Burr Hole Reservoir

Basic Information

• Brand Name: Burr Hole Reservoir
• Primary DI: 10381780034360
• Version / Model: 955141
• Catalog Number: 955141
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• Labeler DUNS: 531408342
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-01
• Public Version: 4
• Public Version Date: 2023-02-09
• Public Version Status: Update
• Public Device Record Key: 139e87ef-be17-4393-851b-0a17db3e2075
• Distribution End Date: 2019-12-31

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JXG	Shunt, central nervous system and components	Neurology	882.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61375	Cranial port/reservoir	A sterile, implantable chamber intended to be connected to an intracerebral catheter for infusion/injection of materials (e.g., chemotherapeutic agents, radioisotopes) into the brain (e.g., cerebral ventricles, cystic tumours, tumour cavities); it may also be used for drainage of cerebrospinal fluid (CSF) from the ventricles and as part of a ventriculo-peritoneal/atrial shunt system. The device is implanted subcutaneously and materials infused/injected with a needle via hypodermic puncture flow into the target site through the connected catheter. It is typically a bulb-shaped device made of plastic material (e.g., polypropylene, silicone). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780034360	GS1
Secondary	M2729551411	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K152897	000
K861377	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Shallow Reservoir 0.8mm Depth x 10mm Diam., Cap Side Arm 2.7mm O.D. x 1.4mm I.D. (F8)