Diamatrix Ltd.
Diamatrix Professional Series Diamond Knife, Standard Tri-Facet, 1.0mm, Angled, Premium Handle
12manufacturers in China registered for this device type
21catalogue 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 | Diamatrix |
|---|---|
| FDA product code | HNN |
| Device type | Knife, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Premarket notification | Exempt |
| Record published | 2022-03-10 |
| Record revised | 2024-12-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N01910 | In distribution | |
| L03412 | In distribution | |
| N04410 | In distribution | |
| N04874 | In distribution | |
| N04645 | In distribution | |
| N05850 | In distribution | |
| N04415 | In distribution | |
| N05490E | In distribution | |
| N04878 | In distribution | |
| N04420E | In distribution | |
| N04871 | In distribution | |
| N04350.8 | In distribution | |
| N05710 | In distribution | |
| N05350.75 | In distribution | |
| N01350 | In distribution | |
| N03502 | In distribution | |
| N04886 | In distribution | |
| N04660 | In distribution | |
| N04886T | In distribution | |
| L03420P | In distribution | |
| N03872 | 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.