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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® - 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® - 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® - 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® - 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® - 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® - 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

DEVEX - 10705034212470

DEVEX SYSTEM CAGE FILLER BLOCK
DEPUY SPINE, LLC
286409000
Not in Commercial Distribution

  • 10705034212470 ()
286409000

  • Bone graft packing block

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 INSTRUMENTS - 00810135961103

EARP RETRACTOR TRAY. 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.
EARP-TRAY02-XXX
In Commercial Distribution

  • 00810135961103 ()


  • Surgical instrument/implant rack

EARP INSTRUMENTS - 00810135961097

EARP INSTRUMENT AND IMPLANT TRAY. 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.
EARP-TRAY01-XXX
In Commercial Distribution

  • 00810135961097 ()


  • Surgical instrument/implant rack

EARP INSTRUMENTS - 00810135961059

EARP DISC RAKE ANGLED. 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.
EARP-DRA
In Commercial Distribution

  • 00810135961059 ()

  • Width: 35 Millimeter
  • Depth: 22 Millimeter
  • Height: 14 Millimeter


  • General internal orthopaedic fixation system implantation kit

EARP INSTRUMENTS - 00810135961042

EARP DISC RAKE 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.
EARP-DR
In Commercial Distribution

  • 00810135961042 ()

  • Width: 35 Millimeter
  • Depth: 22 Millimeter
  • Height: 14 Millimeter


  • General internal orthopaedic fixation system implantation kit

EARP INSTRUMENTS - 00810135961035

EARP, IMPLANT CADDIE 22X45. 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.
EARP-IC_2245
In Commercial Distribution

  • 00810135961035 ()


  • Surgical instrument/implant rack

EARP INSTRUMENTS - 00810135961028

EARP, IMPLANT CADDIE 22X40. 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.
EARP-IC_2240
In Commercial Distribution

  • 00810135961028 ()


  • Surgical instrument/implant rack

EARP INSTRUMENTS - 00810135961011

EARP, IMPLANT CADDIE 22X35. 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.
EARP-IC_2235
In Commercial Distribution

  • 00810135961011 ()


  • Surgical instrument/implant rack

EARP INSTRUMENTS - 00810135961004

EARP, IMPLANT CADDIE 18X45. 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.
EARP-IC_1845
In Commercial Distribution

  • 00810135961004 ()


  • Surgical instrument/implant rack

EARP INSTRUMENTS - 00810135960991

EARP, IMPLANT CADDIE 18X40. 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.
EARP-IC_1840
In Commercial Distribution

  • 00810135960991 ()


  • Surgical instrument/implant rack

EARP INSTRUMENTS - 00810135960984

EARP, IMPLANT CADDIE 18X35. 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.
EARP-IC_1835
In Commercial Distribution

  • 00810135960984 ()


  • Surgical instrument/implant rack
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