Leksell Vantage Stereotactic System

Basic Information

• Brand Name: Leksell Vantage Stereotactic System
• Primary DI: 07340201501368
• Version / Model: 1040026
• Catalog Number: 1040027
• Company Name: Elekta Solutions AB
• Labeler DUNS: 353272181
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2024-06-18
• Public Version: 4
• Public Version Date: 2025-12-15
• Public Version Status: Update
• Public Device Record Key: 5a810aa0-188d-4a10-8598-2d8d401033fb

Device Description

FirmFix™ Ruler

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 Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HAW	Neurological stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32568	Neurological stereotactic surgery system	An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	07340048306065	GS1
Primary	07340201501368	GS1

Customer Contacts

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