Duckworth & Kent
Incision Marker
7manufacturers in China registered for this device type
33catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Hubei (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 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| 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 |
Record
| Listed by | Duckworth AND Kent Limited |
|---|---|
| FDA product code | HMR |
| Device type | Marker, Ocular |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4570 |
| Premarket notification | Exempt |
| Record published | 2022-08-31 |
| Record revised | 2023-08-03 (version 3) |
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 |
|---|---|---|
| 9-846 | In distribution | |
| 9-729-1 | In distribution | |
| 9-840 | In distribution | |
| 9-732 | In distribution | |
| 9-864-1 | In distribution | |
| 9-830 | In distribution | |
| 9-734 | In distribution | |
| 9-841 | In distribution | |
| 9-518-2 | In distribution | |
| 9-841-1 | In distribution | |
| 9-840-1 | In distribution | |
| 9-733 | Withdrawn | |
| 9-518-4 | Withdrawn | |
| 9-841-2 | Withdrawn | |
| 9-788 | Withdrawn | |
| 9-749 | Withdrawn | |
| 9-779 | Withdrawn | |
| 9-729 | Withdrawn | |
| 9-730 | Withdrawn | |
| 9-781 | Withdrawn | |
| 9-841-4 | Withdrawn | |
| 9-789W-1 | Withdrawn | |
| 9-840-3 | Withdrawn | |
| 9-778 | Withdrawn | |
| 9-855 | Withdrawn | |
| 9-845-2 | Withdrawn | |
| 9-518-1 | Withdrawn | |
| 9-831 | Withdrawn | |
| 9-518-3 | Withdrawn | |
| 9-841-3 | Withdrawn | |
| 9-842-1 | Withdrawn | |
| 9-854R | Withdrawn | |
| 9-781W | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 196 |
| Walcott Rx Products | Walcott Rx Product Inc | 188 |
| Mastel Precision Surgical Instruments, Inc. | Mastel Surgical Inc. | 148 |
| MR Phaco | Crestpoint Management Ltd. | 125 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 122 |
| Millennium | Avalign Technologies, Inc. | 90 |
| Marker, Ocular | Katena Products, Inc. | 51 |
| Surgical Direct | Surgical Direct, Inc. | 40 |
| Rumex | Rumex International Co. | 37 |
| Epsilon USA | Epsilon EYE Care PVT., Ltd. | 28 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 27 |
| Mrk, Ocular | Katena Products, Inc. | 26 |
Showing 12 of 213. All products under Marker, Ocular
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.