Universal Kit
2 catalogue numbers from UNII3000, listed by Megagen Implant Co., Ltd., South Korea, under Elevator, Surgical, Dental. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| 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 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Changsha Nice Medical Instrument Limited Company | Changsha | Hunan | Manufacturer | 17 |
Record
| Listed by | Megagen Implant Co., Ltd., South Korea |
|---|---|
| FDA product code | EMJ |
| Device type | Elevator, Surgical, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-06-27 |
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, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UNII3000 | In distribution | |
| UNI3000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 465 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 264 |
| Power Dental USA | Power Dental U.S.A. Inc. | 247 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 233 |
| Elevator | KLS-Martin L.P. | 231 |
| Kohdent | Kohler Medizintechnik GmbH | 206 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 153 |
| Stoma® | Storz AM Mark Gmbh | 150 |
| Reicodent | Devemed Gmbh | 142 |
| Sklar | Sklar Corporation | 130 |
| Osung MND | Osung MND Co., Ltd. | 126 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 121 |
Showing 12 of 743. All products under Elevator, Surgical, 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.