Duckworth & Kent
Lacrimal Dilator
9manufacturers in China registered for this device type
32catalogue 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 | Duckworth AND Kent Limited |
|---|---|
| FDA product code | HND |
| Device type | Spatula, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Premarket notification | Exempt |
| Record published | 2022-08-31 |
| Record revised | 2023-06-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2024-12-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6-870 | In distribution | |
| 6-836-1 | In distribution | |
| 6-835 | In distribution | |
| 6-855 | In distribution | |
| 6-099-1 | In distribution | |
| 6-098-3 | In distribution | |
| 6-099-2 | In distribution | |
| 6-656-3 | In distribution | |
| 6-180 | In distribution | |
| 6-656 | In distribution | |
| 6-100 | In distribution | |
| 6-099 | In distribution | |
| 6-855-1 | In distribution | |
| 6-656-1 | In distribution | |
| 6-182-2 | In distribution | |
| 6-102 | In distribution | |
| 6-099-3 | In distribution | |
| 6-836 | In distribution | |
| 6-836-2 | In distribution | |
| 6-656-2 | In distribution | |
| 6-258 | Withdrawn | |
| 6-180-1 | Withdrawn | |
| 6-856 | Withdrawn | |
| 6-848 | Withdrawn | |
| 6-656-4 | Withdrawn | |
| 6-101 | Withdrawn | |
| 6-181 | Withdrawn | |
| 6-105-1 | Withdrawn | |
| 6-656-5 | Withdrawn | |
| 6-912 | Withdrawn | |
| 6-099-4 | Withdrawn | |
| 6-107 | Withdrawn |
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 |
| Stephens Instruments | Krishna Imports Inc | 60 |
| Rumex | Rumex International Co. | 54 |
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.