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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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Piccolo Composite Nailing System - 07290110201494

Lag screw for use with proximal femur nails.
CARBOFIX ORTHOPEDICS LTD
Lag Screw
In Commercial Distribution

  • 07290110201494 ()

  • Outer Diameter: 10.4 Millimeter
  • Length: 80 Millimeter
TPPFLS10080

  • Femoral neck fixation sliding bone screw

Fixion Nailing System - 07290109331744

Hip peg used with the Fixion proximal femur intramedullary nail (intended for use in the fixation of proximal fractures in the femur).
CARBOFIX ORTHOPEDICS LTD
Proximal Femur Hip Peg
Not in Commercial Distribution

  • 07290109331744 ()

  • Length: 120 Millimeter
  • Insertion Diameter: 8 Millimeter
  • Expanded Diameter: 12 Millimeter
  • Proximal Diameter: 8 x 10 Millimeter
4418120

  • Femoral neck fixation sliding bone screw

Contour-Flex Valve and Shunt System - 10381780033141

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)
16256
Not in Commercial Distribution

  • 10381780033141 ()
  • M272162561 ()

  • High Pressure at 20ml/h: 12.7-18.0cmH2O, Outlet Tubing 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8)
16256

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780033134

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)
16255
Not in Commercial Distribution

  • 10381780033134 ()
  • M272162551 ()

  • Medium Pressure at 20ml/h: 6.7-11.8cmH2O, Outlet Tubing 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8)
16255

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780033127

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)
16254
Not in Commercial Distribution

  • 10381780033127 ()
  • M272162541 ()

  • Low Pressure at 20ml/h: 1.2-5.8cmH2O, Outlet Tubing 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8)
16254

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780032885

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)
11856
Not in Commercial Distribution

  • 10381780032885 ()
  • M272118561 ()

  • High Pressure at 20ml/h: 12.7-18.0cmH2O, Outlet Tubing 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8)
11856

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780032878

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)
11855
Not in Commercial Distribution

  • 10381780032878 ()
  • M272118551 ()

  • Medium Pressure at 20ml/h: 6.7-11.8cmH2O, Outlet Tubing 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8)
11855

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780032861

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)
11854
Not in Commercial Distribution

  • 10381780032861 ()
  • M272118541 ()

  • Low Pressure at 20ml/h: 1.2-5.8cmH2O, Outlet Tubing 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8)
11854

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780457534

Contour-Flex Valve System, Small, High Pressure for ventricular shunting of cerebrospinal fluid.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
16256
Not in Commercial Distribution


  • High Pressure at 20ml/h: 12.7-18.0cmH2O, Outlet Tubing 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8)
16256

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780457527

Contour-Flex Valve System, Small, Medium Pressure for ventricular shunting of cerebrospinal fluid.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
16255
Not in Commercial Distribution


  • Medium Pressure at 20ml/h: 6.7-11.8cmH2O, Outlet Tubing 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8)
16255

  • Ventriculo-peritoneal/atrial shunt
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