Right Angle Guide 991002

GUDID 10381780034438

The Right Angle Guide is a component of Integra NeuroSciences Hydrocephalus Valve Systems. It is used to form a right angle bend in a F7, F8 ventricular catheter at the burr hole (diameter 5 mm). Implanted materials are silicone elastomer impregnated with barium sulfate.

INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Intracranial catheter holder Intracranial catheter holder Intracranial catheter holder Intracranial catheter holder Intracranial catheter holder Intracranial catheter holder Intracranial catheter holder Intracranial catheter holder Intracranial catheter holder Intracranial catheter holder Intracranial catheter holder Intracranial catheter holder Intracranial catheter holder Intracranial catheter holder Intracranial catheter holder Intracranial catheter holder Intracranial catheter holder

• Primary Device ID: 10381780034438
• NIH Device Record Key: cdae2687-1378-47f2-bb74-c2041d2d6f74
• Commercial Distribution Discontinuation: 2021-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Right Angle Guide
• Version Model Number: 991002
• Catalog Number: 991002
• Company DUNS: 531408342
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780034438 [Primary]
GS1	30381780034432 [Package]; Package: BOX [5 Units]; Discontinued: 2021-12-31; Not in Commercial Distribution
HIBCC	M2729910021 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K913842

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: 2023-02-17
• Device Publish Date: 2015-10-01

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• 10381780034605 - CSF Reservoir: 2024-03-18 The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene needle-stop, and an F8 integrated c
• 10381780034612 - CSF Reservoir: 2024-03-18 The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene needle-stop, and an F8 integrated c
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• M27217185C161 - Integra®: 2024-03-18 The female electrode connecting cable is a reusable device used to connect the Integra® Cortical and Depth electrodes to an EEG