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 Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera
Primary Device ID08053677040086
NIH Device Record Key5eae1f19-1009-4116-9f74-61b9aa55caa6
Commercial Distribution StatusIn Commercial Distribution
Brand NameRETIA 2
Version Model NumberRETIA 2
Catalog NumberAINEUME002
Company DUNS338702316
Company NameCENTERVUE SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108053677040086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MYCOphthalmoscope, Laser, Scanning

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-02-19
Device Publish Date2017-07-15

Devices Manufactured by CENTERVUE SPA

08053677040031 - EIDON2021-02-19 EIDON is a scanning ophthalmoscope which uses infrared and visible light to obtain confocal images of the retina, without pharma
08053677040062 - EIDON2021-02-19 RETIA is a scanning ophthalmoscope which uses infrared and blue light to obtain confocal infrared reflectance images and fluores
08053677040079 - EIDON2021-02-19 EIDON AF (Eidon from Greek eidou, “to see” and AF, AutoFluorescence) is a scanning ophthalmoscope which uses infrared and vi
08053677040086 - RETIA 22021-02-19The 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 22021-02-19 The CenterVue Retia 2 Camera is intended for taking digital autofluorescence images of the human retina with and without use of
08053677040093 - EIDON2021-02-19 The CenterVue EIDON FA is a confocal scanning ophthalmoscope indicated for color, infrared and auto-fluorescence imaging and flu
08053677040116 - DRSplus2019-12-17 The CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color imaging of a human retina without the use of a m

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