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

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Primary Device ID00866988000209
NIH Device Record Key642ab44b-230d-482c-824c-16e1eecc41bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltraLase Flexible Laser Waveguide
Version Model NumberHWG500-2.0-3.0
Catalog NumberHWG500-2.0-3.0
Company DUNS028541358
Company NameLASER ENGINEERING
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(508) 520-2500
Emailcustomerinfo@laserengineering.com
Phone(508) 520-2500
Emailcustomerinfo@laserengineering.com
Phone(508) 520-2500
Emailcustomerinfo@laserengineering.com
Phone(508) 520-2500
Emailcustomerinfo@laserengineering.com
Phone(508) 520-2500
Emailcustomerinfo@laserengineering.com
Phone(508) 520-2500
Emailcustomerinfo@laserengineering.com
Phone(508) 520-2500
Emailcustomerinfo@laserengineering.com
Phone(508) 520-2500
Emailcustomerinfo@laserengineering.com
Phone(508) 520-2500
Emailcustomerinfo@laserengineering.com
Phone(508) 520-2500
Emailcustomerinfo@laserengineering.com
Phone(508) 520-2500
Emailcustomerinfo@laserengineering.com
Phone(508) 520-2500
Emailcustomerinfo@laserengineering.com
Phone(508) 520-2500
Emailcustomerinfo@laserengineering.com
Phone(508) 520-2500
Emailcustomerinfo@laserengineering.com
Phone(508) 520-2500
Emailcustomerinfo@laserengineering.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100866988000209 [Primary]
GS110866988000206 [Package]
Package: [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

On-Brand Devices [UltraLase Flexible Laser Waveguide]

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

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