25-27G BriteLight™ Angled 20° EndoProbe® Single

GUDID 00813125015404

IRIDEX CORPORATION

Ophthalmic laser system beam guide Ophthalmic laser system beam guide

• Primary Device ID: 00813125015404
• NIH Device Record Key: a7d8ee4b-78bb-4d78-8ffe-db28746ea34e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 25-27G BriteLight™ Angled 20° EndoProbe® Single
• Version Model Number: 14560-1
• 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

Customer Support Contacts

• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813125015404 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

Devices Manufactured by IRIDEX CORPORATION

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• 00813125015282 - TxCell for IQ577, Iridex Z 30 & CSO980: 2022-08-09 TxCell Scanning Laser Delivery System for IQ577, Iridex Z 30 & CSO980 (without prism)