Eye Safety Filter, Fixed (532 nm)

GUDID 00813125017149

For use on the Zeiss Dovetails OD3 @ 532 nm

IRIDEX CORPORATION

General/multiple surgical diode laser system
Primary Device ID00813125017149
NIH Device Record Keyeebefe52-bafb-4155-8ea8-a2ddd6e84f0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEye Safety Filter, Fixed (532 nm)
Version Model Number30367
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
GS100813125017149 [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 (532 nm) ]

00813125017156For use on the Leica or Wild Dovetails OD3 @ 532 nm
00813125017132For use on the Topcon Dovetails OD3 @ 532 nm
00813125017149For use on the Zeiss Dovetails OD3 @ 532 nm
00813125010256For use on the Leica M841 Dovetails OD3 @ 532 nm
00813125010249For use on the Moeller-Wedel Dovetails OD3 @ 532 nm

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