Integra®

Basic Information

• Brand Name: Integra®
• Primary DI: 10381780071495
• Version / Model: NL8501410
• Catalog Number: NL8501410
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-22
• Public Version: 7
• Public Version Date: 2023-05-16
• Public Version Status: Update
• Public Device Record Key: 28474797-8781-4361-b656-6a9967354590

Device Description

Integra® Pudenz Flushing Valve Pudenz Flushing Valve with Anti-Siphon Device Burr Hole Design with Anti-Siphon Device

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• 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
35965	Cerebrospinal fluid shunt valve	An implantable device intended to function as part of a lumboperitoneal, ventriculoperitoneal or ventriculoatrial shunt to regulate the pressure and flow level of cerebrospinal fluid (CSF) from the lumbar spine or brain to the peritoneum/heart right atrium in the management of increased intracranial pressure (e.g., caused by hydrocephalus). It consists of a mechanical valve with catheter connections and is made of synthetic polymer and/or metallic materials; it does not incorporate a port or reservoir. It typically opens at a pre-set pressure and may be non-invasively adjusted using a dedicated programmer.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780071495	GS1
Secondary	M269NL85014101	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K153041	000
K760502	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			16mm Inlet Integral Connector: 1.1mm I.D. x 1.9mm O.D; Outlet Integral Connector: 1.1mm I.D. x 1.9mm O.D.