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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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osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacrylate-n-vinylpyrrolidone-co-polymer) using the osmotic principle to expand physiological tissue space due to the absorption of body fluid from the surrounding tissues. The osmed Sphere Expanders are used for expansion of the orbita at congenital anophthalmia and microphthalmia.
Osmed GmbH
3.0ml
In Commercial Distribution

  • EOSM35273001 ()
352-7300

  • Skin-port tissue expander
osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacrylate-n-vinylpyrrolidone-co-polymer) using the osmotic principle to expand physiological tissue space due to the absorption of body fluid from the surrounding tissues. The osmed Sphere Expanders are used for expansion of the orbita at congenital anophthalmia and microphthalmia.
Osmed GmbH
2.0ml
In Commercial Distribution

  • EOSM35272001 ()
352-7200

  • Skin-port tissue expander
osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacrylate-n-vinylpyrrolidone-co-polymer) using the osmotic principle to expand physiological tissue space due to the absorption of body fluid from the surrounding tissues. The osmed Sphere Expanders are used for expansion of the orbita at congenital anophthalmia and microphthalmia.
Osmed GmbH
1.0ml
In Commercial Distribution

  • EOSM35271001 ()
352-7100

  • Skin-port tissue expander
The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be used in cervical spinal fusion surgery for skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level.
Providence Medical Technology, Inc.
PD-31-200
In Commercial Distribution

  • 00852776006003 ()
PD-31-200

  • Implantable cervical facet joint distractor
The CAVUX Cervical Cage-T is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be used in cervical spinal fusion surgery for skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level.
Providence Medical Technology, Inc.
PD-31-100
In Commercial Distribution

  • 00852776006010 ()
PD-31-100

  • Metallic spinal interbody fusion cage
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)
14163
Not in Commercial Distribution

  • 10381780033066 ()
  • M272141631 ()

  • High Pressure at 20ml/h: 12.7-18.0cmH2O, Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Outlet Tubing 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Right Angle Guide 4.9mm Diam.
14163

  • 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)
14162
Not in Commercial Distribution

  • 10381780033059 ()
  • M272141621 ()

  • Medium Pressure at 20ml/h: 6.7-11.8cmH2O, Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Outlet Tubing 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Right Angle Guide 4.9mm Diam.
14162

  • 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)
14161
Not in Commercial Distribution

  • 10381780033042 ()
  • M272141611 ()

  • Low Pressure at 20ml/h: 1.2-5.8cmH2O, Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Outlet Tubing 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Right Angle Guide 4.9mm Diam.
14161

  • 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)
14087
Not in Commercial Distribution

  • 10381780033035 ()
  • M272140871 ()

  • 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), Right Angle Guide 4.9mm Diam.
14087

  • 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)
14086
Not in Commercial Distribution

  • 10381780033028 ()
  • M272140861 ()

  • 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), Right Angle Guide 4.9mm Diam.
14086

  • Ventriculo-peritoneal/atrial shunt
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