Integra NeuroSciences Connector

Basic Information

• Brand Name: Integra NeuroSciences Connector
• Primary DI: 10381780071211
• Version / Model: NL75121S06
• Catalog Number: NL75121S06
• 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: 5
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: cb34707f-78d9-4acb-8cfc-25081c351763

Device Description

The lumbar-peritoneal shunt connector is manufactured from stainless steel material. A reduced diameter tip facilitates insertion of a connector into a catheter tube. A single groove is considered standard and is located near each connector end to accommodate a ligature. This type of end is inserted into flushing devices and all catheters that are not spring-reinforced. A threaded (or multi-grooved) end is designed for insertion into spring-reinforced catheters, ventricular or peritoneal models.

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: Labeling does not contain MRI Safety Information
• 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
47515	Cerebrospinal fluid shunt connector	An implantable device intended to create a fluid path connection between components of a cerebrospinal fluid (CSF) shunt assembly (e.g., lumbar and/or peritoneal catheters of a ventriculoperitoneal or lumboperitoneal shunt), designed to remove excess cerebrospinal fluid from around the central nervous system especially in the treatment of hydrocephalus. It is typically made of plastic or metal and is available in various designs (L-, Y- or cross-shaped, straight).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780071211	GS1
Secondary	M269NL75121S061	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K811288	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0.635mm ID x 1.1938mm OD (all dimensions nominal)

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid contaminants such as lint, fingerprints, or talc.