Radial-Emitting Shaped Fiber Optic Delivery System 101025

GUDID 04049089100245

Ceram Optec SIA

General/multiple surgical laser system beam guide, single-use, sterile

• Primary Device ID: 04049089100245
• NIH Device Record Key: cf9cf653-b9dd-4a25-a23a-b1a1132fe173
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radial-Emitting Shaped Fiber Optic Delivery System
• Version Model Number: ELVeS® Radial® Fiber 600um, 6F, ID (1x2h)
• Catalog Number: 101025
• 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: false
• 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	04049089100245 [Primary]

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: 3
• Public Version Date: 2018-06-26
• Device Publish Date: 2017-03-07

On-Brand Devices [Radial-Emitting Shaped Fiber Optic Delivery System]

• 04049089100252: ELVeS® Radial® Slim Fiber 400um, 4F, ID (1x2h)
• 04049089100245: ELVeS® Radial® Fiber 600um, 6F, ID (1x2h)