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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® - 00650551070351

DEPTH ELECTRODE, PLATINUM, 8 CONTACT, MINI CONNECTOR, MEG 2
PMT CORPORATION
2102-08-IL-SS-M2-NS
In Commercial Distribution

  • 00650551070351 ()

  • Contact Length 2 Millimeter
  • Main Tube Length 32 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 37 Millimeter
2102-08-IL-SS-M2-NS

  • Depth electrode

DEPTHALON® - 00650551070344

DEPTH ELECTRODE, PLATINUM, 4 CONTACT, MINI CONNECTOR, MEG 2
PMT CORPORATION
2102-04-IL-SS-M2-NS
In Commercial Distribution

  • 00650551070344 ()

  • Recording Depth 44 Millimeter
  • Spacing 10 Millimeter
  • Main Tube Length 32 Centimeter
  • Contact Length 5 Millimeter
2102-04-IL-SS-M2-NS

  • Depth electrode

DEPTHALON® - 00650551070337

DEPTH ELECTRODE, PLATINUM, 6 CONTACT, MINI CONNECTOR, MEG 2
PMT CORPORATION
2102-06-IL-SS-M2-NS
In Commercial Distribution

  • 00650551070337 ()

  • Contact Length 5 Millimeter
  • Main Tube Length 32 Centimeter
  • Spacing 10 Millimeter
  • Recording Depth 55 Millimeter
2102-06-IL-SS-M2-NS

  • Depth electrode

DEPTHALON® - 00650551070320

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-108-NS
In Commercial Distribution

  • 00650551070320 ()

  • Recording Depth 90 Millimeter
  • Spacing 3.5 Millimeter
  • Outer Diameter: 0.8 Millimeter
  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
2102-16-108-NS

  • Depth electrode

DEPTHALON® - 00650551070313

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-098-NS
In Commercial Distribution

  • 00650551070313 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 90 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-16-098-NS

  • Depth electrode

DEPTHALON® - 00650551070306

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-107-NS
In Commercial Distribution

  • 00650551070306 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 80 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-16-107-NS

  • Depth electrode

DEPTHALON® - 00650551070290

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-097-NS
In Commercial Distribution

  • 00650551070290 ()

  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 80 Millimeter
  • Spacing 3.5 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-097-NS

  • Depth electrode

DEPTHALON® - 00650551070283

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-106-NS
In Commercial Distribution

  • 00650551070283 ()

  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 68.5 Millimeter
  • Spacing 4.43 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-106-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
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