FDA UDI
In Commercial Distribution
🇺🇸 United States
RETIA 2
DI: 08053677040086
·
Model: RETIA 2
·
CENTERVUE SPA
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RETIA 2
- Primary DI
- 08053677040086
- Version / Model
- RETIA 2
- Catalog Number
- AINEUME002
- Company Name
- CENTERVUE SPA
- Labeler DUNS
- 338702316
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-15
- Public Version
- 5
- Public Version Date
- 2021-02-19
- Public Version Status
- Update
- Public Device Record Key
- 5eae1f19-1009-4116-9f74-61b9aa55caa6
Device Description
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.
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 10551 | Ophthalmic fundus camera | An electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera. | No | Active |
| 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 | 08053677040086 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180293 | 000 |