Duckworth & Kent
19 catalogue numbers from 33-203, listed by Duckworth AND Kent Limited, under Needle, Ophthalmic Suturing. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
19catalogue numbers in this listing
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ophsurin Co., Ltd. | Suqian | Jiangsu | Contract manufacturer | 6 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| 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 | HNM |
| Device type | Needle, Ophthalmic Suturing |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Premarket notification | Exempt |
| Record published | 2022-08-31 |
| Record revised | 2023-03-06 (version 2) |
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 | 2024-05-21 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 33-203 | In distribution | |
| 33-225 | In distribution | |
| 33-303 | In distribution | |
| 3-201 | In distribution | |
| 3-223 | In distribution | |
| 6-194-2 | In distribution | |
| 3-206 | In distribution | |
| 3-203 | In distribution | |
| 3-205 | In distribution | |
| 3-303 | In distribution | |
| 3-302 | In distribution | |
| 3-202 | In distribution | |
| 3-422 | In distribution | |
| 3-208 | Withdrawn | |
| 33-223 | Withdrawn | |
| 3-222 | Withdrawn | |
| 33-222 | Withdrawn | |
| 3-423 | Withdrawn | |
| 33-202 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 50 |
| MR Phaco | Crestpoint Management Ltd. | 37 |
| Epsilon USA | Epsilon EYE Care PVT., Ltd. | 36 |
| V. Mueller | Steris Corporation | 22 |
| Aesculap | Aesculap AG | 20 |
| Pilling | Teleflex Medical LLC | 19 |
| Moria | Moria, Inc. | 18 |
| Avalign | Avalign Technologies, Inc. | 12 |
| Medetz Surgical Instruments | Medetz Surgical Instruments | 10 |
| Novo Surgical | Novo Surgical, Inc. | 7 |
| Barraquer Needle Holder, Curved | Bausch & Lomb Incorporated | 6 |
| Castroviejo Needle Holder, Straight | Bausch & Lomb Incorporated | 5 |
Showing 12 of 31. All products under Needle, Ophthalmic Suturing
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.