FDA UDI
In Commercial Distribution
🇺🇸 United States
Amico Diagnostic Ophthalmoscope
DI: 00697077001063
·
Model: DH-W35-CL-L
·
Amico Diagnostic Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Amico Diagnostic Ophthalmoscope
- Primary DI
- 00697077001063
- Version / Model
- DH-W35-CL-L
- Company Name
- Amico Diagnostic Incorporated
- Labeler DUNS
- 203163290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2024-11-27
- Public Version Status
- Update
- Public Device Record Key
- c3ee0c6b-fbd7-4dc9-acc5-73c5c12e042a
Device Description
Coaxial Ophthalmoscope Locking Instrument Head, 3.5V LED
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
- No
- 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 |
|---|---|---|---|---|
| HLI | Ophthalmoscope, Ac-Powered | Ophthalmic | 886.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46786 | Direct ophthalmoscope | An electrically-powered, hand-held, ophthalmic instrument designed to be held close to the patient’s eye to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, and vitreous] by producing an upright (unreversed) image of approximately 15 times magnification. It consists of a main unit (commonly referred to as the head) with a built-in light source directed through the pupil to illuminate the interior of the eyeball, a mirror with a single hole for viewing, and a dial containing lenses of different powers; a dedicated power supply handpiece may be included with the head. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00697077001063 | GS1 |
Customer Contacts
- Phone
- 1-877-264-2697
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131939 | 000 |