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

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Primary Device ID10866988000268
NIH Device Record Key3ff42e5d-8f08-4d03-b694-d4197b152da0
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltraLase Flexible Laser Waveguide
Version Model NumberHWG300-OTO
Catalog NumberHWG300-OTO
Company DUNS028541358
Company NameLASER ENGINEERING
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
Phone(508)520-2500
Emailcustomerinfo@laserengineering.com
Phone(508)520-2500
Emailcustomerinfo@laserengineering.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100866988000261 [Primary]
GS110866988000268 [Package]
Contains: 00866988000261
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-31
Device Publish Date2020-03-23

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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