FDA UDI
In Commercial Distribution
🇺🇸 United States
LensChekPro
DI: 00812559012287
·
Model: 15185
·
REICHERT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LensChekPro
- Primary DI
- 00812559012287
- Version / Model
- 15185
- Company Name
- REICHERT, INC.
- Labeler DUNS
- 126650253
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-12
- Public Version
- 1
- Public Version Date
- 2025-08-20
- Public Version Status
- New
- Public Device Record Key
- 94a02da9-2e5c-43e2-a56e-8d9d09e0f032
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
- 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 |
|---|---|---|---|---|
| 45753 | Automated lensmeter | 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. The device is fully automated and does not require manual adjustments of its measurement systems. It provides the operator with automatic readings on an integral screen, and will typically record and print-out the results. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812559012287 | GS1 |