Eye Safety Filter, Fixed (577 nm)

GUDID 00813125017170

For use on the Zeiss Dovetails OD3 @ 577 nm

IRIDEX CORPORATION

General/multiple surgical diode laser system

• Primary Device ID: 00813125017170
• NIH Device Record Key: af10367e-8aad-49a6-8b5d-4a497078a9bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eye Safety Filter, Fixed (577 nm)
• Version Model Number: 65471
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00813125017170 [Primary]

FDA Product Code

• HQF: Laser, Ophthalmic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-30
• Device Publish Date: 2024-10-22

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

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