Phaco Accessory Set
PA603952 COOLFLOW 20G Sleeve, beige
2manufacturers in China registered for this device type
14catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
| Shenzhen Create Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
Record
| Listed by | Medicel AG, Switzerland |
|---|---|
| FDA product code | KYG |
| Device type | Device, Irrigation, Ocular Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4360 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-12-01 |
| Record revised | 2024-10-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2024-10-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PA603902 | In distribution | |
| PA603951 | Withdrawn | |
| PA6039023 | Withdrawn | |
| PA603904 | Withdrawn | |
| PA603952 | Withdrawn | |
| PA603904 | Withdrawn | |
| PA603901 | Withdrawn | |
| PA603952 | Withdrawn | |
| PA603901 | Withdrawn | |
| PA603953 | Withdrawn | |
| PA603902 | Withdrawn | |
| PA603953 | Withdrawn | |
| PA603903 | Withdrawn | |
| PA603951 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 137 |
| Rumex | Rumex International Co. | 20 |
| Anodyne Surgical | Psi/Eye-Ko, Inc. | 17 |
| Device, Irrigation, Ocular Surgery | Geuder Aktiengesellschaft | 17 |
| High pressure injection/aspiration system for syringe – Connector A | Aktive SRL | 16 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 11 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 9 |
| High pressure injection/aspiration system with syringe – Connector E | Aktive SRL | 8 |
| Medetz Surgical Instruments | Medetz Surgical Instruments | 7 |
| Device, Irrigation, Ocular Surgery | Microvision, Inc. | 3 |
| MorTan | Zien Medical Technologies LLC | 3 |
| Disposable Infusion Cannula, 6.0 mm. | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 2 |
Showing 12 of 114. All products under Device, Irrigation, Ocular Surgery
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.