ExactEtch
ExactEtch Restricted Depth Stab Knife, 15 Degree, 5mm, Straight, Blade/Tip Only
12manufacturers in China registered for this device type
63catalogue 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 | 2019-10-24 |
| Record revised | 2023-06-02 (version 2) |
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 |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 6 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2310K | In distribution | |
| 2705K | In distribution | |
| 2162K | In distribution | |
| 2351K | In distribution | |
| 2320K | In distribution | |
| 2162K | In distribution | |
| 2376K | In distribution | |
| 2405K | In distribution | |
| 2565K | In distribution | |
| 2410K | In distribution | |
| 2305K | In distribution | |
| 2210NS | In distribution | |
| 2957K | In distribution | |
| 2220K | In distribution | |
| 2715K | In distribution | |
| 2510K | In distribution | |
| 2352NS | In distribution | |
| 2115NS | In distribution | |
| 2130K | In distribution | |
| 2411K | In distribution | |
| 2505K | In distribution | |
| 2725K | In distribution | |
| 2180K | In distribution | |
| 2969K | In distribution | |
| 2355K | In distribution | |
| 2170K | In distribution | |
| 2115K | In distribution | |
| 2710K | In distribution | |
| 2378K | In distribution | |
| 2330K | In distribution | |
| 2126K | In distribution | |
| 2150K | In distribution | |
| 2185K | In distribution | |
| 2520K | In distribution | |
| 2342K | In distribution | |
| 2325K | In distribution | |
| 2380K | In distribution | |
| 2205K | In distribution | |
| 2340K | In distribution | |
| 2350K | In distribution | |
| 2105NS | In distribution | |
| 2163K | In distribution | |
| 2315K | In distribution | |
| 2125K | In distribution | |
| 2188K | In distribution | |
| 2560K | In distribution | |
| 2352K | In distribution | |
| 2105K | In distribution | |
| 2300K | In distribution | |
| 2374K | In distribution | |
| 2415K | In distribution | |
| 2120K | In distribution | |
| 2310NS | In distribution | |
| 2131K | In distribution | |
| 2720K | In distribution | |
| 2620K | In distribution | |
| 2515K | In distribution | |
| 2341K | In distribution | |
| 2210K | In distribution | |
| 2160K | In distribution | |
| 2175K | In distribution | |
| 2110K | In distribution | |
| 2700K | 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 |
| Micro Feather Ophthalmic Scalpel with aluminum handle | Feather Safety Razor Co., Ltd. | 62 |
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.