Leksell Vantage Stereotactic System

Basic Information

• Brand Name: Leksell Vantage Stereotactic System
• Primary DI: 07340048304269
• Version / Model: 1519675
• Catalog Number: 1519664
• Company Name: Elekta Instrument AB
• Labeler DUNS: 507772663
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-16
• Public Version: 4
• Public Version Date: 2022-11-14
• Public Version Status: Update
• Public Device Record Key: f55c8225-67d7-4534-840e-514f5918b041

Device Description

FirmFix™ 3

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 Conditional
• 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
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
Package	07340048304252	GS1		20	In Commercial Distribution
Primary	07340048304269	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K171123	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			FirmFix™ size