Bausch + Lomb
Combo-Manipulator Grayson Titn
9manufacturers in China registered for this device type
83catalogue 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 | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | HND |
| Device type | Spatula, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-11-21 |
| Record revised | 2025-09-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E0578 L | In distribution | |
| E0708 | In distribution | |
| E1091 | In distribution | |
| E3150 | In distribution | |
| E0488 | In distribution | |
| SP7-74141 | In distribution | |
| ET0732 | In distribution | |
| E0616 | In distribution | |
| E9111 | In distribution | |
| SP7-62653 | In distribution | |
| E0747 | In distribution | |
| E0606 | In distribution | |
| SP7-73866 | In distribution | |
| ET0651 | In distribution | |
| E3145 | In distribution | |
| E0485 | In distribution | |
| E0707 | In distribution | |
| E0481 | In distribution | |
| E0704 | In distribution | |
| E0700 | In distribution | |
| E6003 | In distribution | |
| SP7-62478 | In distribution | |
| ET0738 | In distribution | |
| SP7-74835 | In distribution | |
| ET0736 | In distribution | |
| SP7-65177 | In distribution | |
| E4926 | In distribution | |
| E0484 | In distribution | |
| E0474 | In distribution | |
| E0486 M | In distribution | |
| E0479 | In distribution | |
| E3125 | In distribution | |
| E2998 | In distribution | |
| E9133 | In distribution | |
| SP7-74952 | In distribution | |
| E0646 | In distribution | |
| E0570 N | In distribution | |
| E3122 | In distribution | |
| E0741 | In distribution | |
| E3046 | In distribution | |
| E0785 | In distribution | |
| E0608 | In distribution | |
| E9102 | In distribution | |
| E0485 C | In distribution | |
| E0636 | In distribution | |
| E0622 | In distribution | |
| E0578 R | In distribution | |
| E0647 | In distribution | |
| E0487 M | In distribution | |
| E4937 | In distribution | |
| E2040 | In distribution | |
| E9110 | In distribution | |
| E0485.25 | In distribution | |
| E0642 | In distribution | |
| E0621 | In distribution | |
| E6002 | In distribution | |
| ET1106 | In distribution | |
| E0640 | In distribution | |
| E0740 | In distribution | |
| E0529 | In distribution | |
| E6000 | In distribution | |
| SP7-70118 | In distribution | |
| E2999 | In distribution | |
| E4937 M | In distribution | |
| ET0703 | In distribution | |
| E3146 | In distribution | |
| E0489 | In distribution | |
| E0788 | In distribution | |
| E0609 | In distribution | |
| E3002 | In distribution | |
| E0706 | In distribution | |
| E4430 | In distribution | |
| E4933 | In distribution | |
| E0757 | In distribution | |
| ET0584 | In distribution | |
| E0712 | In distribution | |
| E0730 | In distribution | |
| E0629 | In distribution | |
| E0729 | In distribution | |
| E3143 | In distribution | |
| E0789 | In distribution | |
| ET0734 | In distribution | |
| E3142 | 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 |
| Sklar® | Sklar Corporation | 62 |
| Stephens Instruments | Krishna Imports Inc | 60 |
| 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.