Stephens Instruments
Nagahara Phaco Chopper, Nucleus Splitter, Nucleus Splitter, Blunt Tip, Single Use, 10/Box
9manufacturers in China registered for this device type
60catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Ophsurin Co., Ltd. | Suqian | Jiangsu | Contract manufacturer | 6 |
| 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 |
| 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 |
Record
| Listed by | Krishna Imports Inc |
|---|---|
| FDA product code | HND |
| Device type | Spatula, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Premarket notification | Exempt |
| Record published | 2020-09-23 |
| Record revised | 2020-12-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Room Temperature |
| Packaging | Box of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ST4-1140 | In distribution | |
| S1-1275 | In distribution | |
| S4-1154 | In distribution | |
| S4-1535 | In distribution | |
| S4-1040 | In distribution | |
| S4-1446 | In distribution | |
| S4-1610 | In distribution | |
| S4-1557 | In distribution | |
| S4-1090 | In distribution | |
| S4-1080 | In distribution | |
| SSD4 1550 | In distribution | |
| S4-1396 | In distribution | |
| S4-1150 | In distribution | |
| S4-1605 | In distribution | |
| S4-1095 | In distribution | |
| S4-1700 | In distribution | |
| S4-1116 | In distribution | |
| SSD4 1605 | In distribution | |
| S4-1155 | In distribution | |
| S4-1615 | In distribution | |
| ST4-1040 | In distribution | |
| S4-1125 | In distribution | |
| S4-1120 | In distribution | |
| S4-1675 | In distribution | |
| S4-1396M | In distribution | |
| S4-1665 | In distribution | |
| S4-1065 | In distribution | |
| S4-1550 | In distribution | |
| ST4-1720 | In distribution | |
| S4-1130 | In distribution | |
| S4-1055 | In distribution | |
| S4-1060 | In distribution | |
| S4-1715 | In distribution | |
| S4-1558 | In distribution | |
| S4-1135 | In distribution | |
| S4-1710 | In distribution | |
| S4-1067 | In distribution | |
| S4-1153 | In distribution | |
| S4-1600 | In distribution | |
| S4-1085 | In distribution | |
| S4-1105 | In distribution | |
| S4-1556 | In distribution | |
| S4-1540 | In distribution | |
| S4-1560 | In distribution | |
| S4-1670 | In distribution | |
| S4-1553 | In distribution | |
| S4-1117 | In distribution | |
| S4-1720 | In distribution | |
| S4-1100 | In distribution | |
| S4-1554 | In distribution | |
| S4-1045 | In distribution | |
| S4-1551 | In distribution | |
| S4-1660 | In distribution | |
| S4-1559 | In distribution | |
| ST4-1555 | In distribution | |
| S4-1075 | In distribution | |
| SSD4 1068 | In distribution | |
| SSD4 1116 | In distribution | |
| S4-1140 | In distribution | |
| S4-1039 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epsilon USA | Epsilon EYE Care PVT., Ltd. | 209 |
| Surgical Direct | Surgical Direct, Inc. | 201 |
| Ambler Surgical | Ambler Surgical, LLC | 164 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 155 |
| Oph.Spatula | Katena Products, Inc. | 132 |
| Ophthalmic Spatula | Katena Products, Inc. | 128 |
| Millennium | Avalign Technologies, Inc. | 103 |
| MR Phaco | Crestpoint Management Ltd. | 85 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 83 |
| Sklar® | Sklar Corporation | 62 |
| Rumex | Rumex International Co. | 54 |
| Opthalmic Spatula | Ovation International | 50 |
Showing 12 of 401. All products under Spatula, 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.