Integra Essential Shunt Kit

Basic Information

• Brand Name: Integra Essential Shunt Kit
• Primary DI: 10381780071587
• Version / Model: NL8504112
• Catalog Number: NL8504112
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-22
• Public Version: 7
• Public Version Date: 2022-10-10
• Public Version Status: Update
• Public Device Record Key: c2f23b06-0a31-4cf5-b6fb-a5a01022c92c
• Distribution End Date: 2018-01-01

Device Description

HS ESSENTIAL CSF SHUNT SYSTEM The Integra Essential Shunt Kit- Burr Hole Design contains one 16mm CSF Flow Control Valve, one 18cm Ventricular Catheter with stylet and one 120cm open-ended peritoneal catheter. The CSF flow control valve, designed for placement in a formal burr hole, is a spherically shaped, silicone elastomer device used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The valve incorporates an internal high pressure diaphragm for proximal control of CSF flow. The device also provides one-way flow control. The kit is designed to deliver CSF from the ventricles of the brain to the peritoneal cavity.

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 Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
45694	Ventriculoperitoneal shunt	An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the brain ventricles to the peritoneal cavity, where it can be absorbed into the body, as a treatment for increased intracranial pressure (e.g., caused by hydrocephalus). It typically consists of three main connected parts: 1) an intracerebral ventricular catheter through which CSF flows; 2) a mechanical shunt valve that typically opens at a pre-set pressure; and 3) a peritoneal catheter that channels the CSF to the peritoneal cavity. It is made of plastic and silicone materials; disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780071587	GS1
Secondary	M269NL85041121	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K153041	000
K973525	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			16mm CSF Flow Control Valve. 18cm ventricular catheter with stylet. 120cm open-ended peritoneal catheter.