Eye Cubed V4 New Gen

GUDID 09342395001370

ELLEX MEDICAL PTY LTD

Ophthalmic ultrasound imaging system

• Primary Device ID: 09342395001370
• NIH Device Record Key: 05fd7cf5-b784-45af-a3d0-bfac718e8c7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eye Cubed V4 New Gen
• Version Model Number: I3 SYSTEM-ABDU
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	09342395001370 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103608

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-10-18
• Device Publish Date: 2016-09-24

Devices Manufactured by ELLEX MEDICAL PTY LTD

• 09342395002278 - 40MHZKIT-USA: 2024-12-04
• 09342395002285 - ACC00042: 2024-12-04
• 09342395001370 - Eye Cubed V4 New Gen: 2024-10-18
• 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