Endovascular Laser Vein System (ELVeS®) Kit 101235

GUDID 04049089200280

Ceram Optec SIA

Varicose vein lasing procedure kit

• Primary Device ID: 04049089200280
• NIH Device Record Key: 31275c58-b930-43de-be81-8cf3f4d58860
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endovascular Laser Vein System (ELVeS®) Kit
• Version Model Number: ELVeS® Radial® Kit 6Fx7cm
• Catalog Number: 101235
• Company DUNS: 506069240
• Company Name: Ceram Optec SIA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049089100283 [Primary]
GS1	04049089200280 [Package]; Contains: 04049089100283; Package: Box [5 Units]; In Commercial Distribution

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-01-31

On-Brand Devices [Endovascular Laser Vein System (ELVeS®) Kit]

• 04049089200297: ELVeS® Radial® Slim Kit 4Fx11cm
• 04049089200280: ELVeS® Radial® Kit 6Fx7cm
• 04049089200273: ELVeS® Radial® Slim Kit 4Fx7cm
• 04049089200266: ELVeS® Radial® Kit 6Fx11cm