Tango Reflex Neo

GUDID 09342395002209

ELLEX MEDICAL PTY LTD

Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system Ophthalmic solid-state laser system

• Primary Device ID: 09342395002209
• NIH Device Record Key: ba8ad48a-6d51-4d5c-a82e-ab5c459889a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tango Reflex Neo
• Version Model Number: Tango 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	09342395002209 [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

• 09342395000274 - Ellex: 2023-06-19 FGOODS, EYEONE
• 09342395000373 - Ellex: 2023-06-19 FGOODS, EYE PRIME
• 09342395000502 - Ellex: 2023-06-19 FGOODS, WHEELCHAIR ACCESSIBLE, STAND
• 09342395000519 - Ellex: 2023-06-19 FGOODS, WHEELCHAIR ACCESSIBLE, MOBILE
• 09342395000526 - Ellex: 2023-06-19 FGOODS, MOBILE, STAND
• 09342395000540 - Ellex: 2023-06-19
• 09342395000557 - Ellex: 2023-06-19
• 09342395002209 - Tango Reflex Neo: 2023-05-09
• 09342395002209 - Tango Reflex Neo: 2023-05-09