Ophtec
Ophtec Long Handled Trephine - 6.75mm - Carton
2manufacturers in China registered for this device type
18catalogue 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 | Network Medical Products, Ltd., United Kingdom |
|---|---|
| FDA product code | HRH |
| Device type | Trephine, Manual, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-08-30 |
| Record revised | 2020-03-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OT16825 | In distribution | |
| OT16850 | In distribution | |
| OT16775 | In distribution | |
| OT16925 | In distribution | |
| OT161050 | In distribution | |
| OT16600 | In distribution | |
| OT16950 | In distribution | |
| OT16800 | In distribution | |
| OT16750 | In distribution | |
| OT16875 | In distribution | |
| OT16725 | In distribution | |
| OT161000 | In distribution | |
| OT16625 | In distribution | |
| OT16975 | In distribution | |
| OT16650 | In distribution | |
| OT16675 | In distribution | |
| OT16700 | In distribution | |
| OT16900 | In distribution |
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.