Imperium CO2-500

GUDID 10866988000237

CO2 Laser Waveguide - 500 microns

LASER ENGINEERING

Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 10866988000237
• NIH Device Record Key: f263bcb0-1d25-4a41-9d4e-ec049fddd19a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Imperium
• Version Model Number: CO2-500
• Catalog Number: CO2-500
• Company DUNS: 028541358
• Company Name: LASER ENGINEERING
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Customer Support Contacts

• Phone: (508) 520-2500
• Email: customerinfo@laserengineering.com
• Phone: (508) 520-2500
• Email: customerinfo@laserengineering.com
• Phone: (508) 520-2500
• Email: customerinfo@laserengineering.com
• Phone: (508) 520-2500
• Email: customerinfo@laserengineering.com
• Phone: (508) 520-2500
• Email: customerinfo@laserengineering.com
• Phone: (508) 520-2500
• Email: customerinfo@laserengineering.com
• Phone: (508) 520-2500
• Email: customerinfo@laserengineering.com
• Phone: (508) 520-2500
• Email: customerinfo@laserengineering.com
• Phone: (508) 520-2500
• Email: customerinfo@laserengineering.com
• Phone: (508) 520-2500
• Email: customerinfo@laserengineering.com
• Phone: (508) 520-2500
• Email: customerinfo@laserengineering.com
• Phone: (508) 520-2500
• Email: customerinfo@laserengineering.com
• Phone: (508) 520-2500
• Email: customerinfo@laserengineering.com
• Phone: (508) 520-2500
• Email: customerinfo@laserengineering.com
• Phone: (508) 520-2500
• Email: customerinfo@laserengineering.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866988000230 [Primary]
GS1	10866988000237 [Package]; Contains: 00866988000230; Package: [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112166

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-31
• Device Publish Date: 2018-12-31

On-Brand Devices [Imperium]

• 00866988000247: CO2 Laser Waveguide - 300 microns
• 10866988000237: CO2 Laser Waveguide - 500 microns