MR Phaco
8 catalogue numbers from PH6089, listed by Crestpoint Management Ltd., United States, under Dilator, Lachrymal. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
8catalogue 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 | Crestpoint Management Ltd., United States |
|---|---|
| FDA product code | HNW |
| Device type | Dilator, Lachrymal |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2025-05-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PH6089 | In distribution | |
| PH6086 | In distribution | |
| PH6085T | In distribution | |
| PH6090 | In distribution | |
| PH6085 | In distribution | |
| PH6091 | In distribution | |
| PH6088 | In distribution | |
| PH6087 | In distribution |
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 |
| 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.