Corneal Trephine
Lasek Trephine 9MM AND Well Double Ended
2manufacturers in China registered for this device type
72catalogue 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 | Katena Products, Inc., United States |
|---|---|
| FDA product code | HRH |
| Device type | Trephine, Manual, Ophthalmic |
| 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 | 2020-09-14 |
| Record revised | 2022-12-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Sizes | Outer diameter 6 to 16 mm; lumen/inner diameter 1 to 14 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K20-2152 | Outer Diameter 6.5 mm | In distribution |
| K2-8020 | Lumen/Inner Diameter 7.5 mm | In distribution |
| K2-7510 | Lumen/Inner Diameter 1.5 mm | In distribution |
| K20-2050 | Outer Diameter 6 mm | In distribution |
| K2-8021 | Lumen/Inner Diameter 7.75 mm | In distribution |
| K20-2107 | Outer Diameter 7.75 mm | In distribution |
| K20-2161 | Outer Diameter 8.75 mm | In distribution |
| K20-2079 | Outer Diameter 8.25 mm | In distribution |
| K2-8046 | Lumen/Inner Diameter 14 mm | In distribution |
| K2-8028 | Lumen/Inner Diameter 9.5 mm | In distribution |
| K20-2106 | Outer Diameter 7.5 mm | In distribution |
| K20-2153 | Outer Diameter 6.75 mm | In distribution |
| K20-2113 | Outer Diameter 9.25 mm | In distribution |
| K20-2078 | Outer Diameter 8 mm | In distribution |
| K2-7812 | Lumen/Inner Diameter 9 mm | In distribution |
| K20-2104 | Outer Diameter 7 mm | In distribution |
| K20-2074 | Outer Diameter 7 mm | In distribution |
| K20-2084 | Outer Diameter 9.5 mm | In distribution |
| K2-7832 | In distribution | |
| K20-2105 | Outer Diameter 7.25 mm | In distribution |
| K20-2160 | Outer Diameter 8.5 mm | In distribution |
| K20-2077 | Outer Diameter 7.75 mm | In distribution |
| K20-2159 | Outer Diameter 8.25 mm | In distribution |
| K20-2157 | Outer Diameter 7.75 mm | In distribution |
| K20-2158 | Outer Diameter 8 mm | In distribution |
| K20-2080 | Outer Diameter 8.5 mm | In distribution |
| K20-2110 | Outer Diameter 8.5 mm | In distribution |
| K20-2057 | Outer Diameter 7.75 mm | In distribution |
| K2-8017 | Lumen/Inner Diameter 6.75 mm | In distribution |
| K20-2055 | Outer Diameter 7.25 mm | In distribution |
| K20-2056 | Outer Diameter 7.5 mm | In distribution |
| K20-2061 | Outer Diameter 8.75 mm | In distribution |
| K20-2075 | Outer Diameter 7.25 mm | In distribution |
| K20-2060 | Outer Diameter 8.5 mm | In distribution |
| K20-2150 | Outer Diameter 6 mm | In distribution |
| K20-2164 | Outer Diameter 9.5 mm | In distribution |
| K20-2054 | Outer Diameter 7 mm | In distribution |
| K20-2083 | Outer Diameter 9.25 mm | In distribution |
| K20-2052 | Outer Diameter 6.5 mm | In distribution |
| K20-2076 | Outer Diameter 7.5 mm | In distribution |
| K20-2059 | Outer Diameter 8.25 mm | In distribution |
| K20-2109 | Outer Diameter 8.25 mm | In distribution |
| K20-2156 | Outer Diameter 7.5 mm | In distribution |
| K20-2062 | Outer Diameter 9 mm | In distribution |
| K20-2070 | Outer Diameter 6 mm | In distribution |
| K2-8026 | Lumen/Inner Diameter 9 mm | In distribution |
| K20-2073 | Outer Diameter 6.75 mm | In distribution |
| K20-2058 | Outer Diameter 8 mm | In distribution |
| K20-2100 | Outer Diameter 6 mm | In distribution |
| K20-2103 | Outer Diameter 6.75 mm | In distribution |
| K20-2155 | Outer Diameter 7.25 mm | In distribution |
| K2-7500 | Lumen/Inner Diameter 1 mm | In distribution |
| K2-7830 | In distribution | |
| K20-2108 | Outer Diameter 8 mm | In distribution |
| K20-2154 | Outer Diameter 7 mm | In distribution |
| K2-7520 | Lumen/Inner Diameter 2 mm | In distribution |
| K20-2111 | Outer Diameter 8.75 mm | In distribution |
| K20-2081 | Outer Diameter 8.75 mm | In distribution |
| K20-2082 | Outer Diameter 9 mm | In distribution |
| K2-8024 | Lumen/Inner Diameter 8.5 mm | In distribution |
| K20-2162 | Outer Diameter 9 mm | In distribution |
| K20-2072 | Outer Diameter 6.5 mm | In distribution |
| K2-8016 | Lumen/Inner Diameter 6.5 mm | In distribution |
| K2-8023 | Lumen/Inner Diameter 8.25 mm | In distribution |
| K2-8025 | Lumen/Inner Diameter 8.75 mm | In distribution |
| K2-8019 | Lumen/Inner Diameter 7.25 mm | In distribution |
| K2-7810 | Lumen/Inner Diameter 8 mm | In distribution |
| K2-8018 | Lumen/Inner Diameter 7 mm | In distribution |
| K20-2102 | Outer Diameter 6.5 mm | In distribution |
| K20-2178 | Outer Diameter 16 mm | In distribution |
| K20-2114 | Outer Diameter 9.5 mm | In distribution |
| K20-2112 | Outer Diameter 9 mm | 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 |
| 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.