Subdural Catheter

Basic Information

• Brand Name: Subdural Catheter
• Primary DI: 10381780034261
• Version / Model: 951310
• Catalog Number: 951310
• 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: 2023-02-09
• Public Version Status: Update
• Public Device Record Key: 0767e9a9-8641-471e-8c2d-6ed9ff884e3e
• Distribution End Date: 2021-08-01

Device Description

The Subdural Drainage Catheter is a radiopaque, silicone elastomer, drainage catheter consisting of a F8 tubing with a flattened, hollow cage at the distal tip. The Kit contains: 1 Subdural Catheter, 1 Introducing Rod, 1 Luer-lock Connector, 1 Right Angle Guide, 1 Butterfly Suture Clamp, 1 Subcutaneous Passer, 1 Disposable Drill Bit (5 mm) with adjustable stop and 1 Allen Wrench

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: 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: 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
61376	Intracerebral infusion/drainage catheter, long-term	A sterile, flexible tube intended to be surgically inserted through the skull for long-term (> 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it is typically used for measurement of intracranial pressure (ICP) and as part of a shunt system. It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, catheter holder); it does not include a sensor. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780034261	GS1
Secondary	M2729513101	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K974726	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			20cm Length x 2.7mm O.D. x 1.2mm I.D. (F8), 37cm Introducing Rod