INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Address:2905 ROUTE DES DOLINES,Sophia Antipolis CEDEX Alpes-Maritimes,FR

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Device Description : The Integra NeuroSciences Peritoneal Catheter is a 91 cm silicone elastomer bari The Integra NeuroSciences Peritoneal Catheter is a 91 cm silicone elastomer barium sulfate striped tubing. Numbered length markers are located 5, 10, 15, 20, 25 and 30 cm from the distal end to assist catheter placement. The distal end of the catheter has four staggered rows of 5.5-mm slits, which are not easily visible. If the distal outlet hole of the catheter becomes obstructed, the slits open for drainage.

Device Class :

Duns Number: 531408342

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The non sterile Peña Muscle Stimulator Bipolar Probe (PS2P) is a 17 cm long reus The non sterile Peña Muscle Stimulator Bipolar Probe (PS2P) is a 17 cm long reusable probe for use in the surgical treatment of high and low anorectal malformation. The probe has a 260 cm cord with two electrically shrouded banana plugs for attachment to the Peña Muscle Stimulator (PS2, sold separately). The probe tip consists of two gold plated polished wire probes, 0.8 mm diameter and separated by 1.8 mm. The wire probes function as the bipolar stimulus electrodes when the PS2P Probe is connected to the PS2 Stimulator.

Device Class : 2

Duns Number: 531408342

Premarket Exempt : Yes

Product Code : IPF

Prescription Use : Yes

Device Count : 1

Device Description : The Integra NeuroSciences Ventricular Catheter is a 25 cm silicone elastomer tub The Integra NeuroSciences Ventricular Catheter is a 25 cm silicone elastomer tubing with full barium impregnation. Numbered length markers are located 5 and 10 cm from the proximal end. Length marker dots are located at 1 cm increments 3 to 14 cm from the proximal end. The proximal end presents fourty (40) flow holes. The proximal tip is constructed of molded, barium sulfate impregnated silicone to provide smooth, consistent end, which aid catheter placement. A stainless steel stylet and a right angle guide are provided.

Device Class :

Duns Number: 531408342

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The female electrode connecting cable is a reusable device used to connect the I The female electrode connecting cable is a reusable device used to connect the Integra® Cortical and Depth electrodes to an EEG monitor through a Cam Lock cylindrical Connector. It has 32 gold plated connector pins corresponding to the electrode Contacts, to be plugged into the corresponding EEG Monitor input channels.

Device Class : 2

Duns Number: 531408342

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : Licox® VK52 Parenchymal Probe Guide is used for tunneling Licox CC1P1 subcutane Licox® VK52 Parenchymal Probe Guide is used for tunneling Licox CC1P1 subcutaneously under the scalp. It contains: Parenchymal Probe Guide, Drill Bit, Drill stop with set screw, Hex wrench,

Device Class : 2

Duns Number: 531408342

Premarket Exempt : No

Product Code : GWM

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The Camino Flex Ventricular Intracranial Pressure Monitoring Kit is indicated wh The Camino Flex Ventricular Intracranial Pressure Monitoring Kit is indicated when direct and continuous intraventricular intracranial pressure monitoring and cerebrospinal fluid drainage are required. The catheter is embedded with a strain gauge pressure transducer.The system is designed for no more than five days of continuous monitoring.

Device Class : 2

Duns Number: 531408342

Premarket Exempt : No

Product Code : GWM

Prescription Use : Yes

Device Count : 1

Device Description : Contour-Flex Valve System, Regular, Low Pressure for ventricular shunting of cer Contour-Flex Valve System, Regular, Low Pressure for ventricular shunting of cerebrospinal fluid.

Device Class : 2

Duns Number: 531408342

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

Device Description : Contour-Flex Valve System, Regular, Medium Pressure for ventricular shunting of Contour-Flex Valve System, Regular, Medium Pressure for ventricular shunting of cerebrospinal fluid.

Device Class : 2

Duns Number: 531408342

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

Device Description : Contour-Flex Valve System, Regular, High Pressure for ventricular shunting of ce Contour-Flex Valve System, Regular, High Pressure for ventricular shunting of cerebrospinal fluid.

Device Class : 2

Duns Number: 531408342

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

Device Description : Contour-Flex Valve System, Small, Low Pressure for ventricular shunting of cereb Contour-Flex Valve System, Small, Low Pressure for ventricular shunting of cerebrospinal fluid.

Device Class : 2

Duns Number: 531408342

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1