40MHZKIT-USA

GUDID 09342395002278

ELLEX MEDICAL PTY LTD

Ophthalmic ultrasound imaging system

• Primary Device ID: 09342395002278
• NIH Device Record Key: d0b34267-9505-4d5b-907e-30044e8341cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 40MHZKIT-USA
• Version Model Number: 40MHZ ACCESSORY KIT-USA
• 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: false
• 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	09342395002278 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-04
• Device Publish Date: 2024-11-26

Devices Manufactured by ELLEX MEDICAL PTY LTD

• 09342395002278 - 40MHZKIT-USA: 2024-12-04
• 09342395002278 - 40MHZKIT-USA: 2024-12-04
• 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