Ambler Surgical
Universal corneal trephine blade handle, see-through, 45.0mm length, fits 5.0mm - 10.00mm short and long trephine blades, screw-type adjustable spread
2manufacturers in China registered for this device type
106catalogue 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 | Ambler Surgical, LLC, 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 | 2021-01-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Troutman corneal punch system set | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Elliot corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Non-vacuum trephine punch | In distribution | |
| Camellin style LASEK trephine | In distribution | |
| Elliot corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Elliot corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Non-vacuum trephine punch | In distribution | |
| Corneal trephine blade | In distribution | |
| Camellin style LASEK trephine | In distribution | |
| Corneal trephine blade | In distribution | |
| Universal corneal trephine blade handle | In distribution | |
| Camellin style LASEK trephine | In distribution | |
| Elliot corneal trephine | In distribution | |
| Searcy chalazion trephine | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Non-vacuum trephine punch | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Non-vacuum trephine punch | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Searcy chalazion trephine | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Castroviejo corneal transplant trephine set | In distribution | |
| Corneal trephine blade | In distribution | |
| Non-vacuum trephine punch | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Castroviejo corneal transplant trephine set | In distribution | |
| Castroviejo corneal transplant trephine set | In distribution | |
| Non-vacuum trephine punch | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Castroviejo corneal transplant trephine set | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Troutman corneal punch system replacement 7.0mm – 9.0mm trephine piston | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Castroviejo corneal transplant trephine set | In distribution | |
| Corneal trephine blade | In distribution | |
| Castroviejo corneal transplant trephine set | In distribution | |
| Camellin LASEK trephine | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Non-vacuum trephine punch | In distribution | |
| Corneal trephine blade | In distribution | |
| Non-vacuum trephine punch | In distribution | |
| Camellin LASEK trephine | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Non-vacuum trephine punch | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Non-vacuum trephine punch | In distribution | |
| Non-vacuum trephine punch | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Non-vacuum trephine punch | In distribution | |
| Non-vacuum trephine punch | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Castroviejo corneal transplant trephine set | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Elliot corneal trephine handle | In distribution | |
| Non-vacuum trephine punch | In distribution | |
| Corneal trephine blade | In distribution | |
| Non-vacuum trephine punch | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Castroviejo corneal transplant trephine set | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Camellin style LASEK trephine | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Troutman corneal punch system replacement Teflon base block | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Corneal trephine blade | In distribution | |
| Castroviejo corneal transplant trephine set | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Coronet | Network Medical Products, Ltd. | 203 |
| 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 |
| V. Mueller | Carefusion 2200, Inc. | 24 |
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.