Bausch + Lomb
Headmirror Replace 1/2X3 1/2IN
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jiangxi.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangxi Phenix Optical Technology Co., Ltd. | Shangrao | Jiangxi | Manufacturer | 1 |
Record
| Listed by | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | HKF |
| Device type | Mirror, Headband, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1500 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-08-04 |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S2607 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar | Sklar Corporation | 3 |
| BR Surgical, LLC | BR Surgical LLC | 2 |
| Jedmed | Jedmed Instrument Company | 2 |
| clar N 55, LED 6 V, incl. lithium batteries | Rudolf Riester Gmbh | 1 |
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.