Eye Safety Filter, Fixed (810 nm)

GUDID 00813125010195

General/multiple surgical diode laser system

Primary Device ID	00813125010195
NIH Device Record Key	b0937307-8b20-4eff-af4b-2cba51f51ebf
Commercial Distribution Status	In Commercial Distribution
Brand Name	Eye Safety Filter, Fixed (810 nm)
Version Model Number	14080
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	00813125010195 [Primary]

HQF	Laser, Ophthalmic

Steralize Prior To Use	false
Device Is Sterile	false

00813125017125	For use on the Leica or Wild Dovetails OD3 @ 810 nm
00813125017118	For use on the Zeiss Dovetails OD3 @ 810 nm
00813125010195	For use on the Leica M841 Dovetails OD3 @ 810 nm
00813125010188	For use on the Moeller-Wedel Dovetails OD3 @ 810 nm