Swiss Bi-Manual I/A
29 catalogue numbers from SBS105, listed by Medicel AG, Switzerland, under Cannula, Ophthalmic. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
29catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
| Huaian Frimen Co., Ltd. | Huaian | Jiangsu | Manufacturer | 16 |
Record
| Listed by | Medicel AG, Switzerland |
|---|---|
| FDA product code | HMX |
| Device type | Cannula, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-12-01 |
| Record revised | 2023-12-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2023-12-05 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SBS105 | In distribution | ||
| SBS110A | In distribution | ||
| SBS320A | In distribution | ||
| SBS123A | In distribution | ||
| SBS310A | In distribution | ||
| SBS123A | 10 | Withdrawn | |
| SBS105RU | 10 | Withdrawn | |
| SBI120A | Withdrawn | ||
| SBI121B | Withdrawn | ||
| SBI126B | Withdrawn | ||
| SBS105 | 10 | Withdrawn | |
| SBS320 | 10 | Withdrawn | |
| SBA105A | Withdrawn | ||
| SBS310A | 10 | Withdrawn | |
| SBA100A | Withdrawn | ||
| SBA104A | Withdrawn | ||
| SBS122A | 10 | Withdrawn | |
| SBS320A | 10 | Withdrawn | |
| SBA110 | Withdrawn | ||
| SBS122A | Withdrawn | ||
| SBA101B | Withdrawn | ||
| SBI125A | Withdrawn | ||
| SBA103A | Withdrawn | ||
| SBS110ARU | 10 | Withdrawn | |
| SBS320 | Withdrawn | ||
| SBS310 | 10 | Withdrawn | |
| SBS110A | 10 | Withdrawn | |
| SBI130 | Withdrawn | ||
| SBA106B | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Anodyne Surgical | Psi/Eye-Ko, Inc. | 909 |
| Walcott Rx Products | Walcott Rx Product Inc | 663 |
| MR Phaco | Crestpoint Management Ltd. | 625 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 511 |
| Ambler Surgical | Ambler Surgical, LLC | 447 |
| Millennium | Avalign Technologies, Inc. | 270 |
| Ophthalmic Cannula | Katena Products, Inc. | 251 |
| Surgistar | Surgistar, Inc. | 179 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 137 |
| Walcott Rx Products | Psi/Eye-Ko, Inc. | 133 |
| Surgical Direct | Surgical Direct, Inc. | 127 |
| Visitec® | Beaver-Visitec International, Ltd | 124 |
Showing 12 of 1,064. All products under Cannula, Ophthalmic
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.