Burr Hole Reservoir 955111

GUDID 10381780034322

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)

Cranial port/reservoir

• Primary Device ID: 10381780034322
• NIH Device Record Key: acef2736-fda0-4256-8c68-ef3f42f3b830
• Commercial Distribution Discontinuation: 2019-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Burr Hole Reservoir
• Version Model Number: 955111
• Catalog Number: 955111
• Company DUNS: 531408342
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	10381780034322 [Primary]
HIBCC	M2729551111 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152897

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: 2023-02-09
• Device Publish Date: 2015-10-01

On-Brand Devices [Burr Hole Reservoir]

• 10381780034575: The Burr Hole Reservoir is a component of a central nervous system (CNS) fluid shunt. It is used
• 10381780034568: The Burr Hole Reservoir is a component of a central nervous system (CNS) fluid shunt. It is used
• 10381780034551: The Burr Hole Reservoir is a component of a central nervous system (CNS) fluid shunt. It is used
• 10381780034544: The Burr Hole Reservoir is a component of a central nervous system (CNS) fluid shunt. It is used
• 10381780034384: The Burr Hole Reservoir is a component of a central nervous system (CNS) fluid shunt. It is used
• 10381780034377: The Burr Hole Reservoir is a component of a central nervous system (CNS) fluid shunt. It is used
• 10381780034360: The Burr Hole Reservoir is a component of a central nervous system (CNS) fluid shunt. It is used
• 10381780034353: The Burr Hole Reservoir is a component of a central nervous system (CNS) fluid shunt. It is used
• 10381780034346: The Burr Hole Reservoir is a component of a central nervous system (CNS) fluid shunt. It is used
• 10381780034339: The Burr Hole Reservoir is a component of a central nervous system (CNS) fluid shunt. It is used
• 10381780034322: The Burr Hole Reservoir is a component of a central nervous system (CNS) fluid shunt. It is used
• 10381780034315: The Burr Hole Reservoir is a component of a central nervous system (CNS) fluid shunt. It is used