Sklar®
D.E. Columbia Curette 13 & 14
4manufacturers in China registered for this device type
40catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), 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 Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | EMK |
| Device type | Curette, Surgical, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-12-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 49-2660 | In distribution | |
| 41-824 | In distribution | |
| 49-2605 | In distribution | |
| 49-2665 | In distribution | |
| 49-3300 | In distribution | |
| 49-2650 | In distribution | |
| 49-2635 | In distribution | |
| 49-3345 | In distribution | |
| 41-832 | In distribution | |
| 41-808 | In distribution | |
| 49-3340 | In distribution | |
| 49-2670 | In distribution | |
| 49-3335 | In distribution | |
| 49-3355 | In distribution | |
| 41-828 | In distribution | |
| 49-2600 | In distribution | |
| 41-812 | In distribution | |
| 41-856 | In distribution | |
| 49-3305 | In distribution | |
| 49-2675 | In distribution | |
| 41-864 | In distribution | |
| 49-3350 | In distribution | |
| 41-820 | In distribution | |
| 49-2645 | In distribution | |
| 41-852 | In distribution | |
| 49-2610 | In distribution | |
| 49-3315 | In distribution | |
| 41-878 | In distribution | |
| 41-848 | In distribution | |
| 49-2655 | In distribution | |
| 49-2615 | In distribution | |
| 41-875 | In distribution | |
| 41-800 | In distribution | |
| 49-2625 | In distribution | |
| 49-2620 | In distribution | |
| 41-870 | In distribution | |
| 49-3330 | In distribution | |
| 49-2630 | In distribution | |
| 49-3310 | In distribution | |
| 49-2640 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 693 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 170 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 112 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 85 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 72 |
| Paul Banditt | Terlain Enterprises, Inc. | 52 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 45 |
| Anatomic Colours | Aesculap AG | 39 |
| Zoll-Dental | Zoll-Dental | 39 |
| Aesculap | Aesculap AG | 39 |
| devemed | Devemed Gmbh | 33 |
| Reicodent | Devemed Gmbh | 30 |
Showing 12 of 107. All products under Curette, 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.