Vortex Surgical Inc
TID Pharos Illuminated Depressor - Bausch and Lomb Stellaris Box of 5
3manufacturers in China registered for this device type
4catalogue 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 | Vortex Surgical, Inc., United States |
|---|---|
| FDA product code | HNX |
| Device type | Depressor, Orbital |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| VS0800 | 5 | In distribution | |
| VS0801A | 5 | In distribution | |
| VS0802 | 5 | In distribution | |
| VS0801B | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Scleral Depressors | Aurora Surgical, LLC | 13 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 10 |
| 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 |
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.