Mastel Precision Surgical Instruments, Inc.
President TTE UltraThin Trunc. Triple Edge, Nichamin Ext. .600mm Preset
12manufacturers in China registered for this device type
146catalogue 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 | Mastel Surgical Inc., United States |
|---|---|
| FDA product code | HNN |
| Device type | Knife, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-08-15 |
| Record revised | 2025-09-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | serial number |
| Distribution end date | 2024-12-10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10.301.2008 | In distribution | |
| 10.305.4029 | In distribution | |
| 10.303.2023 | In distribution | |
| 10.302.2008 | In distribution | |
| 10.302.2022 | In distribution | |
| 11.317.1011 | In distribution | |
| 10.306.4074 | In distribution | |
| 10.310.3013-55 | In distribution | |
| 10.310.3003 | In distribution | |
| 12.321.1089 | In distribution | |
| 10.310.3086 | In distribution | |
| 11.315.2016 | In distribution | |
| 11.316.2089 | In distribution | |
| 10.306.4076 | In distribution | |
| 10.301.2006 | In distribution | |
| 10.301.2004 | In distribution | |
| 10.310.3086-35 | In distribution | |
| 11.315.2089 | In distribution | |
| 10.310.3086-30 | In distribution | |
| 10.305.4035 | In distribution | |
| 11.315.1089 | In distribution | |
| 10.312.1089 | In distribution | |
| 10.302.2004 | In distribution | |
| 10.310.3003-30 | In distribution | |
| 10.301.2003 | In distribution | |
| 10.307.4081 | In distribution | |
| 10.310.3003-25 | In distribution | |
| 10.310.3013-30 | In distribution | |
| 11.316.1089 | In distribution | |
| 12.321.2016 | In distribution | |
| 10.302.2020 | In distribution | |
| 11.317.3011 | In distribution | |
| 10.309.3003-65 | In distribution | |
| 11.316.3089 | In distribution | |
| 10.305.4039 | In distribution | |
| 11.317.1089 | In distribution | |
| 10.306.4062 | In distribution | |
| 10.305.4048 | In distribution | |
| 10.306.4065 | In distribution | |
| 10.301.2011 | In distribution | |
| 10.309.3004-60 | In distribution | |
| 10.303.2026 | In distribution | |
| 11.316.3011 | In distribution | |
| 10.302.2001 | In distribution | |
| 11.317.3016 | In distribution | |
| 11.315.3016 | In distribution | |
| 10.310.3013-35 | In distribution | |
| 10.301.2013 | In distribution | |
| 10.304.4027 | In distribution | |
| 10.310.3086-60 | In distribution | |
| 10.310.3086-25 | In distribution | |
| 11.319.6091 | In distribution | |
| 12.321.1016 | In distribution | |
| 12.321.2089 | In distribution | |
| 10.311.1087 | In distribution | |
| 10.302.2015 | In distribution | |
| 10.302.2014 | In distribution | |
| 10.306.4067 | In distribution | |
| 11.316.1016 | In distribution | |
| 10.305.4031 | In distribution | |
| 10.301.2005 | In distribution | |
| 10.306.4052 | In distribution | |
| 10.305.4049 | In distribution | |
| 12.323.1016 | In distribution | |
| 10.305.4041 | In distribution | |
| 10.309.3003-60 | In distribution | |
| 10.308.3004 | In distribution | |
| 10.302.2090 | In distribution | |
| 10.307.4084 | In distribution | |
| 10.306.4058 | In distribution | |
| 10.307.4085 | In distribution | |
| 11.317.1016 | In distribution | |
| 10.303.2024 | In distribution | |
| 11.315.3011 | In distribution | |
| 10.306.4069 | In distribution | |
| 10.303.2025 | In distribution | |
| 10.301.2002 | In distribution | |
| 10.308.3016 | In distribution | |
| 10.302.2009 | In distribution | |
| 10.305.4050 | In distribution | |
| 11.318.5016 | In distribution | |
| 10.302.2013 | In distribution | |
| 11.315.1011 | In distribution | |
| 10.305.4033 | In distribution | |
| 10.310.3003-55 | In distribution | |
| 10.310.3003-60 | In distribution | |
| 11.317.2089 | In distribution | |
| 11.316.2011 | In distribution | |
| 11.317.2016 | In distribution | |
| 10.309.3004-55 | In distribution | |
| 10.307.4077 | In distribution | |
| 10.309.3016 | In distribution | |
| 12.322.1016 | In distribution | |
| 10.302.2019 | In distribution | |
| 10.306.4072 | In distribution | |
| 10.310.3086-55 | In distribution | |
| 10.306.4054 | In distribution | |
| 10.304.4028 | In distribution | |
| 10.301.2009 | In distribution | |
| 10.307.4079 | In distribution | |
| 10.310.3013 | In distribution | |
| 10.302.2003 | In distribution | |
| 10.306.4060 | In distribution | |
| 10.301.2010 | In distribution | |
| 12.324.1092 | In distribution | |
| 12.322.1089 | In distribution | |
| 10.302.2018 | In distribution | |
| 10.305.4045 | In distribution | |
| 10.305.4047 | In distribution | |
| 10.308.3003 | In distribution | |
| 11.317.2011 | In distribution | |
| 10.305.4043 | In distribution | |
| 10.310.3013-60 | In distribution | |
| 10.306.4064 | In distribution | |
| 10.310.3003-65 | In distribution | |
| 10.302.2021 | In distribution | |
| 10.302.2002 | In distribution | |
| 10.302.2016 | In distribution | |
| 11.315.2011 | In distribution | |
| 10.306.4075 | In distribution | |
| 10.302.2005 | In distribution | |
| 10.309.3003-55 | In distribution | |
| 10.310.3003-35 | In distribution | |
| 10.306.4051 | In distribution | |
| 10.307.4083 | In distribution | |
| 10.305.4037 | In distribution | |
| 11.317.3089 | In distribution | |
| 10.309.3004 | In distribution | |
| 10.301.2001 | In distribution | |
| 11.315.1016 | In distribution | |
| 11.315.3089 | In distribution | |
| 10.309.3003 | In distribution | |
| 11.316.1011 | In distribution | |
| 10.310.3013-25 | In distribution | |
| 11.316.2016 | In distribution | |
| 10.306.4056 | In distribution | |
| 10.301.2007 | In distribution | |
| 10.306.4053 | In distribution | |
| 10.306.4071 | In distribution | |
| 10.302.2006 | In distribution | |
| 11.316.3016 | In distribution | |
| 10.306.4073 | In distribution | |
| 10.311.1088 | In distribution | |
| 12.323.2016 | Withdrawn | |
| 10.308.3016-55 | Withdrawn | |
| 12.325.1092 | Withdrawn |
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 |
| 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
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.