RETIA 2 AINEUME002

GUDID 08053677040086

The CenterVue Retia 2 Camera is intended for taking digital autofluorescence images of the human retina with and without use of a mydriatic agent to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina.

CENTERVUE SPA

Ophthalmic fundus camera

• Primary Device ID: 08053677040086
• NIH Device Record Key: 5eae1f19-1009-4116-9f74-61b9aa55caa6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RETIA 2
• Version Model Number: RETIA 2
• Catalog Number: AINEUME002
• Company DUNS: 338702316
• Company Name: CENTERVUE SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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	08053677040086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180293

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: 5
• Public Version Date: 2021-02-19
• Device Publish Date: 2017-07-15

Devices Manufactured by CENTERVUE SPA

• 08053677040031 - EIDON: 2021-02-19 EIDON is a scanning ophthalmoscope which uses infrared and visible light to obtain confocal images of the retina, without pharma
• 08053677040062 - EIDON: 2021-02-19 RETIA is a scanning ophthalmoscope which uses infrared and blue light to obtain confocal infrared reflectance images and fluores
• 08053677040079 - EIDON: 2021-02-19 EIDON AF (Eidon from Greek eidou, “to see” and AF, AutoFluorescence) is a scanning ophthalmoscope which uses infrared and vi
• 08053677040086 - RETIA 2: 2021-02-19The CenterVue Retia 2 Camera is intended for taking digital autofluorescence images of the human retina with and without use of a mydriatic agent to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina.
• 08053677040086 - RETIA 2: 2021-02-19 The CenterVue Retia 2 Camera is intended for taking digital autofluorescence images of the human retina with and without use of
• 08053677040093 - EIDON: 2021-02-19 The CenterVue EIDON FA is a confocal scanning ophthalmoscope indicated for color, infrared and auto-fluorescence imaging and flu
• 08053677040116 - DRSplus: 2019-12-17 The CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color imaging of a human retina without the use of a m