UltraQ Reflex Neo

GUDID 09342395002223

ELLEX MEDICAL PTY LTD

Ophthalmic solid-state laser system

• Primary Device ID: 09342395002223
• NIH Device Record Key: 2cdd5111-0f43-4281-91ff-3100401a683d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraQ Reflex Neo
• Version Model Number: UltraQ Reflex Neo
• Company DUNS: 756138509
• Company Name: ELLEX MEDICAL PTY LTD
• 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	09342395002223 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222395

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: 2023-05-09
• Device Publish Date: 2023-05-01

Devices Manufactured by ELLEX MEDICAL PTY LTD

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• 09342395002285 - ACC00042: 2024-12-04
• 09342395001370 - Eye Cubed V4 New Gen: 2024-10-18
• 09342395000038 - UltraQ: 2024-10-17
• 09342395000069 - Solo: 2024-10-17
• 09342395000113 - Tango: 2024-10-17
• 09342395000137 - UltraQ: 2024-10-17
• 09342395000212 - 2RT: 2024-10-17