HU-Friedy
#31/32 Rhein DE Amalgam File, #7 Color
1manufacturer
5catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | HU-Friedy MFG Co., LLC, United States |
|---|---|
| FDA product code | EKA |
| Device type | File, Margin Finishing, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-11-12 |
| Record revised | 2024-10-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Distribution end date | 2024-05-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AF5160 | In distribution | |
| 3N0181 | In distribution | |
| AF1/4 | In distribution | |
| AF31/32 | In distribution | |
| AF2/5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Zoll-Dental | Zoll-Dental | 7 |
| Osung MND | Osung MND Co., Ltd. | 5 |
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.