FDA UDI
In Commercial Distribution
🇺🇸 United States
Auto Lensmeter HLM-7000
DI: 08800019600398
·
Model: HLM-7000
·
Huvitz Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Auto Lensmeter HLM-7000
- Primary DI
- 08800019600398
- Version / Model
- HLM-7000
- Catalog Number
- HLM-7000
- Company Name
- Huvitz Co., Ltd.
- Labeler DUNS
- 688154202
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-24
- Public Version
- 1
- Public Version Date
- 2019-06-03
- Public Version Status
- New
- Public Device Record Key
- 26633322-1651-42d4-9145-fcc5b13dbf47
Device Description
Lensmeter is a machine to generate Sph, Cyl and Axis information of lens by measuring refraction of the lens
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 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 | 08800019600398 | GS1 |
Customer Contacts
- Phone
- +82314289100
- [email protected]