FDA UDI
In Commercial Distribution
🇺🇸 United States
3nethra
DI: 08908007754068
·
Model: neo probe
·
FORUS HEALTH PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 3nethra
- Primary DI
- 08908007754068
- Version / Model
- neo 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
- 2019-01-21
- Public Version
- 1
- Public Version Date
- 2019-02-21
- Public Version Status
- New
- Public Device Record Key
- a9b50551-e26c-479e-83d2-07a4acc55af0
Device Description
3nethra neo is a contact device to capture digital color images of the retina of infants having less than 55 weeks of Post Menstrual Age (PMA), while their eyes are dilated using mydriatic drops under clinical control.
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
- 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 |
|---|---|---|---|---|
| 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08908007754068 | GS1 |
Customer Contacts
- Phone
- 1-510-4886805
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183059 | 000 |