G-Probe™ Illuminate Single

GUDID 00813125015367

IRIDEX CORPORATION

Ophthalmic laser system beam guide

• Primary Device ID: 00813125015367
• NIH Device Record Key: 73c82e91-8923-4d50-b85b-2fd29e6c26c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G-Probe™ Illuminate Single
• Version Model Number: 16000-1
• 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
• Phone: (800)388-4747
• Email: techsupport@iridex.com
• Phone: (800)388-4747
• Email: techsupport@iridex.com
• Phone: (800)388-4747
• Email: techsupport@iridex.com
• Phone: (800)388-4747
• Email: techsupport@iridex.com
• Phone: (800)388-4747
• Email: techsupport@iridex.com
• Phone: (800)388-4747
• Email: techsupport@iridex.com
• Phone: (800)388-4747
• Email: techsupport@iridex.com
• Phone: (800)388-4747
• Email: techsupport@iridex.com
• Phone: (800)388-4747
• Email: techsupport@iridex.com
• Phone: (800)388-4747
• Email: techsupport@iridex.com
• Phone: (800)388-4747
• Email: techsupport@iridex.com
• Phone: (800)388-4747
• Email: techsupport@iridex.com
• Phone: (800)388-4747
• Email: techsupport@iridex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813125015367 [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: 2017-03-24

On-Brand Devices [G-Probe™ Illuminate Single]

• 00813125015701: 16200-1
• 00813125015367: 16000-1