FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Verily Numetric Retinal Camera
DI: 00860000249584
·
Model: VNRC -101
·
VERILY LIFE SCIENCES LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Verily Numetric Retinal Camera
- Primary DI
- 00860000249584
- Version / Model
- VNRC -101
- Company Name
- VERILY LIFE SCIENCES LLC
- Labeler DUNS
- 080061720
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-24
- Public Version
- 2
- Public Version Date
- 2026-04-28
- Public Version Status
- Update
- Public Device Record Key
- e4f52c8a-d05d-4258-b2b8-e244128ff933
- Distribution End Date
- 2026-04-27
Device Description
Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina segment of the eye to be evaluated under non-mydriatic conditions. Verily Numetric Retinal Camera is indicated for in-vivo viewing of the posterior segment of the eye. The images are intended for use as an aid to clinicians in the evaluation, diagnosis, and documentation of ocular health.
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
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- 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 | 00860000249584 | GS1 |
Customer Contacts
- Phone
- 855-629-0918
- [email protected]