UltraLase Flexible Laser Waveguide HWG300-OTO

GUDID 10866988000268

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: 10866988000268
• NIH Device Record Key: 3ff42e5d-8f08-4d03-b694-d4197b152da0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraLase Flexible Laser Waveguide
• Version Model Number: HWG300-OTO
• Catalog Number: HWG300-OTO
• 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
• Phone: (508)520-2500
• Email: customerinfo@laserengineering.com
• Phone: (508)520-2500
• Email: customerinfo@laserengineering.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866988000261 [Primary]
GS1	10866988000268 [Package]; Contains: 00866988000261; 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: 2020-03-31
• Device Publish Date: 2020-03-23

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