Ambler Surgical
TransLite™ modified scleral depressor, 4 7/8'', for transillumination of the sclera, round handle, accepts Peregrine Surgical light fibers. Includes a free 1665E sterilization tray with…
TransLite™ modified scleral depressor, 4 7/8”, for transillumination of the sclera, round handle, accepts Peregrine Surgical light fibers. Includes a free 1665E sterilization tray with each depressor ordered.
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 | Ambler Surgical, LLC, United States |
|---|---|
| FDA product code | HNX |
| Device type | Depressor, Orbital |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2021-01-04 |
| Record revised | 2023-08-03 (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 |
|---|---|---|
| Schepens scleral depressor – size 12 large thimble | In distribution | |
| Wilder scleral depressor | In distribution | |
| Flynn lens loop/scleral depressor | In distribution | |
| Urretts-Zavalia depressor and fixation pick | In distribution | |
| TransLite™ modified scleral depressor | In distribution | |
| Schepens scleral depressor – size 10 medium thimble | In distribution | |
| Schepens scleral depressor – size 8 small thimble | 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 |
| 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.