HS-Handpiece,angled,70mm,80k
2 catalogue numbers from 362680, listed by Bien-AIR Surgery SA, Switzerland, under Drills, Burrs, Trephines & Accessories (Simple, Powered). 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Bien-AIR Surgery SA, Switzerland |
|---|---|
| FDA product code | HBE |
| Device type | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4310 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
| Record published | 2023-02-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 362680 | In distribution | |
| 362681 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midas REX MR8 | Medtronic Powered Surgical Solutions | 1,006 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Stryker GmbH | 948 |
| Elan 4 | Aesculap AG | 529 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Synthes Gmbh | 514 |
| Zethon | Zethon Ltd | 237 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Stryker Leibinger Gmbh & Co. KG | 220 |
| Midas Rex® | Medtronic Powered Surgical Solutions | 167 |
| HiCUT Burs | Adeor Medical AG | 90 |
| Phasor | Phasor Health, LLC | 80 |
| Traumaone System | Biomet Microfixation | 62 |
| Midas REX Microsaws | Medtronic Powered Surgical Solutions | 60 |
| Mids REX MR8 | Medtronic Powered Surgical Solutions | 59 |
Showing 12 of 269. All products under Drills, Burrs, Trephines & Accessories (Simple, Powered)
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.