FDA UDI
In Commercial Distribution
🇺🇸 United States
EIDON
DI: 08053677040062
·
Model: RETIA
·
CENTERVUE SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EIDON
- Primary DI
- 08053677040062
- Version / Model
- RETIA
- Catalog Number
- AINEUME001
- Company Name
- CENTERVUE SPA
- Labeler DUNS
- 338702316
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-03
- Public Version
- 4
- Public Version Date
- 2021-02-19
- Public Version Status
- Update
- Public Device Record Key
- 4ba88922-952c-4db3-8743-655fe4d33fbd
Device Description
RETIA is a scanning ophthalmoscope which uses infrared and blue light to obtain confocal infrared reflectance images and fluorescence images of the retina.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MYC | Ophthalmoscope,Laser,Scanning | Ophthalmic | 886.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47952 | Scanning-laser ophthalmic imaging system | An assembly of electrically-powered ophthalmic instruments and digital image capturing/processing devices that uses a low power laser beam to scan in two dimensions over the retina and detect the reflected (or returned) light to generate and capture digital confocal images of the fundus. It typically consists of a laser, optics, image detection system, a digital processor/computer, application software and image display monitor(s). It is typically used for, e.g., assessment/control of diabetic retinopathy/maculopathy, age-related macular degeneration (AMD), choroidal neovascularization (CNV), detection of retinal vascular disturbances, and diagnosis of chorioditis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08053677040062 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142047 | 000 |