FDA UDI
In Commercial Distribution
🇺🇸 United States
Optomed Smartscope FA
DI: 06430046261006
·
Model: 41000040
·
Optomed Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Optomed Smartscope FA
- Primary DI
- 06430046261006
- Version / Model
- 41000040
- Company Name
- Optomed Oy
- Labeler DUNS
- 401968495
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-12
- Public Version
- 1
- Public Version Date
- 2025-12-22
- Public Version Status
- New
- Public Device Record Key
- 4bde4aab-b944-47fd-818b-ca8c4807ae73
Device Description
Optomed Smartscope FA optic module
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
- 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 |
|---|---|---|---|---|
| 60843 | Multi-purpose digital medical camera lens, intraocular, fluorescent angiography | A non-sterile optical device intended for attachment to a multi-purpose digital medical camera to provide high-resolution focusing of digital imaging data from the fundus of the eye in fluoroscopic studies. It is intended for capturing images as a fluorescent dye (e.g., fluorescein sodium) injected into a peripheral vein circulates in the retina. The lens utilizes a specific wavelength of light to capture fluorescent images which can demonstrate abnormalities within the neurosensory retina, pigment epithelium, sclera, choroid, and optic nerve. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06430046261006 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201325 | 000 |