3nethra
Basic Information
- Brand Name
- 3nethra
- Primary DI
- 08908007754044
- Version / Model
- neo P1000 probe
- Company Name
- FORUS HEALTH PRIVATE LIMITED
- Labeler DUNS
- 864213893
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-06
- Public Version
- 1
- Public Version Date
- 2018-05-07
- Public Version Status
- New
- Public Device Record Key
- 412fafbe-da2b-40b0-8b91-22d666a4ab92
Device Description
The 3nethra neo P1000 is a mydriatic digital imaging camera used for capturing and storing images of the human retina. The device acquires only digital photographs of the eye and does not provide any analysis or diagnosis. The 3nethra neo has a hand-held probe, a control unit, and a foot pedal. Components such as warm white LEDs, lenses, aperture, sensitive photodetector arrays (CMOS sensor array) are housed in the probe. The light emitted is within the safe limits of group 1 radiant exposure specifications for ultraviolet, visible, and infrared radiation under all light energy conditions, as defined in the 15004-2 (and ANSI Z80.36-2016) Light Hazard Protection standards for Ophthalmic Instruments. 3nethra neo includes an application software that facilitates the capture, storage, and retrieval of images. Illumination and focus are adjusted using a foot pedal.
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
- Yes
- 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 |
|---|---|---|---|---|
| PJZ | Camera, Ophthalmic, General-Use | 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08908007754044 | GS1 |