Stephens Instruments
Castroviejo Lacrimal Dilator, Double Ended, Med/Fine Tip, Single Use, 10/Box
6manufacturers in China registered for this device type
26catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| 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 |
Record
| Listed by | Krishna Imports Inc |
|---|---|
| FDA product code | HNW |
| Device type | Dilator, Lachrymal |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Premarket notification | Exempt |
| Record published | 2020-09-22 |
| Record revised | 2023-02-20 (version 3) |
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 |
|---|---|---|
| S8-1115 | In distribution | |
| S8-1025 | In distribution | |
| S8-1200 | In distribution | |
| S8-1105 | In distribution | |
| S8-1090 | In distribution | |
| S8-1040 | In distribution | |
| SSD8 1015 | In distribution | |
| S8-1010 | In distribution | |
| S8-1015 | In distribution | |
| S8-1030 | In distribution | |
| S8-1035M | In distribution | |
| S8-1070 | In distribution | |
| S8-1020 | In distribution | |
| S8-1045 | In distribution | |
| S8-1100 | In distribution | |
| S8-1205 | In distribution | |
| S8-1075 | In distribution | |
| S8-1110 | In distribution | |
| S8-1095 | In distribution | |
| S8-1020M | In distribution | |
| S8-1210 | In distribution | |
| S8-1035 | In distribution | |
| S8-1065 | In distribution | |
| SSD8 1070 | In distribution | |
| S8-1085 | In distribution | |
| S8-1080 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 38 |
| Sklar | Sklar Corporation | 22 |
| V. Mueller | Steris Corporation | 20 |
| Millennium | Avalign Technologies, Inc. | 16 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 13 |
| Princeton | Princeton Medical Group, Inc. | 9 |
| Pilling | Teleflex Medical LLC | 9 |
| MR Phaco | Crestpoint Management Ltd. | 8 |
| Aesculap | Aesculap AG | 8 |
| Avalign | Avalign Technologies, Inc. | 8 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 8 |
| Walcott Rx Products | Walcott Rx Product Inc | 8 |
Showing 12 of 66. All products under Dilator, Lachrymal
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.