Premier Rongeur
Rongeur 1A
6manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
Record
| Listed by | Premier Dental Products Co., United States |
|---|---|
| FDA product code | EGN |
| Device type | Scissors, Surgical Tissue, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-04-10 |
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 |
|---|---|---|
| 9065073 | In distribution | |
| 9065071 | In distribution | |
| 9065076 | In distribution | |
| 9065070 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 1,038 |
| Scissors, Surgical Tissue, Dental | George Tiemann & Co. | 386 |
| Melpex | Melpex Beauty Instruments | 179 |
| Zoll-Dental | Zoll-Dental | 109 |
| J & J Instruments | J & J Instruments, LLC | 105 |
| Stoma® | Storz AM Mark Gmbh | 67 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 66 |
| ACE | Ace Surgical Supply Co., Inc. | 66 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 63 |
| Kohdent | Kohler Medizintechnik GmbH | 62 |
| Pomee | Pomee Corporation | 57 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 41 |
Showing 12 of 194. All products under Scissors, Surgical Tissue, Dental
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.