Sharpoint
Polypropylene, 6-0, 30", CC-1, 3/8C Tapercut Cardio 13mm
12manufacturers in China registered for this device type
162catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (9), Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
| Huaian Frimen Co., Ltd. | Huaian | Jiangsu | Manufacturer | 16 |
| Huaian Wolfram Surgical Instruments | Huaian | Jiangsu | Manufacturer | 14 |
| 2nd Sight Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 1 |
| Shaanxi Xingmao Industry Co., Ltd. | Xi An | Shaanxi | Private-label distributor | 1 |
Record
| Listed by | Surgical Specialties México, S. de R.L. de C.V. |
|---|---|
| FDA product code | HNN |
| Device type | Knife, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Premarket notification | Exempt |
| Record published | 2022-06-30 |
| Record revised | 2023-06-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 6, box of 36, box of 5, box of 12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EX551D | 3/8C Taperpoint 13mm | In distribution |
| 72-0303 | 300MICRON | In distribution |
| 72-2863 | 2.85MM ANG | In distribution |
| 76-5361 | HDL 3.2 ANG | In distribution |
| EX977D | 3/8C Tapercut Cardio 9.3mm | In distribution |
| 75-1720 | 1.7MM X 2.0MM | In distribution |
| 62-3060G | 3.0 mm | In distribution |
| 78-2010G | 1.1MM | In distribution |
| 72-2801 | 2.85MM ST | In distribution |
| 71-1901 | HDL-19GA | In distribution |
| 72-1591 | 15 DEG | In distribution |
| 72-4963 | 4.9MM ANG | In distribution |
| 74-3061 | HDL-3.0MM ANG | In distribution |
| 62-2450G | 2.4 mm | In distribution |
| 72-2961G | 3.0MM ANG | In distribution |
| 62-2250G | 2.2 mm | In distribution |
| 78-2510 | 0.6mm | In distribution |
| 72-1532 | 3MM | In distribution |
| 72-2931 | 3.0MM ANG | In distribution |
| J8726D | 3/8C Tapercut Cardio 9.3mm | In distribution |
| 72-1501G | 15 degree | In distribution |
| 62-2560G | 2.5 mm | In distribution |
| 75-1214 | 1.2MM X 1.4MM | In distribution |
| 72-3035 | 3.0MM CCK | In distribution |
| 72-2861G | 2.85MM ANG | In distribution |
| 62-1501G | 15 Degree | In distribution |
| 72-2763G | 2.75 ANG | In distribution |
| 72-2901 | 3.0MM ST | In distribution |
| 75-2723 | 2.75MM X 3.0MM | In distribution |
| 74-6910 | 1.25MM ANG | In distribution |
| J8762D | 3/8C Taperpoint 9.3mm | In distribution |
| 72-6003 | 600MICRON | In distribution |
| J8713D | 1/2C Taperpoint 17mm | In distribution |
| 72-2961 | 3.0mm | In distribution |
| 72-2261 | 2.2MM ANG | In distribution |
| 71-2061 | ANG-20 GAUGE | In distribution |
| 72-1361 | 1.3MM CCK | In distribution |
| J8806D | 1/2C Taperpoint 22mm | In distribution |
| 72-3231 | 3.2MM ANG | In distribution |
| 72-3212 | 3.2MM ANG | In distribution |
| J8756D | 3/8C Taperpoint 17mm | In distribution |
| 72-2761G | 2.75mm | In distribution |
| 76-5161 | HDL-5.2 ANG | In distribution |
| 76-5261 | 5.2mm | In distribution |
| 72-2531 | 2.5MM ANG | In distribution |
| J8720D | 1/2C Tapercut Cardio 17mm | In distribution |
| 72-2635 | 2.65MM CCK | In distribution |
| 76-4061 | 4.0MM ANG | In distribution |
| EX762D | 1/2C Taperpoint 22mm | In distribution |
| EX563D | 1/2C Tapercut Cardio 26mm | In distribution |
| 72-0401 | 450MICRON | In distribution |
| 72-2661 | 2.65MM ANG | In distribution |
| 72-1001 | 1.0MM ST | In distribution |
| 75-2826 | 2.85MM X 3.75MM | In distribution |
| 72-5503 | 550MICRON | In distribution |
| J8725D | 3/8C Taperpoint 9.3mm | In distribution |
| 72-2735 | 2.75MM CCK | In distribution |
| 75-2824 | 2.85MM X 3.2MM | In distribution |
| J8523D | 1/2C Taperpoint 26mm | In distribution |
| 75-2022 | 2.0 MM X 2.2MM | In distribution |
| J8842D | 1/2C Taperpoint 26mm | In distribution |
| EX523D | 1/2C Taperpoint 26mm | In distribution |
| 68-2010G | 1.0 mm | In distribution |
| E524N | 1×30″ | In distribution |
| 72-2201 | 22.5 DEGREE | In distribution |
| 74-1031 | SHARPTOME FULL HEL-DBL BEV ANG | In distribution |
| J8853D | 1/2C Taperpoint 26mm | In distribution |
| 72-2861 | 2.85MM ANG | In distribution |
| 74-5062 | SHARTOME BL & TIP – BEVEL UP | In distribution |
| J8843D | 1/2C Taperpoint 22mm | In distribution |
| J8554D | 1/2C Taperpoint 13mm | In distribution |
| 72-4501 | 45 DEGREE | In distribution |
| E425N | 1×36″ | In distribution |
| EX763D | 1/2C Taperpoint 17mm | In distribution |
| EX557D | 3/8C Tapercut Cardio 17mm | In distribution |
| 74-1010 | 2.0mm | In distribution |
| 72-2461 | 2.4MM ANG | In distribution |
| 62-2442G | 2.4 mm | In distribution |
| 74-1010G | GUARDED CRESCENT FH-BEVEL UP | In distribution |
| J8707D | 3/8C Tapercut Cardio 9.3mm | In distribution |
| J8975D | 1/2C Tapercut Cardio 26mm | In distribution |
| J8807D | 1/2C Taperpoint 13mm | In distribution |
| 72-2431 | 2.4mm | In distribution |
| J8558D | 3/8C Tapercut Cardio 17mm | In distribution |
| 72-2835 | 2.85MM CCK | In distribution |
| 78-5700 | SCLEROTOME BL & TIP – STRAIGHT | In distribution |
| J8711D | 3/8C Taperpoint 13mm | In distribution |
| J8556D | 1/2C Taperpoint 17mm | In distribution |
| 77-1725 | 1.7mm | In distribution |
| 72-2231G | 2.2MM DBL | In distribution |
| J8455N | 30″/75cm | In distribution |
| 62-2860G | 2.8 mm | In distribution |
| 72-2862 | 2.85MM ANG | In distribution |
| 72-1502 | 15 DEGREE MICRO | In distribution |
| E424N | 1×30″ | In distribution |
| 72-1552 | 5MM | In distribution |
| J8714D | 1/2C Taperpoint 17mm | In distribution |
| 62-2460G | 2.4 mm | In distribution |
| J8976D | 3/8C Tapercut Cardio 17mm | In distribution |
| 72-1501 | 15 DEGREE | In distribution |
| J8435N | 30″/75cm | In distribution |
| J8718D | 1/2C Taperpoint 26mm | In distribution |
| D2552N | Silk 18”/45cm | In distribution |
| 72-2912 | 3.0MM ANG | In distribution |
| EX558D | 1/2C Taperpoint 17mm | In distribution |
| J8709D | 3/8C Taperpoint 13mm | In distribution |
| J8581D | 1/2C Tapercut Cardio 26mm | In distribution |
| 75-2724 | 2.75MM X 3.2MM | In distribution |
| 74-1000 | FULL HDL – STRAIGHT | In distribution |
| 72-3036 | 3.5MM | In distribution |
| 72-2761 | 2.75mm | In distribution |
| EX927D | 3/8C Tapercut Cardio 13mm | In distribution |
| J8521D | 3/8C Taperpoint 13mm | In distribution |
| 72-2863G | 2.85MM ANG | In distribution |
| 72-2561G | 2.5MM ANG | In distribution |
| 72-0503 | 500MICRON | In distribution |
| J8717D | 1/2C Taperpoint 17mm | In distribution |
| 75-2725 | 2.75MM X 3.5MM | In distribution |
| J8533D | 1/2C Taperpoint 26mm | In distribution |
| J8977D | 1/2C Taperpoint 26mm | In distribution |
| J8805D | 3/8C Taperpoint 17mm | In distribution |
| 72-2663 | 2.65MM ANG | In distribution |
| 72-2561 | 2.5MM ANG | In distribution |
| J8534D | 1/2C Taperpoint 26mm | In distribution |
| 78-2310 | 0.8MM | In distribution |
| J8935D | 1/2C Taperpoint 26mm | In distribution |
| J8580D | 1/2C Tapercut Cardio 17mm | In distribution |
| 72-3261 | 3.2mm | In distribution |
| EX556D | 1/2C Taperpoint 17mm | In distribution |
| 72-0301 | 300 MICRO | In distribution |
| 75-2522 | 2.5MM X 2.9MM | In distribution |
| 72-2831 | 2.8MM ANG | In distribution |
| 72-2202 | 22.5 DEGREE | In distribution |
| 74-5000 | SHARPTOME BL & TIP – STRAIGHT | In distribution |
| J8710D | 1/2C Taperpoint 17mm | In distribution |
| 72-2231 | 2.2mm | In distribution |
| 64-1030G | 2.3 mm | In distribution |
| 71-2301 | HDL-23GA | In distribution |
| 62-3042G | 3.0 mm | In distribution |
| 72-2263 | 2.2MM ANG | In distribution |
| J8526D | 1/2C Taperpoint 22mm | In distribution |
| 62-2260G | 2.2 mm | In distribution |
| 72-2762 | 2.75MM ANG | In distribution |
| 72-2661G | 2.65MM ANG | In distribution |
| 71-2001 | 20Ga | In distribution |
| J8702D | 3/8C Taperpoint 9.3mm | In distribution |
| J8522D | 3/8C Taperpoint 9.3mm | In distribution |
| 75-1517 | 1.5MM X 1.7MM | In distribution |
| 78-6810 | NEEDLE BLADE – STRAIGHT | In distribution |
| 72-2431G | 2.4MM DBL | In distribution |
| 72-1531 | 3MM | In distribution |
| 62-2742G | 2.75 mm | In distribution |
| 76-5561 | HDL 5.5 ANG | In distribution |
| 62-2760G | 2.75 mm | In distribution |
| 72-1551 | 20Ga | In distribution |
| J8557D | 3/8C Taperpoint 13mm | In distribution |
| 75-1520 | 1.5 MM X 2.0 MM | In distribution |
| J8555D | 1/2C Taperpoint 13mm | In distribution |
| 72-1831 | 1.8mm Ang | In distribution |
| 62-2542G | 2.5 mm | In distribution |
| 72-2463 | 2.4MM ANG | In distribution |
| 71-2501 | HDL-25GA | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 283 |
| Mani Ophthalmic Knife | Mani, Inc. | 234 |
| Unique Edge | Unique Technologies, Inc. | 186 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 154 |
| Mastel Precision Surgical Instruments, Inc. | Mastel Surgical Inc. | 146 |
| Anodyne Surgical | Psi/Eye-Ko, Inc. | 115 |
| Ophthalmic Knife | Ovation International | 81 |
| Ophthalmic Knife | Katena Products, Inc. | 72 |
| Premier Edge® Microsurgical Knives | Oasis Medical, Inc. | 69 |
| Micro Feather Disposable Ophthalmic Scalpel with plastic handle | Feather Safety Razor Co., Ltd. | 63 |
| ExactEtch | Diamatrix | 63 |
| Micro Feather Ophthalmic Scalpel with aluminum handle | Feather Safety Razor Co., Ltd. | 62 |
Showing 12 of 434. All products under Knife, Ophthalmic
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| SSC- Surgical Specialties Corporation | UDI-DI | 2026-04-23 | Class II | Mixed-up of materials/components | 3.0mm surgical knives labeled and packaged as 2.2mm surgical knives. | 1818 units |
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.