Home GUDID 00866988000292 Laser Engineering
Primary DI 00866988000292
Brand Laser Engineering
Company LASER ENGINEERING
Model HWG305-OTO
Catalog number HWG305-OTO
Device description This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to the patient.
Published 2024-08-20
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name GEX Powered Laser Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEX Powered Laser Surgical Instrument General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10866988000299 Package GS1 3 In Commercial Distribution 00866988000292 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10866988000299 10866988000299 00866988000292 00866988000292 866988000292 0866988000292
GMDN Terms# Term, Definition table Term Definition Urogenital surgical laser system beam guide, single-use A flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications, typically to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), and/or to treat bladder, urethral, ureteral conditions (e.g., tumours, condylomas) or gynaecological disorders; it is not intended for other surgical applications. It is typically made of fibreoptic materials or fused silica and contains an invasive laser-firing distal end which may be available in a variety of configurations. This is a single-use device.
Regulatory Flags# DUNS number 028541358 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00866988000285 Laser Engineering HWG305 HWG305 2024-08-20 10866988000299 Laser Engineering HWG305-OTO HWG305-OTO 2024-08-20 00860011139706 Laser Engineering OTO Handpiece 1059746 2024-04-11 00866988000216 UltraLase Flexible Laser Waveguide HWG505 HWG505 2021-11-08 10866988000213 UltraLase Flexible Laser Waveguide HWG505 HWG505 2021-11-08 00866988000230 Imperium CO2-500 CO2-500 2018-12-31 00866988000261 UltraLase Flexible Laser Waveguide HWG300-OTO HWG300-OTO 2020-03-23 00866988000209 UltraLase Flexible Laser Waveguide HWG500-2.0-3.0 HWG500-2.0-3.0 2016-09-20 00866988000223 UltraLase Flexible Laser Waveguide HWG300-2.0-3.0 HWG300-2.0-3.0 2016-09-20 00866988000247 Imperium CO2-300 CO2-300 2018-12-31 10866988000268 UltraLase Flexible Laser Waveguide HWG300-OTO HWG300-OTO 2020-03-23 10866988000237 Imperium CO2-500 CO2-500 2018-12-31
Other Devices Sharing Product Codes# 
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