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, 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
E-Z LINK
MEGADYNE MEDICAL PRODUCTS, INC.
MGEZLINK01
In Commercial Distribution

  • 10614559104460 ()
MGEZLINK01

  • Surgical plume evacuation system
Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP2X9
In Commercial Distribution

  • 00690103199048 ()

  • 2 CM X 9 CM
DP2X9

  • Cardiovascular patch, animal-derived
Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP1X6
In Commercial Distribution

  • 00690103199031 ()

  • 1 CM X 6 CM
DP1X6

  • Cardiovascular patch, animal-derived
Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP08X8
In Commercial Distribution

  • 00690103199024 ()

  • 0.8 CM X 8 CM
DP08X8

  • Cardiovascular patch, animal-derived
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Drive Headstage
In Commercial Distribution

  • 07290114061520 ()
700-006000-00

  • Depth electrode
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906AB
In Commercial Distribution

  • 00840682121446 ()


  • Stationary gamma camera system
  • Full-body CT system
UFC GANTRY FINAL ASSEMBLY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3000SA
In Commercial Distribution

  • 00840682105286 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100AH
In Commercial Distribution

  • 00840682121194 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100AG
In Commercial Distribution

  • 00840682121187 ()


  • Stationary gamma camera system
  • Full-body CT system
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