Chisel
3.0mm Ridge Expanding Chisel
5manufacturers in China registered for this device type
10catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), 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 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
Record
| Listed by | Bicon, LLC, United States |
|---|---|
| FDA product code | EML |
| Device type | Chisel, Bone, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-06-10 |
| Record revised | 2020-03-24 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 260-801-330 | In distribution | |
| 260-101-126 | In distribution | |
| 260-901-615 | In distribution | |
| 260-901-613 | In distribution | |
| 260-901-645 | In distribution | |
| 260-901-650 | In distribution | |
| 260-801-355 | In distribution | |
| 260-901-616 | In distribution | |
| 260-801-345 | In distribution | |
| 260-901-660 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 71 |
| Quinelato | Schobell Industrial Ltda | 55 |
| Stoma® | Storz AM Mark Gmbh | 33 |
| devemed | Devemed Gmbh | 30 |
| Zoll-Dental | Zoll-Dental | 29 |
| Power Dental USA | Power Dental U.S.A. Inc. | 24 |
| J & J Instruments | J & J Instruments, LLC | 17 |
| Millennium | Avalign Technologies, Inc. | 16 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 16 |
| Nordent Manufacturing, Inc. | Nordent Manufacturing Inc | 15 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 14 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 14 |
Showing 12 of 50. All products under Chisel, Bone, 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.