VELYS

Basic Information

• Brand Name: VELYS
• Primary DI: 10705034643380
• Version / Model: 451611041
• Catalog Number: 451611041
• Company Name: Medos International Sàrl
• Labeler DUNS: 482661753
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-28
• Public Version: 1
• Public Version Date: 2025-04-07
• Public Version Status: New
• Public Device Record Key: cb606539-3e67-4170-99b9-37f2f48fb774

Device Description

VELYS SPINE SKULL FRAME ADAPTOR NARROW

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Lot/Batch Number: No
• 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
OLO	Orthopedic stereotaxic instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47436	Surgical optical-tracking spatial marker holder	A component of a surgical navigation and/or device tracking system (e.g., computer-assisted neurosurgical ultrasound navigation system, surgical microscope with tracking camera) intended to be used preoperatively and/or intraoperatively as a localizer/holder for optical spatial markers (e.g., reflective marker spheres) that are attached to it prior to use. It can be attached to the distal end of an ultrasound transducer (US probe), neurosurgical instrument, hand-held pointer manipulated by the surgeon, or a patient reference point (e.g., head clamp), and is used as part of the tracking system to provide the correct position of the surgical devices and patient. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10705034643380	GS1