FDA UDI
In Commercial Distribution
🇺🇸 United States
Optomed Aurora retinal set
DI: 06430046260795
·
Model: 60101078A
·
Optomed Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Optomed Aurora retinal set
- Primary DI
- 06430046260795
- Version / Model
- 60101078A
- Company Name
- Optomed Oy
- Labeler DUNS
- 401968495
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-04
- Public Version
- 2
- Public Version Date
- 2021-11-23
- Public Version Status
- Update
- Public Device Record Key
- 600046b6-e718-42c1-b94b-381e3cf76e90
Device Description
Optomed Aurora retinal set including Aurora camera and Aurora retinal module.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | Ophthalmic | 886.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58857 | Multi-purpose digital medical camera | An electrically-powered, hand-held digital electro-optical device designed to capture video or still image data for multiple medical applications (e.g., ophthalmoscopic, otoscopic, and dermatoscopic) using dedicated interchangeable lenses/attachments. It typically consists of a lightproof chamber with an aperture fitted with a lens and a shutter, through which the image of an object is projected onto a surface for recording. It may include a user display screen for visualization before image capture, and sometimes a docking cradle for battery recharging and connection to a personal computer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06430046260795 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180378 | 000 |