Eye Safety Filter, Fixed (577 nm)

GUDID 00813125017163

For use on the Leica/Wild Dovetails OD3 @ 577 nm

IRIDEX CORPORATION

General/multiple surgical diode laser system
Primary Device ID00813125017163
NIH Device Record Keye8836fc8-9ef7-4305-bacf-6aeaba96a350
Commercial Distribution StatusIn Commercial Distribution
Brand NameEye Safety Filter, Fixed (577 nm)
Version Model Number65470
Company DUNS612920785
Company NameIRIDEX CORPORATION
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813125017163 [Primary]

FDA Product Code

HQFLaser, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-30
Device Publish Date2024-10-22

On-Brand Devices [Eye Safety Filter, Fixed (577 nm)]

00813125017170For use on the Zeiss Dovetails OD3 @ 577 nm
00813125017163For use on the Leica/Wild Dovetails OD3 @ 577 nm
00813125015039For use on the Leica Dovetails OD3 @ 577 nm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.