Rumex
Stodulka Enhanced Irrigation Handpiece For Bimanual Technique, Curved, 21 Ga, Two Ports On Side 0.50 x 1.00 mm, Length 105 mm, Titanium Handle
2manufacturers in China registered for this device type
20catalogue 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 | Rumex International Co., United States |
|---|---|
| FDA product code | KYG |
| Device type | Device, Irrigation, Ocular Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4360 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2020-06-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization, Ethylene Oxide, Moist Heat or Steam Sterilization |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12-001T | In distribution | |
| 7-081 | In distribution | |
| 12-6010 | In distribution | |
| 7-0811 | In distribution | |
| 7-080/90 | In distribution | |
| 7-080/SIM | In distribution | |
| 7-080/BC | In distribution | |
| 12-003T | In distribution | |
| 7-082 | In distribution | |
| 7-0826 | In distribution | |
| 12-6000 | In distribution | |
| 7-080/ST | In distribution | |
| 7-0821 | In distribution | |
| 7-081-23 | In distribution | |
| 7-080/20 | In distribution | |
| 7-080/IAH | In distribution | |
| 7-0813 | In distribution | |
| 7-080/45 | In distribution | |
| 13-139/I | In distribution | |
| 7-0821-23 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 137 |
| 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 |
| 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.