IRIDEX 810 Laser

GUDID 00813125016654

General/multiple surgical diode laser system

Primary Device ID	00813125016654
NIH Device Record Key	06b07f17-b7ef-4b22-8970-40611e287ddd
Commercial Distribution Status	In Commercial Distribution
Brand Name	IRIDEX 810 Laser
Version Model Number	22000
Company DUNS	612920785
Company Name	IRIDEX CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00813125016654 [Primary]

GEX	Powered Laser Surgical Instrument

Steralize Prior To Use	false
Device Is Sterile	false

00813125010249 - Eye Safety Filter, Fixed (532 nm)	2024-10-30 For use on the Moeller-Wedel Dovetails OD3 @ 532 nm
00813125010256 - Eye Safety Filter, Fixed (532 nm)	2024-10-30 For use on the Leica M841 Dovetails OD3 @ 532 nm
00813125010263 - Eye Safety Filter, Two-Position (532 nm)	2024-10-30 For use on the Leica or Wild Dovetails OD3 @ 532 nm
00813125010270 - Eye Safety Filter, Two-Position (532 nm)	2024-10-30 For use on the Zeiss Dovetails OD3 @ 532 nm
00813125014490 - Eye Safety Filter, Two-Position (577 nm)	2024-10-30 For use on the Leica or Wild Dovetails OD3 @ 577 nm
00813125014506 - Eye Safety Filter, Two-Position (577 nm)	2024-10-30 For use on the Zeiss Dovetails OD3 @ 577 nm
00813125014513 - Eye Safety Filter, Two-Position (532 nm)	2024-10-30 For use on the Leica or Wild Dovetails OD3 @ 532 nm
00813125014520 - Eye Safety Filter, Two-Position (532 nm)	2024-10-30 For use on the Zeiss Dovetails OD3 @ 532 nm