File, Bone, Surgical
10 catalogue numbers from 09-0214, listed by Biomet Microfixation, United States, under File, Bone, Surgical. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
10catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Shandong (1), Beijing (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 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
| Univy Technology Advanced Co., Ltd. | Shanghai | Shanghai | Manufacturer | 8 |
Record
| Listed by | Biomet Microfixation, United States |
|---|---|
| FDA product code | EMI |
| Device type | File, 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 | 2018-08-22 |
| Record revised | 2025-05-30 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 09-0214 | In distribution | |
| 09-0217 | In distribution | |
| 51-1600 | In distribution | |
| 09-0229 | In distribution | |
| 09-0221 | In distribution | |
| 09-0215 | In distribution | |
| 51-1610 | In distribution | |
| 09-0222 | In distribution | |
| 09-0201 | In distribution | |
| 09-0212 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DentaSonic | GC Orthodontics America Inc. | 37 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 24 |
| Reicodent | Devemed Gmbh | 22 |
| Zoll-Dental | Zoll-Dental | 21 |
| File | KLS-Martin L.P. | 20 |
| devemed | Devemed Gmbh | 18 |
| Sklar® | Sklar Corporation | 16 |
| Ambler Surgical | Ambler Surgical, LLC | 10 |
| Quinelato | Schobell Industrial Ltda | 9 |
| V. Mueller | Steris Corporation | 9 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 7 |
| gSource | Gsource, LLC. | 7 |
Showing 12 of 66. All products under File, 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.