20G Fluted EndoProbe® Single

GUDID 00851089000357

Fiberoptic laser delivery device

IRIDEX CORPORATION

Ophthalmic laser system beam guide

• Primary Device ID: 00851089000357
• NIH Device Record Key: b775a5e7-b801-475c-9e2b-f7886a6ca3ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 20G Fluted EndoProbe® Single
• Version Model Number: 11473-1
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00851089000357 [Primary]

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-06
• Device Publish Date: 2019-10-29

Devices Manufactured by IRIDEX CORPORATION

• 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