VELYS

Basic Information

• Brand Name: VELYS
• Primary DI: 10603295520139
• Version / Model: 4515-70-012
• Catalog Number: 451570012
• Company Name: DEPUY (IRELAND)
• Labeler DUNS: 989365556
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-18
• Public Version: 4
• Public Version Date: 2023-01-20
• Public Version Status: Update
• Public Device Record Key: 1e6a778b-904f-4eb4-82d7-f3837efd4dc2
• Distribution End Date: 2021-08-23

Device Description

VELYS Robotic-Assisted Solution PLANE TOOL - KNEE

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: 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: 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
OLO	Orthopedic stereotaxic instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45170	Stereotactic surgery system probe, single-use	A slender, rod-like, hand-held manual surgical instrument intended for use during image-guided surgery (e.g., neurosurgical or orthopaedic surgery procedures) to accurately position implantable devices (e.g., shunts), or to correlate the position of its tip with that of a targeted tissue of interest in a patient so the tissue area is precisely identified with respect to diagnostic images stored in the stereotactic surgery system. It is made of metal. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10603295520139	GS1

Customer Contacts

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