High Pressure Injection/aspiration System With Syringe – Connector E
8 catalogue numbers from AK-0383/ES, listed by Aktive SRL, Italy, under Device, Irrigation, Ocular Surgery. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
8catalogue 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 | Aktive SRL, Italy |
|---|---|
| FDA product code | KYG |
| Device type | Device, Irrigation, Ocular Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4360 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 5 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| AK-0383/ES | 5 | In distribution | |
| AK-0383/GS | 5 | In distribution | |
| AK-0383/BS | 5 | In distribution | |
| AK-0383/AS | 5 | In distribution | |
| AK-0383/CS | 5 | In distribution | |
| AK-0383/FS | 5 | In distribution | |
| AK-0383/DS | 5 | In distribution | |
| AK-0383/HS | 5 | In distribution |
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 |
| Phaco Accessory Set | Medicel AG | 14 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 11 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 9 |
| 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.