Endovascular Laser Vein System (ELVeS®) Kit

Basic Information

• Brand Name: Endovascular Laser Vein System (ELVeS®) Kit
• Primary DI: 04049089100283
• Version / Model: ELVeS® Radial® Kit 6Fx7cm
• Catalog Number: 101235
• Company Name: Ceram Optec SIA
• Labeler DUNS: 506069240
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-31
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 31275c58-b930-43de-be81-8cf3f4d58860

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47535	Varicose vein lasing procedure kit	A collection of sterile devices and materials designed to perform percutaneous laser treatment of varicose veins and varicosities associated with reflux in the superficial veins of the leg. It typically contains an entry needle, a laser fibre, an introducer sheath, a catheter, a guidewire, a dilator, and connectors to facilitate connection to a laser (e.g., a diode laser) and provide a pathway for the laser energy into the section(s) of the vein to be treated. This device does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04049089200280	GS1	Box	5	In Commercial Distribution
Primary	04049089100283	GS1