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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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Contour-Flex Valve and Shunt System - 10381780457510

Contour-Flex Valve System, Small, Low Pressure for ventricular shunting of cerebrospinal fluid.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
16254
Not in Commercial Distribution


  • 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 - 10381780457381

Contour-Flex Valve System, Regular, High Pressure for ventricular shunting of cerebrospinal fluid.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
11856
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)
11856

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780457374

Contour-Flex Valve System, Regular, Medium Pressure for ventricular shunting of cerebrospinal fluid.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
11855
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)
11855

  • Ventriculo-peritoneal/atrial shunt

Contour-Flex Valve and Shunt System - 10381780457367

Contour-Flex Valve System, Regular, Low Pressure for ventricular shunting of cerebrospinal fluid.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
11854
Not in Commercial Distribution


  • 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

Infinity-Lock Button System - 05060267131836

No Description
XIROS LTD
102-1089
In Commercial Distribution

  • 05060267131836 ()
n/a

  • Acromioclavicular joint stabilization implant
  • Cannulated surgical drill bit, single-use

NA - 05415067037275

Suture Sleeve
ST. JUDE MEDICAL, INC.
DS2A088
In Commercial Distribution

  • 05415067037275 ()

  • Catheter Gauge: 6.0000 French
DS2A088

  • Implantable electrical stimulation lead suture sleeve

INTERSTIM® - 00643169864450

LEAD 3889-41 ISTIM QUAD SNS 41CM US EMAN
MEDTRONIC, INC.
3889-41
In Commercial Distribution

  • 00643169864450 ()

  • Length: 41.0 Centimeter


  • Sacral plexus implantable incontinence-control electrical stimulation system electrode

INTERSTIM® - 00643169864443

LEAD 3889-33 ISTIM QUAD SNS 33CM US EMAN
MEDTRONIC, INC.
3889-33
Not in Commercial Distribution

  • 00643169864443 ()

  • Length: 33.0 Centimeter


  • Sacral plexus implantable incontinence-control electrical stimulation system electrode

INTERSTIM® - 00643169864436

LEAD 3889-28 ISTIM QUAD SNS 28CM US EMAN
MEDTRONIC, INC.
3889-28
Not in Commercial Distribution

  • 00643169864436 ()

  • Length: 28.0 Centimeter


  • Sacral plexus implantable incontinence-control electrical stimulation system electrode

SJM™ - 05414734506823

SLIT SUTURE SLEEVE (4.3 - 4.7F)
ST. JUDE MEDICAL, INC.
DSA0006
In Commercial Distribution

  • 05414734506823 ()

  • Catheter Gauge: 4.5 French
DSA0006

  • Implantable electrical stimulation lead suture sleeve
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