ESSILOR RET1IN

GUDID 03664188000435

Automatic eye-fundus camera and software intended for photographing, displaying,and storing images of the retina without the use of a mydriatic agent.

LUNEAU TECHNOLOGY OPERATIONS

Ophthalmic fundus camera

• Primary Device ID: 03664188000435
• NIH Device Record Key: 4354ac9c-5d8b-4390-91f7-a90c7da56f77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESSILOR
• Version Model Number: Retina 800
• Catalog Number: RET1IN
• Company DUNS: 260432380
• Company Name: LUNEAU TECHNOLOGY OPERATIONS
• 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	03664188000435 [Primary]

FDA Product Code

• HKI: Camera, Ophthalmic, Ac-Powered

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: 2025-01-10
• Device Publish Date: 2025-01-02

On-Brand Devices [ESSILOR]

• 03664188000565: WAM800 is a multifunctional eye diagnostic device.
• 03664188000558: WAM700+ is a multifunctional eye diagnostic device.
• 03664188000435: Automatic eye-fundus camera and software intended for photographing, displaying,and storing imag