Karl Schumacher
Ang Cncve Osteotome, 2.6-3.2mm,Slvr/Yell
4manufacturers in China registered for this device type
26catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), 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 |
| Pengbo (Shenzhen) Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | Karl Schumacher Dental, LLC, United States |
|---|---|
| FDA product code | EMM |
| Device type | Chisel, Osteotome, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2024-03-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IDR0010 | In distribution | |
| BSS0995 | In distribution | |
| BWW0931 | In distribution | |
| BCH0913 | In distribution | |
| 47.945.33 | In distribution | |
| 47.945.20 | In distribution | |
| 47.943.33 | In distribution | |
| BWW0933 | In distribution | |
| IDR0008 | In distribution | |
| IDR0006G | In distribution | |
| 47.945.28 | In distribution | |
| 47.943.38 | In distribution | |
| BWW0932 | In distribution | |
| BCH0911 | In distribution | |
| BWW0934 | In distribution | |
| IDR0006 | In distribution | |
| 47.945.38 | In distribution | |
| BCH0912 | In distribution | |
| IDR0008G | In distribution | |
| 47.943.20 | In distribution | |
| 47.943.43 | In distribution | |
| FEDI2 | In distribution | |
| IDR0010G | In distribution | |
| IDR0090 | In distribution | |
| 47.945.43 | In distribution | |
| 47.943.28 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 482 |
| gSource | Gsource, LLC. | 296 |
| Tatum Surgical-Osteotome | Suncoast Dental, Inc. | 108 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 101 |
| Kohdent | Kohler Medizintechnik GmbH | 86 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 78 |
| ACE | Ace Surgical Supply Co., Inc. | 73 |
| Osteotome | KLS-Martin L.P. | 70 |
| Aesculap | Aesculap AG | 69 |
| Salvin Dental Specialties | Salvin Dental Specialties, LLC | 64 |
| Millennium | Avalign Technologies, Inc. | 63 |
| devemed | Devemed Gmbh | 63 |
Showing 12 of 283. All products under Chisel, Osteotome, Surgical
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.