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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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DEPTHALON - 00650551002659

SEEG, PLATINUM, 2MM X 4 CONTACTS, 0.5MM X 12 CONTACTS, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL, 0.8MM OD, 25MM RECORDING DEPTH, NON-STANDARD SPACING, 27CM MAIN TUBE LENGTH, NON-STERILE
PMT CORPORATION
2102-16-185-NS
In Commercial Distribution

  • 00650551002659 ()


  • Depth electrode

DEPTHALON - 00650551002642

SEEG, PLATINUM, 2MM X 4 CONTACTS, 0.5MM X 12 CONTACTS, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL, 0.8MM OD, 25MM RECORDING DEPTH, NON-STANDARD SPACING, 27CM MAIN TUBE LENGTH, NON-STERILE
PMT CORPORATION
2102-16-184-NS
In Commercial Distribution

  • 00650551002642 ()


  • Depth electrode

DEPTHALON - 00650551001140

SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 41MM RECORDING DEPTH, REMOVABLE STYLET, 2.4MM DRILL. NON-STERILE
PMT CORPORATION
2102-16-177-NS
In Commercial Distribution

  • 00650551001140 ()


  • Depth electrode

DEPTHALON - 00650551000860

SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 48MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL, NON-STERILE
PMT CORPORATION
2102-16-176-NS
In Commercial Distribution

  • 00650551000860 ()


  • Depth electrode

DEPTHALON - 00650551000853

SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 44.5MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL, NON-STERILE
PMT CORPORATION
2102-16-175-NS
In Commercial Distribution

  • 00650551000853 ()


  • Depth electrode

DEPTHALON - 00650551000471

MICROWIRE DEPTHALON ELECTRODE, 1.5MM CONTACTS MARCO CONTACT DIA., 8 MACRO CONTACTS, 16 MICROWIRE CONTACTS, 51.1MM RECORDING LENGTH, MINI CONNECTOR, NON-STERILE
PMT CORPORATION
2104-08-16-006-NS
In Commercial Distribution

  • 00650551000471 ()


  • Depth electrode

Orthopaedic & Spine Development (OSD) - 03760178394857

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0002-02
In Commercial Distribution

  • 03760178394857 ()


  • General internal orthopaedic fixation system implantation kit

Orthopaedic & Spine Development (OSD) - 03760178394840

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0002
In Commercial Distribution

  • 03760178394840 ()


  • General internal orthopaedic fixation system implantation kit

Orthopaedic & Spine Development (OSD) - 03760178394833

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0001
In Commercial Distribution

  • 03760178394833 ()


  • General internal orthopaedic fixation system implantation kit

Orthopaedic & Spine Development (OSD) - 03760178394826

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-SQA-0025
In Commercial Distribution

  • 03760178394826 ()


  • General internal orthopaedic fixation system implantation kit

Orthopaedic & Spine Development (OSD) - 03760178394802

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-CPL-0002
In Commercial Distribution

  • 03760178394802 ()


  • General internal orthopaedic fixation system implantation kit

OrthoMedFlex - M7161124411150

Origin R Broach Size 15
ORTHOMEDFLEX LLC
112-44-1115
In Commercial Distribution

  • M7161124411150 ()


  • Orthopaedic broach

OrthoMedFlex - M7161124411130

Origin R Broach Size 13
ORTHOMEDFLEX LLC
112-44-1113
In Commercial Distribution

  • M7161124411130 ()


  • Orthopaedic broach

OrthoMedFlex - M7161124411110

Origin R Broach Size 11
ORTHOMEDFLEX LLC
112-44-1111
In Commercial Distribution

  • M7161124411110 ()


  • Orthopaedic broach

OrthoMedFlex - M7161124411090

Origin R Broach Size 9
ORTHOMEDFLEX LLC
112-44-1109
In Commercial Distribution

  • M7161124411090 ()


  • Orthopaedic broach

OrthoMedFlex - M7161124411080

Origin R Broach Size 8
ORTHOMEDFLEX LLC
112-44-1108
In Commercial Distribution

  • M7161124411080 ()


  • Orthopaedic implant impactor, reusable

OrthoMedFlex - M7161124411180

Origin R Broach Size 18
ORTHOMEDFLEX LLC
112-44-1118
In Commercial Distribution

  • M7161124411180 ()


  • Orthopaedic broach

OrthoMedFlex - M7161124411160

Origin R Broach Size 16
ORTHOMEDFLEX LLC
112-44-1116
In Commercial Distribution

  • M7161124411160 ()


  • Orthopaedic broach

OrthoMedFlex - M7161124411140

Origin R Broach Size 14
ORTHOMEDFLEX LLC
112-44-1114
In Commercial Distribution

  • M7161124411140 ()


  • Orthopaedic broach

OrthoMedFlex - M7161124411120

Origin R Broach Size 12
ORTHOMEDFLEX LLC
112-44-1112
In Commercial Distribution

  • M7161124411120 ()


  • Orthopaedic broach

OrthoMedFlex - M7161124411100

Origin R Broach Size 10
ORTHOMEDFLEX LLC
112-44-1110
In Commercial Distribution

  • M7161124411100 ()


  • Orthopaedic broach

Omnia Medical PsiF - 00843511100636

PsiF Post Packer (Long Impactor) Instrument
OMNIA MEDICAL, LLC
01-01-0010
In Commercial Distribution

  • 00843511100636 ()
01-01-0010

  • Bone graft packing block

Omnia Medical VBR - 00843511100421

Omnia Medical VBR, Graft Packing Block
OMNIA MEDICAL, LLC
06-5V-PAC1
In Commercial Distribution

  • 00843511100421 ()
06-5V-PAC1

  • Bone graft packing block

tangis - 90814008023847

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

tangis - 90814008023489

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

tangis - 90814008023403

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

tangis - 90814008023359

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

tangis - 90814008023281

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

Quantum - 90810005669170

4.25mm dia.12mm long variable screw Implant. The Quantum 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.
PCP-425-12V
In Commercial Distribution

  • 90810005669170 ()

  • Outer Diameter: 4.25 Millimeter
  • Length: 12 Millimeter


  • Intervertebral-body internal spinal fixation system

Quantum - 90810005669064

4.25mm dia.14mm long fixed screw Implant. The Quantum 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.
PCP-425-14F
In Commercial Distribution

  • 90810005669064 ()

  • Outer Diameter: 4.25 Millimeter
  • Length: 14 Millimeter


  • Intervertebral-body internal spinal fixation system
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