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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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CSF Reservoir - 10381780034599

The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene needle-stop, and an F8 integrated connector. The CSF Reservoir can be provided alone. Other configurations include a right angle ventricular catheter (7 cm or 9 cm length) and a 15 cm introducing rod, or a 15 cm straight ventricular catheter and a right angle guide. The ventricular catheter features radiopaque length markings at 2, 4, 6, 8, 10 cm from the tip.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
999302
Not in Commercial Distribution

  • 10381780034599 ()
  • M2729993021 ()

  • Reservoir 0.6ml Internal Volume, Vent. Cath. 7cm Proximal Length x 5cm Distal Length x 2.7mm O.D. x 1.4mm I.D. (F8)
999302

  • Intracerebral infusion/drainage catheter, long-term

CSF Reservoir - 10381780034582

The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene needle-stop, and an F8 integrated connector. The CSF Reservoir can be provided alone. Other configurations include a right angle ventricular catheter (7 cm or 9 cm length) and a 15 cm introducing rod, or a 15 cm straight ventricular catheter and a right angle guide. The ventricular catheter features radiopaque length markings at 2, 4, 6, 8, 10 cm from the tip.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
999301
Not in Commercial Distribution

  • 10381780034582 ()
  • M2729993011 ()

  • 0.6ml Internal Volume
999301

  • Cranial port/reservoir

Burr Hole Reservoir - 10381780034575

The Burr Hole Reservoir is a component of a central nervous system (CNS) fluid shunt. It is used to connect the ventricular catheter to a silicone elastomer burr hole reservoir cap with integral side-arm leading to the valve tubing. It may also be used as a CSF reservoir with a ventricular catheter alone when a burr hole cap without side-arm is used. Configurations include 6.4 mm or 10 mm outer diameter reservoir and regular (2.5 mm) or shallow (0.8 mm) depth.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
999113
Not in Commercial Distribution

  • 10381780034575 ()
  • M2729991131 ()

  • 0.8mm Depth x 6.4mm Diam.
999113

  • Cranial port/reservoir

Burr Hole Reservoir - 10381780034568

The Burr Hole Reservoir is a component of a central nervous system (CNS) fluid shunt. It is used to connect the ventricular catheter to a silicone elastomer burr hole reservoir cap with integral side-arm leading to the valve tubing. It may also be used as a CSF reservoir with a ventricular catheter alone when a burr hole cap without side-arm is used. Configurations include 6.4 mm or 10 mm outer diameter reservoir and regular (2.5 mm) or shallow (0.8 mm) depth.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
999112
Not in Commercial Distribution

  • 10381780034568 ()
  • M2729991121 ()

  • 2.5mm Depth x 6.4mm Diam.
999112

  • Cranial port/reservoir

Burr Hole Reservoir - 10381780034551

The Burr Hole Reservoir is a component of a central nervous system (CNS) fluid shunt. It is used to connect the ventricular catheter to a silicone elastomer burr hole reservoir cap with integral side-arm leading to the valve tubing. It may also be used as a CSF reservoir with a ventricular catheter alone when a burr hole cap without side-arm is used. Configurations include 6.4 mm or 10 mm outer diameter reservoir and regular (2.5 mm) or shallow (0.8 mm) depth.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
999111
Not in Commercial Distribution

  • 10381780034551 ()
  • M2729991111 ()

  • Shallow Reservoir 0.8mm Depth x 6.4mm Diam., Cap Side Arm 2.7mm O.D. x 1.4mm I.D. (F8)
999111

  • Cranial port/reservoir

Burr Hole Reservoir - 10381780034544

The Burr Hole Reservoir is a component of a central nervous system (CNS) fluid shunt. It is used to connect the ventricular catheter to a silicone elastomer burr hole reservoir cap with integral side-arm leading to the valve tubing. It may also be used as a CSF reservoir with a ventricular catheter alone when a burr hole cap without side-arm is used. Configurations include 6.4 mm or 10 mm outer diameter reservoir and regular (2.5 mm) or shallow (0.8 mm) depth.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
999110
Not in Commercial Distribution

  • 10381780034544 ()
  • M2729991101 ()

  • Regular Reservoir 2.5mm Depth x 6.4mm Diam., Cap Side Arm 2.7mm O.D. x 1.4mm I.D. (F8)
999110

  • Cranial port/reservoir

Integral Ventricular Reservoir - 10381780034513

The Integra Ventricular Antechamber is a radiopaque component of a Cerebrospinal Fluid (CSF) shunt. The Ventricular Antechamber Kit includes a Ventricular Antechamber, a separate Straight Ventricular Catheter, featuring radiopaque Length Markings, a Right Angle Guide and a Wire Introducer. Other configurations are available: Ventricular Antechamber alone; Ventricular Antechamber with an integrated Right Angle Ventricular Catheter (Integral Ventricular Reservoir).
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
999017
Not in Commercial Distribution

  • 10381780034513 ()
  • M2729990171 ()

  • Vent. Antechamber 0.3ml. Internal Volume, Vent. Cath. 7cm Length x 2.7mm O.D. x 1.4mm I.D. (F8)
999017

  • Intracerebral infusion/drainage catheter, long-term

Integral Ventricular Reservoir - 10381780034506

The Integra Ventricular Antechamber is a radiopaque component of a Cerebrospinal Fluid (CSF) shunt. The Ventricular Antechamber Kit includes a Ventricular Antechamber, a separate Straight Ventricular Catheter, featuring radiopaque Length Markings, a Right Angle Guide and a Wire Introducer. Other configurations are available: Ventricular Antechamber alone; Ventricular Antechamber with an integrated Right Angle Ventricular Catheter (Integral Ventricular Reservoir).
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
999016
Not in Commercial Distribution

  • 10381780034506 ()
  • M2729990161 ()

  • Vent. Antechamber 0.3ml. Internal Volume, Vent. Cath. 4cm Length x 2.7mm O.D. x 1.4mm I.D. (F8)
999016

  • Intracerebral infusion/drainage catheter, long-term

Integral Ventricular Reservoir - 10381780034490

The Integra Ventricular Antechamber is a radiopaque component of a Cerebrospinal Fluid (CSF) shunt. The Ventricular Antechamber Kit includes a Ventricular Antechamber, a separate Straight Ventricular Catheter, featuring radiopaque Length Markings, a Right Angle Guide and a Wire Introducer. Other configurations are available: Ventricular Antechamber alone; Ventricular Antechamber with an integrated Right Angle Ventricular Catheter (Integral Ventricular Reservoir).
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
999015
Not in Commercial Distribution

  • 10381780034490 ()
  • M2729990151 ()

  • Vent. Antechamber 0.3ml. Internal Volume, Vent. Cath. 3cm Length x 2.7mm O.D. x 1.4mm I.D. (F8)
999015

  • Intracerebral infusion/drainage catheter, long-term

Ventricular Antechamber - 10381780034483

The Integra Ventricular Antechamber is a radiopaque component of a Cerebrospinal Fluid (CSF) shunt. The Ventricular Antechamber Kit includes a Ventricular Antechamber, a separate Straight Ventricular Catheter, featuring radiopaque Length Markings, a Right Angle Guide and a Wire Introducer. Other configurations are available: Ventricular Antechamber alone; Ventricular Antechamber with an integrated Right Angle Ventricular Catheter (Integral Ventricular Reservoir).
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
999014
Not in Commercial Distribution

  • 10381780034483 ()
  • M2729990141 ()

  • Vent. Antechamber 0.3ml Internal Volume, Right Angle Guide 4.9mm Diam., Straight Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8)
999014

  • Intracerebral infusion/drainage catheter, long-term
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