Kelman Cystotome
Kelman Cystotom Straight Sharp Edge/TIP
6manufacturers in China registered for this device type
1catalogue number
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 | Sontec Instruments, Inc., United States |
|---|---|
| FDA product code | HMX |
| Device type | Cannula, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2018-09-18 |
| Record revised | 2026-03-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization, Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16-4900 | 22 Gauge Shaft | In distribution |
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.