Stylus
Guarded Slit Knife Full HDL-3.2MM ANG
12manufacturers in China registered for this device type
39catalogue 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 |
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, bag |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 52-2763G | 2.75MM | In distribution |
| 52-5503 | 550MICRON | In distribution |
| 55-1214 | 1.2MM X 1.4MM | In distribution |
| 52-3235 | 3.2MM | In distribution |
| 56-3461 | 3.5MM ANG | In distribution |
| 52-2801 | 2.85MM | In distribution |
| 52-4502 | 45 DEG | In distribution |
| 52-1761W | 2.2MM | In distribution |
| 52-2531 | 2.5MM ANG | In distribution |
| 58-2010G | 1.1MM | In distribution |
| 52-3262 | 3.2MM | In distribution |
| 58-2019W | 1.4MM | In distribution |
| 52-2461 | 2.4MM ANG | In distribution |
| 55-3226 | 3.2MM X 3.75MM | In distribution |
| 52-2231G | 2.2MM | In distribution |
| 52-2562 | 2.5MM ANG | In distribution |
| 52-1761 | 1.8MM ANG | In distribution |
| 52-2863G | 2.85MM | In distribution |
| 52-2861G | 2.85MM | In distribution |
| 54-1010G | 2.0MM | In distribution |
| 52-1501G | 15 DEGREE | In distribution |
| 54-5000 | CRESCENT KNF | In distribution |
| 55-1520W | 1.5 MM X 2.0 MM | In distribution |
| 52-2431G | 2.4MM | In distribution |
| 92-9003 | KNIFE HANDLE NON-STER-LONG | In distribution |
| 52-3212 | 3.2MM | In distribution |
| 55-1720W | 1.7MM X 2.0MM | In distribution |
| 52-1863 | 1.8MM ANG | In distribution |
| 52-2761G | 2.75MM | In distribution |
| 54-6910 | 1.25MM ANG | In distribution |
| 52-3001 | 30deg | In distribution |
| 52-2961G | 3.0MM | In distribution |
| 52-1861 | 1.8MM ANG | In distribution |
| 52-2911 | 3.0MM | In distribution |
| 52-3261G | 3.2MM | In distribution |
| 52-2661G | 2.65MM | In distribution |
| 52-1661 | 1.6MM CCK | In distribution |
| 52-9003 | KNIFE HANDLE NON-STER-LONG | In distribution |
| 52-2561G | 2.5MM | 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 |
| Sharpoint | Surgical Specialties México, S. de R.L. de C.V. | 162 |
| 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 |
Showing 12 of 434. All products under Knife, 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.