FDA UDI
In Commercial Distribution
🇺🇸 United States
Focimeter
DI: 06971922130103
·
Model: CCQ-500
·
Chongqing Yeasn Science & Technology Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Focimeter
- Primary DI
- 06971922130103
- Version / Model
- CCQ-500
- Company Name
- Chongqing Yeasn Science & Technology Co.,Ltd.
- Labeler DUNS
- 547954649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-03
- Public Version
- 1
- Public Version Date
- 2021-03-11
- Public Version Status
- New
- Public Device Record Key
- 4844ecac-9aba-4a9e-ba3f-cd7d76c13fc6
Device Description
mainly measures spherical power, cylindrical power and axis of the cylindrical lens as well as contact lens. It marks on the uncut lens and checks if the spectacle lens is correctly mounted.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| HLM | Instrument, Measuring, Lens, Ac-Powered | Ophthalmic | 886.1425 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12326 | Manually-adjusted lensmeter, line-powered | A mains electricity (AC-powered) ophthalmic instrument designed to measure the focusing power (dioptric power) and other optical characteristics of a spectacle lens, contact lens, or prism through manual adjustments to the instrument performed by the operator. Alternating current provides power for illumination [e.g., with a light-emitting diode (LED)] to make the measurements which are read directly through the optics. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06971922130103 | GS1 |