UltraLase Flexible Laser Waveguide HWG500-2.0-3.0

GUDID 00866988000209

This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to the patient

LASER ENGINEERING

Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 00866988000209
• NIH Device Record Key: 642ab44b-230d-482c-824c-16e1eecc41bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraLase Flexible Laser Waveguide
• Version Model Number: HWG500-2.0-3.0
• Catalog Number: HWG500-2.0-3.0
• Company DUNS: 028541358
• Company Name: LASER ENGINEERING
• 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

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	00866988000209 [Primary]
GS1	10866988000206 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [UltraLase Flexible Laser Waveguide]

• 00866988000223: This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to t
• 00866988000209: This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to t
• 10866988000268: This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to t
• 10866988000213: This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to t