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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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EARP, TRIAL 18X35X10 6° 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-T-1835-0610
In Commercial Distribution

  • 00810135960816 ()

  • Width: 35 Millimeter
  • Depth: 18 Millimeter
  • Height: 10 Millimeter


  • General internal orthopaedic fixation system implantation kit
EARP, TRIAL 14X35X08 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.
EARP-T-1435-0008
In Commercial Distribution

  • 00810135960786 ()

  • Height: 8 Millimeter
  • Depth: 14 Millimeter
  • Width: 35 Millimeter


  • General internal orthopaedic fixation system implantation kit
EARP, TRIAL 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.
EARP-T-1425-0008
In Commercial Distribution

  • 00810135960779 ()

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


  • General internal orthopaedic fixation system implantation kit
EARP Retractor, EARP BLADE 150. The EARP Retractor is used in conjunction with TeDan Phantom ML MIS Lumbar Surgical Access System ML-2000 to assist with focal retraction, to increase working corridor and improve line of sight to working area.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-R_001-150
In Commercial Distribution

  • 00810135960748 ()


  • Self-retaining surgical retractor, reusable
EARP Retractor, EARP BLADE 140. The EARP Retractor is used in conjunction with TeDan Phantom ML MIS Lumbar Surgical Access System ML-2000 to assist with focal retraction, to increase working corridor and improve line of sight to working area.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-R_001-140
In Commercial Distribution

  • 00810135960731 ()


  • Self-retaining surgical retractor, reusable
EARP Retractor, EARP BLADE 130. The EARP Retractor is used in conjunction with TeDan Phantom ML MIS Lumbar Surgical Access System ML-2000 to assist with focal retraction, to increase working corridor and improve line of sight to working area.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-R_001-130
In Commercial Distribution

  • 00810135960724 ()


  • Self-retaining surgical retractor, reusable
EARP Retractor, EARP BLADE 120. The EARP Retractor is used in conjunction with TeDan Phantom ML MIS Lumbar Surgical Access System ML-2000 to assist with focal retraction, to increase working corridor and improve line of sight to working area.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-R_001-120
In Commercial Distribution

  • 00810135960717 ()


  • Self-retaining surgical retractor, reusable
EARP Retractor, EARP BLADE 110. The EARP Retractor is used in conjunction with TeDan Phantom ML MIS Lumbar Surgical Access System ML-2000 to assist with focal retraction, to increase working corridor and improve line of sight to working area.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-R_001-110
In Commercial Distribution

  • 00810135960700 ()


  • Self-retaining surgical retractor, reusable
EARP Retractor, EARP BLADE 90. The EARP Retractor is used in conjunction with TeDan Phantom ML MIS Lumbar Surgical Access System ML-2000 to assist with focal retraction, to increase working corridor and improve line of sight to working area.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-R_001-90
In Commercial Distribution

  • 00810135960687 ()


  • Self-retaining surgical retractor, reusable
EARP DISC SPACER 14MM 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-DS-001-14
In Commercial Distribution

  • 00810135960601 ()


  • General internal orthopaedic fixation system implantation kit
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