American Orthopaedic™
AO Cutter Cast 115V AO HEX D
4manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Senolo Medical Technology Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 12 |
| Derma Sciences Nantong Incorporation | Development | Jiangsu | Contract manufacturer | 19 |
| Zhejiang Longyou Landmedical Technology Co., Ltd. | Longyou | Zhejiang | Contract manufacturer | 7 |
| Hangzhou Zhengda Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | BSN Medical, Inc., United States |
|---|---|
| FDA product code | LGH |
| Device type | Instrument, Cast Removal, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 888.5960 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-09-27 |
| Record revised | 2024-04-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 74470-10 | In distribution | |
| 74470-15 | In distribution | |
| 74470-16 | In distribution | |
| 74470-11 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| De Soutter Medical | DE Soutter Medical Ltd. | 108 |
| Instrument, Cast Removal, Ac-Powered | Stryker GmbH | 9 |
| CastVac | Stryker GmbH | 2 |
| Delta-Cast Serene | BSN Medical, Inc. | 2 |
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.