Bausch + Lomb
Rong Lach SAC Belz USD Calahan
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
Record
| Listed by | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | HNG |
| Device type | Rongeur, Lachrymal Sac |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-11-20 |
| Record revised | 2025-04-10 (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 |
|---|---|---|
| E4590 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rongeur | Katena Products, Inc. | 6 |
| Stephens Instruments | Krishna Imports Inc | 5 |
| Rumex | Rumex International Co. | 2 |
| Intacs Pocketing Hook | Addition Technology, Inc. | 1 |
| Belz Lacrimal Sac Rongeur | Bausch & Lomb Incorporated | 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.