Brasseler USA
166RF.21.021 Lindeman Steel 1P
5manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Guangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Shanghai Fanta Dental Materials Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Changzhou Bomedent Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
Record
| Listed by | Peter Brasseler Holdings, LLC |
|---|---|
| FDA product code | EKD |
| Device type | Instrument, Cutting, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2022-12-07 |
| Record revised | 2023-08-10 (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, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 003859U0 | In distribution | |
| 002323U0 | In distribution | |
| 003993U1 | In distribution | |
| 002325U0 | In distribution | |
| 003083U0 | In distribution | |
| 5007773U1 | In distribution | |
| 5023635U0 | In distribution | |
| 003755U0 | In distribution | |
| 003087U0 | In distribution | |
| 002468U0 | In distribution | |
| 002327U0 | In distribution | |
| 003993U0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 365 |
| Blue AND Green | Nordent Manufacturing Inc | 43 |
| devemed | Devemed Gmbh | 31 |
| Reicodent | Devemed Gmbh | 29 |
| Instrument, Cutting, Operative | Jota AG | 15 |
| Burkhart Dental | Nordent Manufacturing Inc | 11 |
| National Distribution & Contracting Inc. | Nordent Manufacturing Inc | 11 |
| J&J Instruments | J & J Instruments, LLC | 10 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 9 |
| Zoll-Dental | Zoll-Dental | 9 |
| Henry Schein | Henry Schein, Inc. | 9 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 8 |
Showing 12 of 36. All products under Instrument, Cutting, Operative
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.