Brasseler USA
SM13/14S4 Mccall 13S/14S #4 HDL
3manufacturers in China registered for this device type
108catalogue 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 |
Record
| Listed by | Peter Brasseler Holdings, LLC |
|---|---|
| FDA product code | EMS |
| Device type | Curette, Periodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
| 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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5023427U0 | In distribution | |
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| 5023353U0 | In distribution | |
| 5023430U0 | In distribution | |
| 5023318U0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 1,276 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 1,032 |
| American Eagle Instruments | American Eagle Instruments | 681 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 301 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 185 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 145 |
| Stoma® | Storz AM Mark Gmbh | 121 |
| PDT, Inc. | PDT, Inc. | 120 |
| Henry Schein | Henry Schein, Inc. | 112 |
| Pomee | Pomee Corporation | 69 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 63 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 62 |
Showing 12 of 321. All products under Curette, Periodontic
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.