Instrument, Cutting, Operative
15 catalogue numbers from C31R.FG.012, listed by Jota AG, Switzerland, under Instrument, Cutting, Operative. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
15catalogue 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 | Jota AG, Switzerland |
|---|---|
| FDA product code | EKD |
| Device type | Instrument, Cutting, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-09-15 |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| C31R.FG.012 | 5 | In distribution | |
| AIID TIT ABU ADJ KIT 1825 | 8 | In distribution | |
| C379.FG.023 | 5 | In distribution | |
| UNC245.FG.009 | 5 | In distribution | |
| C33IL.FGXL.010 | 2 | In distribution | |
| C246.FG.009 | 5 | In distribution | |
| C21.FG.008 | 5 | In distribution | |
| CX23R.FG.012 | 5 | In distribution | |
| CBP379.FG.023 | 5 | In distribution | |
| CBP856.FG.016 | 5 | In distribution | |
| C21.FG.014 | 5 | In distribution | |
| RRC31R.FG.012 | 5 | In distribution | |
| CBP847.FG.016 | 5 | In distribution | |
| CX21R.FG.012 | 5 | In distribution | |
| RRC31.FG.010 | 5 | 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 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 12 |
| 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.