FDA UDI
Not in Commercial Distribution
🇺🇸 United States
RHA
DI: 00627843652021
·
Model: RHA2020/2020-U
·
Annidis Health Systems Corp
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RHA
- Primary DI
- 00627843652021
- Version / Model
- RHA2020/2020-U
- Company Name
- Annidis Health Systems Corp
- Labeler DUNS
- 243651440
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-05
- Public Version
- 4
- Public Version Date
- 2021-08-05
- Public Version Status
- Update
- Public Device Record Key
- 27e6a7c9-f70d-4462-ac44-af63b1c40370
- Distribution End Date
- 2021-08-05
Device Description
The Annidis RHA2020-U multi-spectral digital ophthalmoscope is intended to capture images of the fundus of the eye which can be used to assist in diagnosis and observation of fundus diseases.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | Ophthalmic | 886.1120 | 2 |
| HLI | Ophthalmoscope, Ac-Powered | Ophthalmic | 886.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46787 | Direct ophthalmoscope, line-powered | A mains electricity (AC-powered), hand-held, ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see the details of the retina and other structures/media (cornea, aqueous, lens, and vitreous). It consists of, a built-in light that is directed by the examiner through the pupil to illuminate the interior of the eyeball, a mirror with a single hole through which the examiner will view, and a dial containing several lenses of different powers that can be alternated by the examiner whilst viewing. It produces an upright, or unreversed, image of approximately 15 times magnification. The power is run through a transformer to reduce this to low-voltage. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00627843652021 | GS1 |
Customer Contacts
- Phone
- 613 596 1800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111531 | 000 |