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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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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

Quantum - 90810005669057

4.25mm dia.12mm 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-425-12F
In Commercial Distribution

  • 90810005669057 ()

  • Outer Diameter: 4.25 Millimeter
  • Length: 12 Millimeter


  • 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

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 - 00650551025412

sEEG DEPTH ELECTRODE, 4 MACRO CONTACTS, 12.5 MICRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-04-091-NS
In Commercial Distribution

  • 00650551025412 ()


  • Depth electrode

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

DEPTHALON - 00650551149989

sEEG DEPTH ELECTRODE, 68.5 MICRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-16-133-NS
In Commercial Distribution

  • 00650551149989 ()


  • Depth electrode

sEEG DEPTHALON - 00650551148739

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

sEEG DEPTHALON - 00650551148722

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

sEEG DEPTHALON - 00650551148715

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

DEPTHALON - 00650551148272

PLATINUM DEPTH ELECTRODE, 4 MACRO CONTACTS, INLINE CONNECTOR, 1 EXIT, 1 LEAD, 2 TAIL, NON-STERILE
PMT CORPORATION
2102-04-145-NS
In Commercial Distribution

  • 00650551148272 ()


  • Depth electrode

DEPTHALON - 00650551148241

PLATINUM DEPTH ELECTRODE, 10 MACRO CONTACTS, INLINE CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-10-036-NS
In Commercial Distribution

  • 00650551148241 ()


  • Depth electrode

DEPTHALON - 00650551147473

PLATINUM MICROWIRE DEPTH ELECTRODE, 10 MICRO CONTACTS, MINI CONNECTOR, NON-STERILE
PMT CORPORATION
2104-00-10-004-NS
In Commercial Distribution

  • 00650551147473 ()


  • Depth electrode

DEPTHALON - 00650551147466

PLATINUM DEPTH ELECTRODE, 10 MACRO CONTACTS, MINI CONNECTOR, MACRO/MICRO JUNCTION. NON-STERILE
PMT CORPORATION
2102-10-002-NS
In Commercial Distribution

  • 00650551147466 ()


  • Depth electrode

DEPTHALON - 00650551147459

PLATINUM DEPTH ELECTRODE, 8 MACRO CONTACTS, MINI CONNECTOR, MACRO/MICRO JUNCTION, NON-STERILE
PMT CORPORATION
2102-08-002-NS
In Commercial Distribution

  • 00650551147459 ()


  • Depth electrode

DEPTHALON - 00650551147442

PLATINUM DEPTH ELECTRODE, 6 MACRO CONTACTS, MINI CONNECTOR, MACRO/MICRO JUNCTION, NON-STERILE
PMT CORPORATION
2102-06-002-NS
In Commercial Distribution

  • 00650551147442 ()


  • Depth electrode

DEPTHALON - 00650551147435

PLATINUM DEPTH ELECTRODE, 4 MACRO CONTACTS, MINI CONNECTOR, MICRO/MACRO JUNCTIONS, NON STERILE
PMT CORPORATION
2102-04-002-NS
In Commercial Distribution

  • 00650551147435 ()


  • Depth electrode

Depthalon - 00650551144403

Depthalon Electrode, Platinum, Non-sterile, 8 Macro Contacts, 16 Microwire contacts, 38.5mm recording length, Inline connector, 1 exit, 2 leads, 2 exits
PMT CORPORATION
2104-08-16-003-NS
In Commercial Distribution

  • 00650551144403 ()


  • Depth electrode

DEPTHALON® - 00650551143888

MICROWIRE DEPTHALON ELECTRODE, 57 MICROWIRE CONTACTS, MINI CONNECTOR
PMT CORPORATION
2104-07-57-001-NS
In Commercial Distribution

  • 00650551143888 ()

  • Microwire Diameter 40 Micrometer
  • Main Tube Length 20 Centimeter
  • Contact Size 1.5 Millimeter
2104-07-57-001-NS

  • Depth electrode

DEPTHALON® - 00650551143727

MICROWIRE DEPTHALON ELECTRODE, 48 MICROWIRE CONTACTS, MINI CONNECTOR
PMT CORPORATION
2104-07-48-001-NS
In Commercial Distribution

  • 00650551143727 ()

  • Microwire Diameter 25 Micrometer
  • Main Tube Length 20 Centimeter
  • Contact Size 5 Millimeter
2104-07-48-001-NS

  • Depth electrode

DEPTHALON® - 00650551143208

sEEG, PLATINUM, 12 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-12-145-NS
In Commercial Distribution

  • 00650551143208 ()

  • Main Tube Length 27 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 57 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-12-145-NS

  • Depth electrode

DEPTHALON® - 00650551143192

sEEG, PLATINUM, 14 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-14-145-NS
In Commercial Distribution

  • 00650551143192 ()

  • Main Tube Length 27 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 67 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-14-145-NS

  • Depth electrode

DEPTHALON® - 00650551142843

sEEG, PLATINUM, 8 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-08-111-NS
In Commercial Distribution

  • 00650551142843 ()

  • Main Tube Length 27 Centimeter
  • Spacing 0.9 Millimeter
  • Recording Depth 16.7 Millimeter
  • Contact Length 1.3 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-08-111-NS

  • Depth electrode

DEPTHALON® - 00650551142805

MICROWIRE DEPTHALON ELECTRODE, 48 MICROWIRE CONTACTS, MINI CONNECTOR
PMT CORPORATION
2104-16-48-002-NS
In Commercial Distribution

  • 00650551142805 ()

  • Microwire Diameter 25 Micrometer
  • Main Tube Length 9 Centimeter
  • Contact Size 0.5 Millimeter
2104-16-48-002-NS

  • Depth electrode

DEPTHALON® - 00650551142652

MICROWIRE DEPTHALON ELECTRODE, 10 MICROWIRE CONTACTS, INLINE CONNECTOR
PMT CORPORATION
2104-00-10-002-NS
In Commercial Distribution

  • 00650551142652 ()

  • Microwire Diameter 40 Micrometer
  • Main Tube Length 22.5 Centimeter
2104-00-10-002-NS

  • Depth electrode

DEPTHALON® - 00650551142638

DEPTH ELECTRODE, PLATINUM, 4 CONTACT, NON-STANDARD CONNECTOR
PMT CORPORATION
2102-04-002-NS
In Commercial Distribution

  • 00650551142638 ()

  • Main Tube Length 22 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 17 Millimeter
  • Contact Length 2 Millimeter
2102-04-002-NS

  • Depth electrode

DEPTHALON® - 00650551142485

sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-291-NS
In Commercial Distribution

  • 00650551142485 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 33.5 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-291-NS

  • Depth electrode

DEPTHALON® - 00650551142461

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL, 27.25MM SPACING BETWEEN CONTACTS #8 & #9
PMT CORPORATION
2102-16-134-NS
In Commercial Distribution

  • 00650551142461 ()

  • Main Tube Length 55 Centimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 80 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-134-NS

  • Depth electrode

DEPTHALON® - 00650551142133

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-157-NS
In Commercial Distribution

  • 00650551142133 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 85 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-157-NS

  • Depth electrode

DEPTHALON® - 00650551141655

DEPTH ELECTRODE, PLATINUM, 4 CONTACT, MINI CONNECTOR
PMT CORPORATION
2102-04-101-NS
In Commercial Distribution

  • 00650551141655 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 12.5 Millimeter
  • Contact Length 2 Millimeter
2102-04-101-NS

  • Depth electrode

DEPTHALON® - 00650551139881

sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-155-NS
In Commercial Distribution

  • 00650551139881 ()

  • Main Tube Length 27 Centimeter
  • Spacing 6 Millimeter
  • Recording Depth 74 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-155-NS

  • Depth electrode

DEPTHALON® - 00650551139874

sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-146-NS
In Commercial Distribution

  • 00650551139874 ()

  • Main Tube Length 27 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 65 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-146-NS

  • Depth electrode

DEPTHALON® - 00650551139867

sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-149-NS
In Commercial Distribution

  • 00650551139867 ()

  • Main Tube Length 27 Centimeter
  • Spacing 4 Millimeter
  • Recording Depth 56 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-149-NS

  • Depth electrode

DEPTHALON® - 00650551139850

sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-145-NS
In Commercial Distribution

  • 00650551139850 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 47 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-145-NS

  • Depth electrode

DEPTHALON® - 00650551139843

sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-148-NS
In Commercial Distribution

  • 00650551139843 ()

  • Main Tube Length 27 Centimeter
  • Spacing 2 Millimeter
  • Recording Depth 38 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-148-NS

  • Depth electrode

DEPTHALON® - 00650551139836

sEEG, PLATINUM, 8 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-08-148-NS
In Commercial Distribution

  • 00650551139836 ()

  • Main Tube Length 27 Centimeter
  • Spacing 2 Millimeter
  • Recording Depth 30 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-08-148-NS

  • Depth electrode

DEPTHALON® - 00650551139829

sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-144-NS
In Commercial Distribution

  • 00650551139829 ()

  • Main Tube Length 27 Centimeter
  • Spacing 1 Millimeter
  • Recording Depth 29 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-144-NS

  • Depth electrode

DEPTHALON® - 00650551139812

sEEG, PLATINUM, 8 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-08-145-NS
In Commercial Distribution

  • 00650551139812 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 37 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-08-145-NS

  • Depth electrode

DEPTHALON® - 00650551139720

sEEG, PLATINUM, 6 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-06-145-NS
In Commercial Distribution

  • 00650551139720 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 27 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-06-145-NS

  • Depth electrode

DEPTHALON® - 00650551137504

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-112-NS
In Commercial Distribution

  • 00650551137504 ()

  • Main Tube Length 27 Centimeter
  • Spacing 1.37 Millimeter
  • Recording Depth 41.3 Millimeter
  • Contact Length 1.3 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-112-NS

  • Depth electrode
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