EIDON AINEUME001

GUDID 08053677040062

RETIA is a scanning ophthalmoscope which uses infrared and blue light to obtain confocal infrared reflectance images and fluorescence images of the retina.

CENTERVUE SPA

Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system

• Primary Device ID: 08053677040062
• NIH Device Record Key: 4ba88922-952c-4db3-8743-655fe4d33fbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EIDON
• Version Model Number: RETIA
• Catalog Number: AINEUME001
• 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	08053677040062 [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: 2016-08-03

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