Schepens Scleral Depressor Small
Catalogue number AE-1705, listed by Katena Products, Inc., United States, under Depressor, Orbital. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
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 | Katena Products, 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 | 2022-12-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AE-1705 | 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.