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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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tangis - 90814008023809

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

tangis - 90814008023748

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

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

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 - M7161124411150

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

  • M7161124411150 ()


  • Orthopaedic broach

OrthoMedFlex - M7161124411140

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

  • M7161124411140 ()


  • Orthopaedic broach

OrthoMedFlex - M7161124411130

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

  • M7161124411130 ()


  • Orthopaedic broach

OrthoMedFlex - M7161124411120

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

  • M7161124411120 ()


  • Orthopaedic broach

OrthoMedFlex - M7161124411110

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

  • M7161124411110 ()


  • Orthopaedic broach

OrthoMedFlex - M7161124411100

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

  • M7161124411100 ()


  • 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

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

DEPTHALON® - 00650551131496

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL, 36MM SPACING BETWEEN CONTACTS #13 & #14
PMT CORPORATION
2102-16-154-NS
In Commercial Distribution

  • 00650551131496 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 110 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-154-NS

  • Depth electrode

DEPTHALON® - 00650551131489

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL, 21MM SPACING BETWEEN CONTACTS #13 AND #14
PMT CORPORATION
2102-16-153-NS
In Commercial Distribution

  • 00650551131489 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 95 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-153-NS

  • Depth electrode

DEPTHALON® - 00650551131472

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL, 13.98MM SPACING BETWEEN CONTACTS #13 AND #14
PMT CORPORATION
2102-16-152-NS
In Commercial Distribution

  • 00650551131472 ()

  • Main Tube Length 27 Centimeter
  • Spacing 2.43 Millimeter
  • Recording Depth 80 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-152-NS

  • Depth electrode

DEPTHALON® - 00650551131465

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL, 12MM SPACING BETWEEN CONTACTS #13 AND #14
PMT CORPORATION
2102-16-151-NS
In Commercial Distribution

  • 00650551131465 ()

  • Main Tube Length 27 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 65 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-151-NS

  • Depth electrode

DEPTHALON® - 00650551131458

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-143-NS
In Commercial Distribution

  • 00650551131458 ()

  • Main Tube Length 27 Centimeter
  • Spacing 2.8 Millimeter
  • Recording Depth 75 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-143-NS

  • Depth electrode

DEPTHALON® - 00650551131441

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-142-NS
In Commercial Distribution

  • 00650551131441 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 85 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-142-NS

  • Depth electrode

DEPTHALON® - 00650551131434

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-141-NS
In Commercial Distribution

  • 00650551131434 ()

  • Main Tube Length 27 Centimeter
  • Spacing 4.5 Millimeter
  • Recording Depth 100 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-141-NS

  • Depth electrode

DEPTHALON® - 00650551131427

sEEG, PLATINUM, 14 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-14-131-NS
In Commercial Distribution

  • 00650551131427 ()

  • Main Tube Length 60 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 47.5 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-14-131-NS

  • Depth electrode

DEPTHALON® - 00650551131410

sEEG, PLATINUM, 12 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-12-131-NS
In Commercial Distribution

  • 00650551131410 ()

  • Main Tube Length 60 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 40.5 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-12-131-NS

  • Depth electrode

DEPTHALON® - 00650551131403

sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-131-NS
In Commercial Distribution

  • 00650551131403 ()

  • Main Tube Length 60 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 33.5 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-131-NS

  • Depth electrode

DEPTHALON® - 00650551131397

sEEG, PLATINUM, 8 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-08-131-NS
In Commercial Distribution

  • 00650551131397 ()

  • Main Tube Length 60 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 26.5 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-08-131-NS

  • Depth electrode
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