Integra Neuroview Endoscopic Ventricular Catheter NL8501328

GUDID 10381780072300

NEUROVIEW ENDOSCOPIC VENT CATH The Integra Neuroview ventricular catheter is designed to be used with a neurosurgical endoscope. The endoscope is used when a physician wishes to place a catheter’s tip at a specific intraventricular location or to view intraventricular anatomy. The slit-tip of the catheter protects the endocscope from debris buildup during insertion, but allows intraventricular viewing to assist in optimal catheter placement. The Neuroview ventricular catheter is manufactured from a high durometer silicone elastomer, which helps resist kinking and occlusion caused by the bending or twisting of the catheter. A stripe, made of barium sulfate impregnated silicone elastomer, is imbedded in the wall of the catheter. The stripe provides a catheter which is radiopaque throughout its entire length, while keeping barium sulfate away from the surface of the catheter and allowing visual observation of flow through the catheter during implantation. The catheter has multiple small perforations near the tip to facilitate drainage of CSF and to help reduce clogging. The extreme tip is closed to help prevent particulate matter from entering the tubing during insertion. The catheter has graduation markers to allow the surgeon to measure the length of tubing placed within the ventricle during surgery.

Integra Lifesciences Corporation

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• Primary Device ID: 10381780072300
• NIH Device Record Key: 35d032be-f2fc-4633-915a-2908bf995e60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra Neuroview Endoscopic Ventricular Catheter
• Version Model Number: NL8501328
• Catalog Number: NL8501328
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780072300 [Primary]
HIBCC	M269NL85013281 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153041

FDA Product Code

• JXG: Shunt, central nervous system and components

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-22
• Device Publish Date: 2015-09-22

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