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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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Novus™ - 10381780071723

Novus™ Mini Valve
Integra Lifesciences Corporation
NL8509011
In Commercial Distribution

  • 10381780071723 ()
  • M269NL85090111 ()

  • Length: 31 mm; Width: 13 mm; Profile Height: 6 mm
NL8509011

  • Cerebrospinal fluid shunt valve

Novus™ - 10381780071716

Novus™ Valve
Integra Lifesciences Corporation
NL8509010
In Commercial Distribution

  • 10381780071716 ()
  • M269NL8509010 ()

  • Length: 37 mm; Width: 16.7 mm; Profile Height: 8 mm
NL8509010

  • Cerebrospinal fluid shunt valve

Spetzler™ - 10381780071631

Spetzler™ Lumbar Peritoneal Flushing Reservoir
Integra Lifesciences Corporation
NL8507460
In Commercial Distribution

  • 10381780071631 ()
  • M269NL85074601 ()

  • Reservoir length: 2.9cm; Inlet and Outlet Tube: 0.7mm ID x 1.5mm OD; Height 1.2cm
NL8507460

  • Cerebrospinal fluid shunt valve

Spetzler™ - 10381780071617

Spetzler™ In-Line Valve
Integra Lifesciences Corporation
NL8507421
In Commercial Distribution

  • 10381780071617 ()
  • M269NL85074211 ()

  • Total Length: 3.2 cm; Height 5mm
NL8507421

  • Cerebrospinal fluid shunt valve

Integra Essential Shunt Kit Flat Bottom Design - 10381780071594

The Integra Essential Shunt Kit-Flat Bottom Design is designed to deliver CSF from the ventricles of the brain to the peritoneal cavity. Each kit contains one CSF flushing reservoir with attached 120cm kink-resistant striped peritoneal tubing. The CSF flow control valve is located inside the peritoneal tubing immediately distal to the reservoir. One 18cm ventricular catheter with stylet and one right-angle ventricular catheter guide are also included.
Integra Lifesciences Corporation
NL8504120
Not in Commercial Distribution

  • 10381780071594 ()
  • M269NL85041201 ()

  • 120cm tubing, 18cm ventricular catheter
NL8504120

  • Ventriculoperitoneal shunt

Integra Essential Shunt Kit - 10381780071570

HS ESSENTIAL CSF SHUNT SYSTEM The Integra Essential Shunt Kit- Burr Hole Design contains one 16mm CSF Flow Control Valve, one 18cm Ventricular Catheter with stylet and one 120cm open-ended peritoneal catheter. The CSF flow control valve, designed for placement in a formal burr hole, is a spherically shaped, silicone elastomer device used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The valve incorporates an internal medium pressure diaphragm for proximal control of CSF flow. The device also provides one-way flow control. The kit is designed to deliver CSF from the ventricles of the brain to the peritoneal cavity.
Integra Lifesciences Corporation
NL8504111
Not in Commercial Distribution

  • 10381780071570 ()
  • M269NL85041111 ()

  • 16mm CSF Flow Control Valve. 18cm ventricular catheter with stylet. 120cm open-ended peritoneal catheter.
NL8504111

  • Ventriculoperitoneal shunt

Integra Essential Shunt Kit - 10381780071563

HS ESSENTIAL CSF SHUNT SYSTEM The Integra Essential Shunt Kit- Burr Hole Design contains one 16mm CSF Flow Control Valve, one 18cm Ventricular Catheter with stylet and one 120cm open-ended peritoneal catheter. The CSF flow control valve, designed for placement in a formal burr hole, is a spherically shaped, silicone elastomer device used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The valve incorporates an internal low pressure diaphragm for proximal control of CSF flow. The device also provides one-way flow control. The kit is designed to deliver CSF from the ventricles of the brain to the peritoneal cavity.
Integra Lifesciences Corporation
NL8504110
Not in Commercial Distribution

  • 10381780071563 ()
  • M269NL85041101 ()

  • 16mm CSF Flow Control Valve. 18cm ventricular catheter with stylet. 120cm open-ended peritoneal catheter.
NL8504110

  • Ventriculoperitoneal shunt

Integra® - 10381780071549

Integra® Pudenz Flushing Valve Pudenz Flushing Valve with Anti-Siphon Device Burr Hole Design with Anti-Siphon Device
Integra Lifesciences Corporation
NL8501415
In Commercial Distribution

  • 10381780071549 ()
  • M269NL85014151 ()

  • 12mm Inlet Integral Connector: 1.1mm I.D. x 1.9mm O.D; Outlet Integral Connector: 1.1mm I.D. x 1.9mm O.D.
NL8501415

  • Cerebrospinal fluid shunt valve

Integra® - 10381780071525

Integra® Pudenz Flushing Valve Pudenz Flushing Valve with Anti-Siphon Device Burr Hole Design with Anti-Siphon Device
Integra Lifesciences Corporation
NL8501413
In Commercial Distribution

  • 10381780071525 ()
  • M269NL85014131 ()

  • 12mm Inlet Integral Connector: 1.1mm I.D. x 1.9mm O.D; Outlet Integral Connector: 1.1mm I.D. x 1.9mm O.D.
NL8501413

  • Cerebrospinal fluid shunt valve

Integra® - 10381780071501

Integra® Pudenz Flushing Valve Pudenz Flushing Valve with Anti-Siphon Device Burr Hole Design with Anti-Siphon Device
Integra Lifesciences Corporation
NL8501411
In Commercial Distribution

  • 10381780071501 ()
  • M269NL85014111 ()

  • 12mm Inlet Integral Connector: 1.1mm I.D. x 1.9mm O.D; Outlet Integral Connector: 1.1mm I.D. x 1.9mm O.D.
NL8501411

  • Cerebrospinal fluid shunt valve
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