Bausch + Lomb
Depressor Pick Urrets_zavalia
3manufacturers in China registered for this device type
10catalogue numbers in this listing
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
Record
| Listed by | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | HNX |
| Device type | Depressor, Orbital |
| 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 | 2025-08-08 |
| Record revised | 2025-09-12 (version 3) |
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 |
|---|---|---|
| E6004 | In distribution | |
| E2506 | In distribution | |
| E9105 | In distribution | |
| E9104 | In distribution | |
| E5106 | In distribution | |
| E5105 | In distribution | |
| E5100 10 | In distribution | |
| E5108 | In distribution | |
| E5107 | In distribution | |
| E5112 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Scleral Depressors | Aurora Surgical, LLC | 13 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 8 |
| ONE | Moria, Inc. | 8 |
| Depressor, Orbital | DePuy Mitek, Inc. | 8 |
| Ambler Surgical | Ambler Surgical, LLC | 7 |
| Stephens Instruments | Krishna Imports Inc | 6 |
| Millennium | Avalign Technologies, Inc. | 6 |
| Duckworth & Kent | Duckworth AND Kent Limited | 5 |
| Orbit Depressor | Katena Products, Inc. | 5 |
| HNM Medical | HNM Stainless, LLC. | 5 |
| V. Mueller | Steris Corporation | 5 |
| Depressor, Orbital | Geuder Aktiengesellschaft | 5 |
Showing 12 of 48. All products under Depressor, Orbital
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.