Imperium CO2-300

GUDID 00866988000247

CO2 Laser Waveguide - 300 microns

LASER ENGINEERING

Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 00866988000247
• NIH Device Record Key: 6325747f-7f33-4acd-9df1-892c1f0446bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Imperium
• Version Model Number: CO2-300
• Catalog Number: CO2-300
• 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	00866988000247 [Primary]
GS1	10866988000244 [Package]; 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