiovascular patch, animal-derived

Hemagard Patch - 00384401014836

Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK25/100P (1)
In Commercial Distribution

  • 00384401014836 ()

  • Width: 25 Millimeter
  • Length: 100 Millimeter
HGK25/100P (1)

  • Cardiovascular patch, animal-derived

Hemacarotid Patch - 00384401011248

Hemacarotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK25/100CPUT (1)
In Commercial Distribution

  • 00384401011248 ()

  • Length: 100 Millimeter
  • Width: 25 Millimeter
HEK25/100CPUT (1)

  • Cardiovascular patch, animal-derived

Hemapatch - 00384401001591

Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK25/100P (1)
In Commercial Distribution

  • 00384401001591 ()

  • Length: 100 Millimeter
  • Width: 25 Millimeter
HEK25/100P (1)

  • Cardiovascular patch, animal-derived

Hemapatch - 00384401001522

Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK100/100P (1)
In Commercial Distribution

  • 00384401001522 ()

  • Length: 100 Millimeter
  • Width: 100 Millimeter
HEK100/100P (1)

  • Cardiovascular patch, animal-derived

microTargeting™ Electrode - 10873263007478

microTargeting Electrode 5x, non-sterile, Single, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC1002-00747
In Commercial Distribution

  • 10873263007478 ()
  • 00873263007471 ()

  • Outer Diameter: 0.77 Millimeter
  • Length: 10 Millimeter
  • Length: 256.4 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
FC1002

  • Depth electrode

microTargeting™ Electrode - 10873263007461

microTargeting Differential Electrode 5x, Sterile, Single, 1 Meg, T=30 for use with frame, STar or MT Drive
FHC, INC.
34680-00746
In Commercial Distribution

  • 10873263007461 ()
  • 00873263007464 ()

  • Length: 256.4 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 10 Millimeter
34680

  • Depth electrode

microTargeting™ Electrode - 10873263005825

microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(BP)(BP8)-00582
In Commercial Distribution

  • 10873263005825 ()
  • 00873263005828 ()

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

  • Depth electrode

microTargeting™ Electrode - 10873263005719

microTargeting(TM) Electrode, non-sterile, single, T=30, for use with Frame and STar or MT Drive
FHC, INC.
34620R-00571
In Commercial Distribution

  • 10873263005719 ()
  • 00873263005712 ()

  • Length: 256.4 Millimeter
  • Length: 10 Millimeter
  • Length: 271.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
34620R

  • Depth electrode

microTargeting™ Electrode - 10873263001278

microTargeting D.ZAP(L) Differential Electrode 5x, Sterile, Single, T=30 for use with Frame and STar or MT Drive
FHC, INC.
FC2002-00127
Not in Commercial Distribution

  • 10873263001278 ()
  • 00873263001271 ()

  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Length: 271.4 Millimeter
  • Length: 256.4 Millimeter
FC2002

  • Depth electrode

microTargeting™ Electrode - 10873263007935

microTargeting™ Frame Single Tungsten 6X Non Sterile
FHC, INC.
34325Z-00793
In Commercial Distribution

  • 10873263007935 ()
  • 00873263007938 ()

  • Length: 263.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 3 Millimeter
  • Length: 271.4 Millimeter
  • Impedance: Megaohms
34325Z

  • Depth electrode

microTargeting™ Electrode - 10873263007508

microTargeting D.ZAP(L) Differential Electrode 5x, Sterile, Single, T=30 for use with Frame and STar or MT Drive
FHC, INC.
FC2002-00750
In Commercial Distribution

  • 10873263007508 ()
  • 00873263007501 ()

  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Length: 256.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
FC2002

  • Depth electrode

microTargeting™ Electrode - 10873263005368

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™ Electrode - 10873263005344

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™ Electrode - 10873263004392

microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), nonsterile
FHC, INC.
MTDWZN(BP)(BP8)-00439
Not in Commercial Distribution

  • 10873263004392 ()
  • 00873263004395 ()

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

  • Depth electrode

microTargeting™ Electrode - 10873263004095

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™ Electrode - 10873263004064

microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWXN(BP)(BP7)-00406
In Commercial Distribution

  • 10873263004064 ()
  • 00873263004067 ()

  • Outer Diameter: 0.77 Millimeter
  • Length: 10 Millimeter
  • Length: 256.4 Millimeter
  • Length: 271.4 Millimeter
MTDWXN(BP)(BP7)

  • Depth electrode

microTargeting™ Electrode - 10873263003968

microTargeting(TM) Electrode, differential, tungsten, D.ZAP(L), nonsterile
FHC, INC.
MTDWLN(BP)(BP8)-00396
In Commercial Distribution

  • 10873263003968 ()
  • 00873263003961 ()

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

  • Depth electrode

microTargeting™ Electrode - 10873263003869

microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(LS)(LS3)-00386
In Commercial Distribution

  • 10873263003869 ()
  • 00873263003862 ()

  • Length: 291.5 Millimeter
  • Length: 273.5 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
MTDWBN(LS)(LS3)

  • Depth electrode

microTargeting™ Electrode - 10873263003845

microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(BP)(BP7)-00384
In Commercial Distribution

  • 10873263003845 ()
  • 00873263003848 ()

  • Length: 256.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Length: 10 Millimeter
MTDWBN(BP)(BP7)

  • Depth electrode
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