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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Anterior Cervical Plating System, 4.25mm dia. 20mm long variable screw. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-425-20V
In Commercial Distribution

  • 90814008023847 ()

  • Height: 20 Millimeter
  • Width: 4.25 Millimeter
  • Depth: 4.25 Millimeter


  • Intervertebral-body internal spinal fixation system
Anterior Cervical Plating System, 4.75mm dia. 14mm long variable screw. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-475-14V
In Commercial Distribution

  • 90814008023809 ()

  • Height: 14 Millimeter
  • Width: 4.75 Millimeter
  • Depth: 4.75 Millimeter
ACP-475-14V

  • Intervertebral-body internal spinal fixation system
Anterior Cervical Plating System, 4.25mm dia. 12mm long variable screw. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-425-12V
In Commercial Distribution

  • 90814008023748 ()

  • Height: 12 Millimeter
  • Width: 4.25 Millimeter
  • Depth: 4.25 Millimeter
ACP-425-12V

  • Intervertebral-body internal spinal fixation system
Anterior Cervical Plating System, 4.25mm dia. 12mm long fixed screw. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-425-12F
In Commercial Distribution

  • 90814008023625 ()

  • Height: 12 Millimeter
  • Width: 4.25 Millimeter
  • Depth: 4.25 Millimeter
ACP-425-12F

  • Intervertebral-body internal spinal fixation system
Anterior Cervical Plating System, 3.75mm dia. 12mm long fixed screw. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-375-12F
In Commercial Distribution

  • 90814008023564 ()

  • Height: 12 Millimeter
  • Width: 3.75 Millimeter
  • Depth: 3.75 Millimeter
ACP-375-12F

  • Intervertebral-body internal spinal fixation system
Anterior Cervical Plating System, 4 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-4-80
In Commercial Distribution

  • 90814008023519 ()

  • Height: 80 Millimeter
  • Width: 17 Millimeter
  • Depth: 1.98 Millimeter
ACP-4-80

  • Intervertebral-body internal spinal fixation system
Anterior Cervical Plating System, 4 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-4-68
In Commercial Distribution

  • 90814008023489 ()

  • Height: 68 Millimeter
  • Width: 17 Millimeter
  • Depth: 1.98 Millimeter
ACP-4-68

  • Intervertebral-body internal spinal fixation system
Anterior Cervical Plating System, 3 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-3-74
In Commercial Distribution

  • 90814008023441 ()

  • Height: 74 Millimeter
  • Width: 17 Millimeter
  • Depth: 1.98 Millimeter
ACP-3-74

  • Intervertebral-body internal spinal fixation system
Anterior Cervical Plating System, 3 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-3-62
In Commercial Distribution

  • 90814008023403 ()

  • Height: 62 Millimeter
  • Width: 17 Millimeter
  • Depth: 1.98 Millimeter
ACP-3-62

  • Intervertebral-body internal spinal fixation system
Anterior Cervical Plating System, 2 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-2-51
In Commercial Distribution

  • 90814008023359 ()

  • Height: 51 Millimeter
  • Width: 17 Millimeter
  • Depth: 1.98 Millimeter


  • Intervertebral-body internal spinal fixation system
Anterior Cervical Plating System, 2 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-2-33
In Commercial Distribution

  • 90814008023298 ()

  • Height: 33 Millimeter
  • Width: 17 Millimeter
  • Depth: 1.98 Millimeter
ACP-2-33

  • Intervertebral-body internal spinal fixation system
Anterior Cervical Plating System, 1 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-1-34
In Commercial Distribution

  • 90814008023281 ()

  • Height: 34 Millimeter
  • Width: 17 Millimeter
  • Depth: 1.98 Millimeter
ACP-1-34

  • Intervertebral-body internal spinal fixation system
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-16-171-NS
In Commercial Distribution

  • 00650551148739 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-16-170-NS
In Commercial Distribution

  • 00650551148722 ()


  • Depth electrode
PLATINUM sEEG ELECTRODE, 16 MACRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-16-169-NS
In Commercial Distribution

  • 00650551148715 ()


  • Depth electrode
one.click is a mechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rNDA origin]) in cartridges.
EMD SERONO, INC.
U1222402
In Commercial Distribution

  • 04054839025792 ()


  • Cartridge-accepting autoinjector, mechanical
PACKING STATION EX0818003 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0818003
In Commercial Distribution

  • 00763000216948 ()


  • Bone graft packing block
STATION EX0220045 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0220045
In Commercial Distribution

  • 00763000371777 ()


  • Bone graft packing block
microTargeting™ Platform Platinum 6X Non Sterile
FHC, INC.
45335Z-00799
In Commercial Distribution

  • 10873263007997 ()
  • 00873263007990 ()

  • Length: 212.72 Millimeter
  • Impedance: Megaohms
  • Length: 3 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 220.72 Millimeter
45335Z

  • Depth electrode
microTargeting™ Platform 6X Non Sterile
FHC, INC.
44335Z-00797
In Commercial Distribution

  • 10873263007973 ()
  • 00873263007976 ()

  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
  • Length: 212.72 Millimeter
  • Length: 220.72 Millimeter
  • Length: 3 Millimeter
44335Z

  • Depth electrode
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 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 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, differential, tungsten, nonsterile
FHC, INC.
MTDWXN(AR)(MP1)-00744
In Commercial Distribution

  • 10873263007447 ()
  • 00873263007440 ()

  • Lumen/Inner Diameter: 0.55 Millimeter
  • Length: 220.72 Millimeter
  • Length: 205.72 Millimeter
  • Length: 10 Millimeter
MTDWXN(AR)(MP1)

  • Depth electrode
microTargeting™ Electrode, differential, tungsten, D.ZAP(L), nonsterile
FHC, INC.
MTDWLN(BP)(BP7)-00743
In Commercial Distribution

  • 10873263007430 ()
  • 00873263007433 ()

  • Length: 271.4 Millimeter
  • Length: 256.4 Millimeter
  • Length: 10 Millimeter
  • Lumen/Inner Diameter: 0.77 Millimeter
  • Impedance: Megaohms
MTDWLN(BP)(BP7)

  • Depth electrode
microTargeting Electrode, differential, tungsten, non-sterile
FHC, INC.
MTDWBN(AR)(DB1)-00742
In Commercial Distribution

  • 10873263007423 ()
  • 00873263007426 ()

  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
  • Length: 234.22 Millimeter
  • Length: 249.22 Millimeter
  • Length: 10 Millimeter
MTDWBN(AR)(DB1)

  • Depth electrode
microTargeting(TM) Electrode, Back loaded, Platinum/Iridium with Glass Insulation
FHC, INC.
MTBPBN(DT1)-00671
In Commercial Distribution

  • 10873263006716 ()
  • 00873263006719 ()

  • Length: 300 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.63 Millimeter
MTBPBN(DT1)

  • Depth electrode
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™ Electrodes, differential, tungsten, non-sterile, DZAP
FHC, INC.
MTDWZN(SS)(BP8)-00660
In Commercial Distribution

  • 10873263006600 ()
  • 00873263006603 ()

  • Outer Diameter: 0.7 Millimeter
  • Length: 3 Millimeter
  • Impedance: Megaohms
  • Length: 263.4 Millimeter
  • Length: 268.4 Millimeter
MTDWZN(SS)(BP8)

  • Depth electrode
microTargeting™ Electrodes, differential, tungsten, non-sterile, LZAP
FHC, INC.
MTDWLN(SS)(BP8)-00658
In Commercial Distribution

  • 10873263006587 ()
  • 00873263006580 ()

  • Length: 3 Millimeter
  • Impedance: Megaohms
  • Length: 268.4 Millimeter
  • Length: 263.4 Millimeter
  • Outer Diameter: 0.7 Millimeter
MTDWLN(SS)(BP8)

  • Depth electrode
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