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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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The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. The Contour-Flex Valve design includes a flat silicone membrane, which provides resistance to CSF flow. The Contour-Flex Valve is available in two sizes: Regular and Small. Both sizes are available in 3 pressure/flow characteristics ranges: low, medium, and high.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
CFSH
Not in Commercial Distribution

  • 10381780036814 ()
  • M272CFSH1 ()

  • High Pressure at 20ml/h: 12.7-18.0cmH2O
CFSH

  • Ventriculo-peritoneal/atrial shunt
The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. The Contour-Flex Valve design includes a flat silicone membrane, which provides resistance to CSF flow. The Contour-Flex Valve is available in two sizes: Regular and Small. Both sizes are available in 3 pressure/flow characteristics ranges: low, medium, and high.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
CFRM
Not in Commercial Distribution

  • 10381780036807 ()
  • M272CFRM1 ()

  • Medium Pressure at 20ml/h: 6.7-11.8cmH2O
CFRM

  • Ventriculo-peritoneal/atrial shunt
The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. The Contour-Flex Valve design includes a flat silicone membrane, which provides resistance to CSF flow. The Contour-Flex Valve is available in two sizes: Regular and Small. Both sizes are available in 3 pressure/flow characteristics ranges: low, medium, and high.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
CFRL
Not in Commercial Distribution

  • 10381780036791 ()
  • M272CFRL1 ()

  • Low Pressure at 20ml/h: 1.2-5.8cmH2O
CFRL

  • Ventriculo-peritoneal/atrial shunt
The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. The Contour-Flex Valve design includes a flat silicone membrane, which provides resistance to CSF flow. The Contour-Flex Valve is available in two sizes: Regular and Small. Both sizes are available in 3 pressure/flow characteristics ranges: low, medium, and high.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
CFRH
Not in Commercial Distribution

  • 10381780036784 ()
  • M272CFRH1 ()

  • High Pressure at 20ml/h: 12.7-18.0cmH2O
CFRH

  • Ventriculo-peritoneal/atrial shunt
Stimulation Lead, 65 cm length, Assembled and tray packed at OC, then sterilized and final packaged at OI.
MAINSTAY MEDICAL LIMITED
7M8165-005
In Commercial Distribution

  • 05391527772262 ()
8165

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Stimulation Lead, 65 cm length, Assembled, tray packed, and sterilized at Oscor Caribe, then final packaged at Oscor, Inc.
MAINSTAY MEDICAL LIMITED
7M8165-006
Not in Commercial Distribution

  • 05391527772279 ()
8165

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
3 HOLES LUMBOSACRAL PLATE Size 6 at 130°
MEDICREA INTERNATIONAL
B14032030
Not in Commercial Distribution

  • 03613720192978 ()


  • Spinal fixation plate, non-bioabsorbable
3 HOLES LUMBOSACRAL PLATE Size 6 at 115°
MEDICREA INTERNATIONAL
B14032015
Not in Commercial Distribution

  • 03613720192961 ()


  • Spinal fixation plate, non-bioabsorbable
3 HOLES LUMBOSACRAL PLATE Size 5 at 130°
MEDICREA INTERNATIONAL
B14031830
Not in Commercial Distribution

  • 03613720192954 ()


  • Spinal fixation plate, non-bioabsorbable
3 HOLES LUMBOSACRAL PLATE Size 5 at 115°
MEDICREA INTERNATIONAL
B14031815
Not in Commercial Distribution

  • 03613720192947 ()


  • Spinal fixation plate, non-bioabsorbable
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