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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® - 00650551070061

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-093-NS
In Commercial Distribution

  • 00650551070061 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 4.43 Millimeter
  • Recording Depth 68.5 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-16-093-NS

  • Depth electrode

DEPTHALON® - 00650551070054

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-092-NS
In Commercial Distribution

  • 00650551070054 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 3.97 Millimeter
  • Recording Depth 61.5 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-16-092-NS

  • Depth electrode

DEPTHALON® - 00650551070047

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-091-NS
In Commercial Distribution

  • 00650551070047 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 54.5 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-16-091-NS

  • Depth electrode

DEPTHALON® - 00650551070030

sEEG, PLATINUM, 14 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-14-101-NS
In Commercial Distribution

  • 00650551070030 ()

  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 47.5 Millimeter
  • Spacing 3.5 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-14-101-NS

  • Depth electrode

DEPTHALON® - 00650551070023

sEEG, PLATINUM, 14 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-14-091-NS
In Commercial Distribution

  • 00650551070023 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 47.5 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-14-091-NS

  • Depth electrode

DEPTHALON® - 00650551070016

sEEG, PLATINUM, 12 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-12-101-NS
In Commercial Distribution

  • 00650551070016 ()

  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 40.5 Millimeter
  • Spacing 3.5 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-12-101-NS

  • Depth electrode

DEPTHALON® - 00650551070009

sEEG, PLATINUM, 12 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-12-091-NS
In Commercial Distribution

  • 00650551070009 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 40.5 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-12-091-NS

  • Depth electrode

DEPTHALON® - 00650551069997

sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-10-101-NS
In Commercial Distribution

  • 00650551069997 ()

  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 33.5 Millimeter
  • Spacing 3.5 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-101-NS

  • Depth electrode

DEPTHALON® - 00650551069980

sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-091-NS
In Commercial Distribution

  • 00650551069980 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 33.5 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-10-091-NS

  • Depth electrode

DEPTHALON® - 00650551069973

sEEG, PLATINUM, 8 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-08-101-NS
In Commercial Distribution

  • 00650551069973 ()

  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 26.5 Millimeter
  • Spacing 3.5 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-08-101-NS

  • Depth electrode

DEPTHALON® - 00650551069966

sEEG, PLATINUM, 8 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-08-091-NS
In Commercial Distribution

  • 00650551069966 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 26.5 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-08-091-NS

  • Depth electrode

DEPTHALON® - 00650551069959

DEPTH ELECTRODE, STAINLESS STEEL, 10 CONTACT, MINI CONNECTOR
PMT CORPORATION
2101-10-MN-SS-NS
In Commercial Distribution

  • 00650551069959 ()

  • Contact Length 2 Millimeter
  • Recording Depth 47 Millimeter
  • Spacing 5 Millimeter
  • Main Tube Length 32 Centimeter
2101-10-MN-SS-NS

  • Depth electrode

DEPTHALON® - 00650551069942

DEPTH ELECTRODE, STAINLESS STEEL, 10 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2101-10-IL-SS-NS
In Commercial Distribution

  • 00650551069942 ()

  • Main Tube Length 32 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 47 Millimeter
  • Contact Length 2 Millimeter
2101-10-IL-SS-NS

  • Depth electrode

DEPTHALON® - 00650551069935

DEPTH ELECTRODE, STAINLESS STEEL, 10 CONTACT, MINI CONNECTOR
PMT CORPORATION
2101-10-087-NS
In Commercial Distribution

  • 00650551069935 ()

  • Main Tube Length 32 Centimeter
  • Spacing 10 Millimeter
  • Recording Depth 92 Millimeter
  • Contact Length 2 Millimeter
2101-10-087-NS

  • Depth electrode

DEPTHALON® - 00650551069928

DEPTH ELECTRODE, STAINLESS STEEL, 10 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2101-10-086-NS
In Commercial Distribution

  • 00650551069928 ()

  • Contact Length 2 Millimeter
  • Recording Depth 47 Millimeter
  • Spacing 5 Millimeter
  • Main Tube Length 32 Centimeter
2101-10-086-NS

  • Depth electrode

DEPTHALON® - 00650551069911

DEPTH ELECTRODE, STAINLESS STEEL, 10 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2101-10-085-NS
In Commercial Distribution

  • 00650551069911 ()

  • Contact Length 2 Millimeter
  • Recording Depth 92 Millimeter
  • Spacing 10 Millimeter
  • Main Tube Length 32 Centimeter
2101-10-085-NS

  • Depth electrode

DEPTHALON® - 00650551069904

DEPTH ELECTRODE, STAINLESS STEEL, 10 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2101-10-084-NS
In Commercial Distribution

  • 00650551069904 ()

  • Spacing 10 Millimeter
  • Recording Depth 95 Millimeter
  • Contact Length 5 Millimeter
  • Main Tube Length 32 Centimeter
2101-10-084-NS

  • Depth electrode

DEPTHALON® - 00650551069898

DEPTH ELECTRODE, STAINLESS STEEL, 10 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2101-10-081-NS
In Commercial Distribution

  • 00650551069898 ()

  • Main Tube Length 30 Centimeter
  • Spacing 7.5 Millimeter
  • Recording Depth 69.5 Millimeter
  • Contact Length 2 Millimeter
2101-10-081-NS

  • Depth electrode

DEPTHALON® - 00650551069881

DEPTH ELECTRODE, STAINLESS STEEL, 10 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2101-10-059-NS
In Commercial Distribution

  • 00650551069881 ()

  • Main Tube Length 32 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 47 Millimeter
  • Contact Length 2 Millimeter
2101-10-059-NS

  • Depth electrode

DEPTHALON® - 00650551069874

DEPTH ELECTRODE, STAINLESS STEEL, 10 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2101-10-038-NS
In Commercial Distribution

  • 00650551069874 ()

  • Main Tube Length 32 Centimeter
  • Spacing 4.5 Millimeter
  • Recording Depth 42.5 Millimeter
  • Contact Length 2 Millimeter
2101-10-038-NS

  • Depth electrode

DJO Origin Instrument Tray - 09348215058098

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-409
In Commercial Distribution

  • 09348215058098 ()


  • Instrument tray, reusable

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

Drive Headstage - 07290114061520

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Drive Headstage
In Commercial Distribution

  • 07290114061520 ()
700-006000-00

  • Depth electrode

EARP Interbody System - 00810135960007

EARP, 14X25X08 0° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP1425-0008
In Commercial Distribution

  • 00810135960007 ()

  • Depth: 14 Millimeter
  • Width: 25 Millimeter
  • Height: 8 Millimeter


  • Polymeric spinal interbody fusion cage

ENDOSKELETON® TAS - 00191375028338

Graft Packing & Screw Reference Block
TITAN SPINE, LLC
2300-1317
Not in Commercial Distribution

  • 00191375028338 ()

  • Width: 1.5 Inch
  • Length: 2 Inch
  • Height: 1.25 Inch
2300-1317

  • Bone graft packing block

ENDOSKELETON® TCS - 00191375028345

Graft Packing & Screw Reference Block
TITAN SPINE, LLC
5210-1017
Not in Commercial Distribution

  • 00191375028345 ()

  • Height: 1 Inch
  • Width: 2 Inch
  • Length: 1.5 Inch
5210-1017

  • Bone graft packing block

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

FOCUS - 00810005667241

Rod, Lordotic 5.5X95mm. 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 fusion5
NVISION BIOMEDICAL TECHNOLOGIES, INC.
L-01-095
In Commercial Distribution

  • 00810005667241 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 95 Millimeter


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

FOCUS - 00814008029730

Rod, MIS, Lordotic 5.5X130mm. 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.
M-01-130
In Commercial Distribution

  • 00814008029730 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 130 Millimeter


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

FOCUS - 00814008029723

Rod, MIS, Lordotic 5.5X120mm. 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.
M-01-120
In Commercial Distribution

  • 00814008029723 ()

  • Length: 120 Millimeter
  • Outer Diameter: 5.5 Millimeter


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