UltraLase Flexible Laser Waveguide HWG505

GUDID 10866988000213

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: 10866988000213
• NIH Device Record Key: 61886dc5-5920-48fe-8995-5b32ccefdd58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraLase Flexible Laser Waveguide
• Version Model Number: HWG505
• Catalog Number: HWG505
• 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: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com
• Phone: 5085202552
• Email: r.rudko@laserengineering.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866988000216 [Primary]
GS1	10866988000213 [Package]; Contains: 00866988000216; Package: [3 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-16
• Device Publish Date: 2021-11-08

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