EIDON AIFLUME001

GUDID 08053677040079

EIDON AF (Eidon from Greek eidou, “to see” and AF, AutoFluorescence) is a scanning ophthalmoscope which uses infrared and visible light to obtain confocal infrared reflectance images, confocal visible reflectance images of the retina and fluorescence images of the retina, without pharmacological dilation. EIDON is a standalone device.

CENTERVUE SPA

Scanning-laser ophthalmic imaging system

• Primary Device ID: 08053677040079
• NIH Device Record Key: b241e6b3-98a3-49cc-b00c-31360e8bca43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EIDON
• Version Model Number: EIDON AF
• Catalog Number: AIFLUME001
• Company DUNS: 338702316
• Company Name: CENTERVUE SPA
• 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: true
• Serial Number: true
• Manufacturing Date: false
• 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	08053677040079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142047

FDA Product Code

• MYC: Ophthalmoscope,Laser,Scanning

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: 2021-02-19
• Device Publish Date: 2016-07-29

On-Brand Devices [EIDON]

• 08053677040093: The CenterVue EIDON FA is a confocal scanning ophthalmoscope indicated for color, infrared and a
• 08053677040079: EIDON AF (Eidon from Greek eidou, “to see” and AF, AutoFluorescence) is a scanning ophthalmo
• 08053677040062: RETIA is a scanning ophthalmoscope which uses infrared and blue light to obtain confocal infrare
• 08053677040031: EIDON is a scanning ophthalmoscope which uses infrared and visible light to obtain confocal imag