G-Probe™ Single

GUDID 00851089000234

IRIDEX CORPORATION

Ophthalmic laser system beam guide

• Primary Device ID: 00851089000234
• NIH Device Record Key: f116a393-d50d-4dae-9d4f-a53f2776fc1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G-Probe™ Single
• Version Model Number: 11256-1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851089000234 [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

• 00813125016920 - LIO Plus (810 nm): 2024-04-04
• 00813125016937 - LIO Plus Large Spot (810 nm): 2024-04-04
• 00813125016944 - LIO Plus (532 nm): 2024-04-04
• 00813125016951 - LIO Plus (532 nm & 810 nm): 2024-04-04
• 00813125016968 - LIO Plus (577 nm): 2024-04-04
• 00813125015381 - Iridex 577 Laser: 2024-01-26 The Iridex® 577 (577 nm, true-yellow) Laser Console is a solid-state laser that is used to deliver laser energy in Continuous-W
• 00813125015473 - Iridex 532 Laser: 2024-01-26 The Iridex® 532 (532, green) Laser Console is a solid-state laser that is used to deliver laser energy in Continuous-Wave for e
• 00813125015282 - TxCell for IQ577, Iridex Z 30 & CSO980: 2022-08-09 TxCell Scanning Laser Delivery System for IQ577, Iridex Z 30 & CSO980 (without prism)