Avalign
Knife Handle #4L OL 210(8 1/4")
29manufacturers in China registered for this device type
14catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (9), Shanghai (9), Zhejiang (3). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Xiantao Sanda Industrial Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 10 |
| Ningbo Medsun Medical Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
Showing 12 of 29. All 29 manufacturers in China registered for Handle, Scalpel
Record
| Listed by | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | GDZ |
| Device type | Handle, Scalpel |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-28 |
| Record revised | 2023-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VM107-6606 | In distribution | |
| VM21-1118X | In distribution | |
| VM21-1134 | In distribution | |
| VM21-1142 | In distribution | |
| VM21-1118 | In distribution | |
| VM21-1141 | In distribution | |
| VM21-1114 | In distribution | |
| VM21113421 | In distribution | |
| VM21-1115 | In distribution | |
| VM21-1131 | In distribution | |
| VM21-1129 | In distribution | |
| VM21-1132 | In distribution | |
| VM21-1151 | In distribution | |
| VM21-1110 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| comknife® | Beijing Bohai Kangyuan Medical Devices Co., Ltd. | 298 |
| Surgical Direct | Surgical Direct, Inc. | 68 |
| Millennium | Avalign Technologies, Inc. | 46 |
| Aesculap | Aesculap AG | 41 |
| Ambler Surgical | Ambler Surgical, LLC | 39 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 37 |
| DeRoyal | Deroyal Industries, Inc. | 34 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 31 |
| V. Mueller | Steris Corporation | 31 |
| gSource | Gsource, LLC. | 29 |
| Handle | KLS-Martin L.P. | 28 |
| Sklar® | Sklar Corporation | 28 |
Showing 12 of 226. All products under Handle, Scalpel
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.