Bausch + Lomb
Osher HD Magnifier
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
Record
| Listed by | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | HRB |
| Device type | Microscope, Operating, Non-Electric, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4700 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-08-08 |
| Record revised | 2025-09-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E7003 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Firefly | Firefly Global | 2 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.