LimiTorr™

Basic Information

• Brand Name: LimiTorr™
• Primary DI: 10381780112228
• Version / Model: INS400L
• Catalog Number: INS400L
• 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: 2020-12-15
• Public Version Status: Update
• Public Device Record Key: bb15d656-6374-4047-b9c8-04a24db7ae99

Device Description

The Pole Mount Laser Level device is provided with mounting bracket for use with Integra Pole Mount Assemblies. The Pole Mount Laser provides alignment for the External CSF Drainage and Monitoring Systems. These systems are used for draining CSF from an intraventricular catheter or lumbar catheter to an external ventricular drainage system.

Device Characteristics

• Single Use: No
• 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 Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
61798	Ventricular cerebrospinal fluid drainage catheterization kit	A collection of sterile devices intended for short-term access to the brain ventricles to drain cerebrospinal fluid (CSF), and/or other fluids of similar physical characteristics, as a means of reducing CSF volume and intracranial pressure (ICP). It includes an intracerebral infusion/drainage catheter and devices intended for catheter insertion (e.g. stylet) and CSF collection (e.g., drip chamber, drainage bag, tubing set). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780112228	GS1
Secondary	M269INS400L1	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K062599	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.