Eye Safety Filter, Fixed (532 nm)

GUDID 00813125017132

For use on the Topcon Dovetails OD3 @ 532 nm

IRIDEX CORPORATION

General/multiple surgical diode laser system

• Primary Device ID: 00813125017132
• NIH Device Record Key: 4d770381-36ef-4fe9-9fca-f643d1e26c8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eye Safety Filter, Fixed (532 nm)
• Version Model Number: 30366
• 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	00813125017132 [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: 2024-10-29
• Device Publish Date: 2024-10-21

On-Brand Devices [Eye Safety Filter, Fixed (532 nm) ]

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