Instrapac
Instrapac Warwick-James Elevator Set - Left, Right & Straight x 10
6manufacturers in China registered for this device type
17catalogue 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 | Robinson Healthcare Limited, United Kingdom |
|---|---|
| FDA product code | EMJ |
| Device type | Elevator, Surgical, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-08-08 |
| Record revised | 2026-02-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep dry and keep out of direct sunlight |
| Packaging | Box of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7394 | 3mm Straight | In distribution |
| 8125 | In distribution | |
| 8128 | In distribution | |
| 8126 | In distribution | |
| 7395 | 3mm curved | In distribution |
| 8131 | In distribution | |
| 8469 | 3S (3mm Straight) | In distribution |
| 8123 | In distribution | |
| 8127 | In distribution | |
| 8129 | In distribution | |
| 8471 | 5S (5mm Straight) | In distribution |
| 8472 | 5C (5mm Curved) | In distribution |
| 8133 | In distribution | |
| 8130 | In distribution | |
| 8124 | In distribution | |
| 8132 | In distribution | |
| 8470 | 3C (3mm Curved) | 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.