FDA UDI
In Commercial Distribution
🇺🇸 United States
RODENSTOCK
DI: 03664188000404
·
Model: DNEye Scanner 3
·
LUNEAU TECHNOLOGY OPERATIONS
Product Codes
3
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RODENSTOCK
- Primary DI
- 03664188000404
- Version / Model
- DNEye Scanner 3
- Company Name
- LUNEAU TECHNOLOGY OPERATIONS
- Labeler DUNS
- 260432380
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-08
- Public Version
- 4
- Public Version Date
- 2025-01-15
- Public Version Status
- Update
- Public Device Record Key
- 861dbb98-6307-4da4-b152-fc72100f71ce
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
- 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 |
|---|---|---|---|---|
| HKX | Tonometer, Ac-Powered | Ophthalmic | 886.1930 | 2 |
| MXK | Device, Analysis, Anterior Segment | Ophthalmic | 886.1850 | 2 |
| HKI | Camera, Ophthalmic, Ac-Powered | Ophthalmic | 886.1120 | 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 |
| 65176 | Multiple ocular dimension meter | An electrically-powered, ophthalmic device intended to measure multiple dimensional parameters of the eye (e.g., refractive error, corneal anterior surface curvature/thickness, distance between pupils) during an ophthalmic examination, typically to determine a patient's prescription for glasses or evaluate the need for surgery; it not dedicated to measurement of a single dimensional parameter (i.e., it is not a refractometry-, keratometry-, pachymetry-, pupillometry-, or topography-only device). It may be a hand-held or tabletop device, and may be designed for connection to an off-the-shelf computer for device control and/or results analysis/display. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03664188000404 | GS1 |