Polypropylene Connector

Basic Information

• Brand Name: Polypropylene Connector
• Primary DI: 10381780034643
• Version / Model: 999412
• Catalog Number: 999412
• 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: 5
• Public Version Date: 2023-02-17
• Public Version Status: Update
• Public Device Record Key: 41237bfa-743e-4628-b960-2e0169d13527
• Distribution End Date: 2021-12-31

Device Description

Connectors are implantable accessories intended to be used with Integra hydrocephalus Valve Systems for connection between an implanted ventricular catheter or drainage catheter and a CSF Shunt System.

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: Yes
• MRI Safety: MR Safe
• 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
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	10381780034643	GS1
Secondary	M2729994121	HIBCC
Package	30381780034647	GS1	BOX	5	Not in Commercial Distribution	2021-12-31

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K921936	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			2.0mm O.D. x 1.0mm I.D.