Sterile Cutting Tool
26 catalogue numbers from UBS-RCD130C2-40, listed by Nakanishi Inc., Japan, 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
26catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Nakanishi Inc., Japan |
|---|---|
| FDA product code | HBE |
| Device type | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4310 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K252662 |
| Record published | 2025-11-06 |
| Record revised | 2025-11-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in a place avoiding direct sunlight and high temperatures humidity without any extreme loads. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UBS-RCD130C2-40 | In distribution | |
| UBS-RCD130C2-45 | In distribution | |
| UBS-RD50C1-30 | In distribution | |
| UBS-RCD130C3-30 | In distribution | |
| UBS-RD50C2-15 | In distribution | |
| UBS-RD50C1-20 | In distribution | |
| UBS-RD70C1-20 | In distribution | |
| UBS-RD50C2-10 | In distribution | |
| UBS-RD50C2-06 | In distribution | |
| UBS-RD70C2-10 | In distribution | |
| UBS-RD50C2-07 | In distribution | |
| UBS-RD130C3-30 | In distribution | |
| UBS-RD70C1-30 | In distribution | |
| UBS-RD130C3-45 | In distribution | |
| UBS-RCD130C3-40 | In distribution | |
| UBS-RD130C2-40 | In distribution | |
| UBS-RD50C2-08 | In distribution | |
| UBS-RD70C2-07 | In distribution | |
| UBS-RD70C2-08 | In distribution | |
| UBS-RD130C2-45 | In distribution | |
| UBS-RD130C3-40 | In distribution | |
| UBS-RD130C2-30 | In distribution | |
| UBS-RCD130C3-45 | In distribution | |
| UBS-RD70C2-06 | In distribution | |
| UBS-RCD130C2-30 | In distribution | |
| UBS-RD70C2-15 | 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)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252662 | 2025-09-19 |
| K202120 | 2021-10-22 |
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.