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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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EVOL®ha-C Cervical Interbody System - 00841193121246

EVOL®ha-C Cervical Bone Packing Block
Cutting Edge Spine, LLC
CES-472
In Commercial Distribution

  • 00841193121246 ()

  • Length: 50 Millimeter
CES-472

  • Bone graft packing block

microTargeting™ Array Electrode - 10873263007911

microTargeting™ Array Frame Platinum 6X Non Sterile
FHC, INC.
25335Z-00791
In Commercial Distribution

  • 10873263007911 ()
  • 00873263007914 ()

  • Outer Diameter: 0.56 Millimeter
  • Length: 276.5 Millimeter
  • Length: 3 Millimeter
  • Length: 268.5 Millimeter
  • Impedance: Megaohms
25335Z

  • Depth electrode

microTargeting™ Array Electrode - 10873263007898

microTargeting™ Array Electrodes 6x Non Sterile
FHC, INC.
22335Z-00789
In Commercial Distribution

  • 10873263007898 ()
  • 00873263007891 ()

  • Length: 3 Millimeter
  • Length: 276.5 Millimeter
  • Length: 268.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
22335Z

  • Depth electrode

microTargeting™ Electrode - 10873263007485

microTargeting Electrode 5x, non-sterile, Array, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC1003-00748
In Commercial Distribution

  • 10873263007485 ()
  • 00873263007488 ()

  • Length: 10 Millimeter
  • Length: 276.5 Millimeter
  • Length: 261.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
FC1003

  • Depth electrode

microTargeting™ Electrode - 10873263006709

microTargeting Electrode, differential, 5mm ext, tungsten, non-sterile
FHC, INC.
MTDWBN(SP)(BW1)-00670
In Commercial Distribution

  • 10873263006709 ()
  • 00873263006702 ()

  • Length: 5 Millimeter
  • Length: 266.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
MTDWBN(SP)(BW1)

  • Depth electrode

microTargeting™ Electrode - 10873263006501

microTargeting™ Electrode, differential, platinum/iridium, nonsterile
FHC, INC.
MTDPZN(AO)(AO1)-00650
In Commercial Distribution

  • 10873263006501 ()
  • 00873263006504 ()

  • Outer Diameter: 1.27 Millimeter
  • Impedance: Megaohms
  • Length: 274 Millimeter
  • Length: 282 Millimeter
  • Length: 3 Millimeter
MTDPZN(AO)(AO1)

  • Depth electrode

microTargeting™ Electrode - 10873263005573

microTargeting(TM) Electrode, differential, tungsten ground tip, nonsterile
FHC, INC.
MTDWXN(BS)(OC4)-00557
In Commercial Distribution

  • 10873263005573 ()
  • 00873263005576 ()

  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 1 Millimeter
  • Length: 270.5 Millimeter
MTDWXN(BS)(OC4)

  • Depth electrode

microTargeting™ Electrode - 10873263004880

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™ Electrode - 10873263004866

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™ Electrode - 10873263004828

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™ Electrode - 10873263004750

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™ Electrode - 10873263004316

microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), nonsterile
FHC, INC.
MTDWZN(AR)(AR1)-00431
Not in Commercial Distribution

  • 10873263004316 ()
  • 00873263004319 ()

  • Outer Diameter: 0.55 Millimeter
  • Length: 3 Millimeter
  • Impedance: Megaohms
  • Length: 268.5 Millimeter
  • Length: 276.5 Millimeter
MTDWZN(AR)(AR1)

  • Depth electrode

microTargeting™ Electrode - 10873263004262

microTargeting(TM) Electrode, 6x, differential, tungsten, DZAP(Z)
FHC, INC.
MTDWZN(AO)(AO9)-00426
In Commercial Distribution

  • 10873263004262 ()
  • 00873263004265 ()

  • Length: 3 Millimeter
  • Outer Diameter: 1.27 Millimeter
  • Impedance: Megaohms
  • Length: 241.86 Millimeter
  • Length: 233.86 Millimeter
MTDWZN(AO)(AO9)

  • Depth electrode

microTargeting™ Electrode - 10873263004118

microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWXN(SP)(JV1)-00411
In Commercial Distribution

  • 10873263004118 ()
  • 00873263004111 ()

  • Length: 276.5 Millimeter
  • Length: 1 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 270.5 Millimeter
MTDWXN(SP)(JV1)

  • Depth electrode

microTargeting™ Electrode - 10873263004040

microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWXN(AR)(AR2)-00404
In Commercial Distribution

  • 10873263004040 ()
  • 00873263004043 ()

  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
  • Length: 261.5 Millimeter
  • Length: 10 Millimeter
MTDWXN(AR)(AR2)

  • Depth electrode

microTargeting™ Electrode - 10873263003944

microTargeting(TM) Electrode, differential, tungsten, D.ZAP(L)
FHC, INC.
MTDWLN(AR)(AR1)-00394
Not in Commercial Distribution

  • 10873263003944 ()
  • 00873263003947 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 3 Millimeter
  • Length: 268.5 Millimeter
  • Length: 276.5 Millimeter
MTDWLN(AR)(AR1)

  • Depth electrode

microTargeting™ Electrode - 10873263003920

microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWCN(AR)(AR2)-00392
In Commercial Distribution

  • 10873263003920 ()
  • 00873263003923 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
  • Length: 261.5 Millimeter
MTDWCN(AR)(AR2)

  • Depth electrode

microTargeting™ Electrode - 10873263003753

microTargeting Electrode, differential, tungsten, non-sterile
FHC, INC.
MTDWBN(AR)(AR2)-00375
In Commercial Distribution

  • 10873263003753 ()
  • 00873263003756 ()

  • Length: 261.5 Millimeter
  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
MTDWBN(AR)(AR2)

  • Depth electrode

microTargeting™ Electrode - 10873263003722

microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(AO)(AO1)-00372
In Commercial Distribution

  • 10873263003722 ()
  • 00873263003725 ()

  • Length: 282 Millimeter
  • Outer Diameter: 1.27 Millimeter
  • Impedance: Megaohms
  • Length: 3 Millimeter
  • Length: 274 Millimeter
MTDWBN(AO)(AO1)

  • Depth electrode

microTargeting™ Electrode - 10873263003630

microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(AO)(A10)-00363
In Commercial Distribution

  • 10873263003630 ()
  • 00873263003633 ()

  • Length: 242 Millimeter
  • Length: 210 Millimeter
  • Outer Diameter: 1.27 Millimeter
  • Length: 27 Millimeter
  • Impedance: Megaohms
MTDWBN(AO)(A10)

  • Depth electrode

microTargeting™ Electrode - 10873263003609

microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWAN(AR)(AR1)-00360
Not in Commercial Distribution

  • 10873263003609 ()
  • 00873263003602 ()

  • Impedance: Megaohms
  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 3 Millimeter
  • Length: 268.5 Millimeter
MTDWAN(AR)(AR1)

  • Depth electrode

microTargeting™ Electrode - 10873263003357

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™ Electrode - 10873263002978

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 - 10873263002411

microTargeting(TM) Electrode, non sterile, 6x, Array, D.ZAP(Z), T=30 for use with frame, STar or MT Drive
FHC, INC.
22635Z-00241
In Commercial Distribution

  • 10873263002411 ()
  • 00873263002414 ()

  • Impedance: Megaohms
  • Length: 261.5 Millimeter
  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
22635Z

  • Depth electrode

microTargeting™ Electrode - 10873263002404

microTargeting(TM) Electrode, non-sterile, 6x, array, D.ZAP(L), T=30 for use with frame, STar or MT Drive
FHC, INC.
22635L-00240
In Commercial Distribution

  • 10873263002404 ()
  • 00873263002407 ()

  • Impedance: Megaohms
  • Length: 261.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
22635L

  • Depth electrode

microTargeting™ Electrode - 10873263002398

microTargeting(TM) Electrode, 6x, non-sterile, Array, 1 Meg, T=30 for use with frame and STar or mT drive
FHC, INC.
22630R-00239
In Commercial Distribution

  • 10873263002398 ()
  • 00873263002391 ()

  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 261.5 Millimeter
  • Impedance: Megaohms
22630R

  • Depth electrode

microTargeting™ Electrode - 10873263001360

microTargeting Electrode 6x, non-sterile, Array, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC1003-00136
Not in Commercial Distribution

  • 10873263001360 ()
  • 00873263001363 ()

  • Length: 276.5 Millimeter
  • Length: 261.5 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
FC1003

  • Depth electrode

FOCUS - 00814008029464

PS, MIS-Tower Reduction, 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.
PDR-850-050
In Commercial Distribution

  • 00814008029464 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 50 Millimeter


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

FOCUS - 00814008028962

PS, MIS-Tower Reduction, 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.
PDCR-850-050
In Commercial Distribution

  • 00814008028962 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 50 Millimeter


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

FOCUS - 00814008028726

PS, MIS-Tower Reduction, 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.
PDCR-550-050
In Commercial Distribution

  • 00814008028726 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 50 Millimeter


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