Corneal Trephine Handle
13 catalogue numbers from 12-2269, listed by Sontec Instruments, Inc., United States, under Trephine, Manual, Ophthalmic. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
13catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1). 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 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Record
| Listed by | Sontec Instruments, Inc., United States |
|---|---|
| FDA product code | HRH |
| Device type | Trephine, Manual, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2018-09-18 |
| Record revised | 2026-03-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization, Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2023-07-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12-2269 | For 5.5 Millimeter Blade | Withdrawn |
| 12-2265 | Withdrawn | |
| 12-2268 | For 5 Millimeter Blade | Withdrawn |
| 12-2281 | For 10 Millimeter Blade | Withdrawn |
| 12-2271 | For 6.5 Millimeter Blade | Withdrawn |
| 12-2279 | Withdrawn | |
| 12-2266 | Withdrawn | |
| 12-2267 | Withdrawn | |
| 12-2283 | Withdrawn | |
| 12-2273 | Withdrawn | |
| 12-2264 | Withdrawn | |
| 12-2277 | For 8.5 Millimeter Blade | Withdrawn |
| 12-2263 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Coronet | Network Medical Products, Ltd. | 203 |
| Ambler Surgical | Ambler Surgical, LLC | 106 |
| Surgistar | Surgistar, Inc. | 94 |
| Corneal Trephine | Katena Products, Inc. | 72 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 53 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 50 |
| Coronet | CorneaGen | 44 |
| Novo Surgical | Novo Surgical, Inc. | 30 |
| Eyetec | Network Medical Products, Ltd. | 28 |
| Surtex | Surtex Instruments Ltd | 27 |
| Beaver | Beaver-Visitec International, Ltd | 26 |
| Corneal Trephine Blade | Sontec Instruments, Inc. | 25 |
Showing 12 of 98. All products under Trephine, Manual, Ophthalmic
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.