Tearduct Catheter
Catheter intended for dacryocystoplasty.
6manufacturers in China registered for this device type
1catalogue number
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 | Numed, Inc., United States |
|---|---|
| FDA product code | HNW |
| Device type | Dilator, Lachrymal |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-20 |
| Record revised | 2024-05-29 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 5 to 45 °C |
| Distribution end date | 2024-05-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 352 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 38 |
| Stephens Instruments | Krishna Imports Inc | 26 |
| 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 |
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.