Brasseler USA
K0313 Hybrid Elevator System 1P
6manufacturers in China registered for this device type
56catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Changsha Nice Medical Instrument Limited Company | Changsha | Hunan | Manufacturer | 17 |
Record
| Listed by | Peter Brasseler Holdings, LLC |
|---|---|
| FDA product code | EMJ |
| Device type | Elevator, Surgical, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
| Record revised | 2024-04-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5023178U0 | In distribution | |
| 5025493U0 | In distribution | |
| 5023507U0 | In distribution | |
| 5023521U0 | In distribution | |
| 5024208U0 | In distribution | |
| 5023493U0 | In distribution | |
| 5023501U0 | In distribution | |
| 5023526U0 | In distribution | |
| 5023529U0 | In distribution | |
| 5023505U0 | In distribution | |
| 5023513U0 | In distribution | |
| 5023506U0 | In distribution | |
| 5023511U0 | In distribution | |
| 5023496U0 | In distribution | |
| 5025509U0 | In distribution | |
| 5023176U0 | In distribution | |
| 5023516U0 | In distribution | |
| 5023495U0 | In distribution | |
| 5023504U0 | In distribution | |
| 5023525U0 | In distribution | |
| 5023499U0 | In distribution | |
| 5023492U0 | In distribution | |
| 5023517U0 | In distribution | |
| 5023498U0 | In distribution | |
| 5024205U0 | In distribution | |
| 5023177U0 | In distribution | |
| 5023174U0 | In distribution | |
| 5023175U0 | In distribution | |
| 5023515U0 | In distribution | |
| 5024207U0 | In distribution | |
| 5023502U0 | In distribution | |
| 5023173U0 | In distribution | |
| 5023514U0 | In distribution | |
| 5023512U0 | In distribution | |
| 5023509U0 | In distribution | |
| 5025495U0 | In distribution | |
| 5023522U0 | In distribution | |
| 5023494U0 | In distribution | |
| 5023520U0 | In distribution | |
| 5023503U0 | In distribution | |
| 5025492U0 | In distribution | |
| 5023518U0 | In distribution | |
| 5023500U0 | In distribution | |
| 5023519U0 | In distribution | |
| 5023527U0 | In distribution | |
| 5023508U0 | In distribution | |
| 5023530U0 | In distribution | |
| 5023510U0 | In distribution | |
| 5023497U0 | In distribution | |
| 5023179U0 | In distribution | |
| 5023524U0 | In distribution | |
| 5023528U0 | In distribution | |
| 5025491U0 | In distribution | |
| 5024206U0 | In distribution | |
| 5023491U0 | In distribution | |
| 5025494U0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 465 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 264 |
| Power Dental USA | Power Dental U.S.A. Inc. | 247 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 233 |
| Elevator | KLS-Martin L.P. | 231 |
| Kohdent | Kohler Medizintechnik GmbH | 206 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 153 |
| Stoma® | Storz AM Mark Gmbh | 150 |
| Reicodent | Devemed Gmbh | 142 |
| Sklar | Sklar Corporation | 130 |
| Osung MND | Osung MND Co., Ltd. | 126 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 121 |
Showing 12 of 743. All products under Elevator, Surgical, Dental
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.