FDA UDI
In Commercial Distribution
🇺🇸 United States
AUTO LENSMETER
DI: 06971821408020
·
Model: TL-6800
·
Ningbo Ming Sing Optical R & D Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AUTO LENSMETER
- Primary DI
- 06971821408020
- Version / Model
- TL-6800
- Company Name
- Ningbo Ming Sing Optical R & D Co., Ltd.
- Labeler DUNS
- 654386890
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-02
- Public Version
- 1
- Public Version Date
- 2019-12-10
- Public Version Status
- New
- Public Device Record Key
- 16348550-73ae-480e-9cf9-46f2be3bdd2c
Device Description
TL-6800 Auto lensmeter Hartmann sensor with 145 measurement points, ensures better result for progressive and multi-focus recognition and more accurate results Green spectral measurement light source Higher level hardware, good tracing performance of the optical system and faster measurement speed Can measure lens of low transmittance rate no less than 5% , sun glasses with dark color, tinted lens and polarized lens UV measurement Humanized design, tiltable screen, comfortable operation and easier for observation Data can be transferred to auto phoropter
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
- Yes
- Has Serial Number
- Yes
- 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 | 06971821408020 | GS1 |
Customer Contacts
- Phone
- +86057487305541
- [email protected]