Midas Rex MR8
Tubing IRD850 MR8 Irrigation ON-Drill EA
1manufacturer
7catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Rainbow Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 12 |
Record
| Listed by | Medtronic Powered Surgical Solutions, United States |
|---|---|
| FDA product code | HBC |
| Device type | Motor, Drill, Electric |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4360 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K183515 |
| Record published | 2019-06-08 |
| Record revised | 2024-09-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| EM800 | In distribution | ||
| IRD850 | In distribution | ||
| EM800 | In distribution | ||
| IRD870 | In distribution | ||
| MR8-DS1TD75 | In distribution | ||
| IRD875 | 5 | In distribution | |
| EM810 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NSK Sterile Burs/Drills | Nakanishi Inc. | 447 |
| Motor, Drill, Electric | Anspach Effort, The | 168 |
| Primado2 | Nakanishi Inc. | 96 |
| Elan 4 | Aesculap AG | 39 |
| Midas REX® | Medtronic Powered Surgical Solutions | 29 |
| NSK Sterile Blades | Nakanishi Inc. | 24 |
| Motor, Drill, Electric | Synthes Gmbh | 22 |
| Aesculap | Aesculap AG | 14 |
| SSG10 | Saeshin Precision Co., Ltd. | 11 |
| Traus | Saeshin Precision Co., Ltd. | 9 |
| Eccos | Aesculap AG | 7 |
| Motor, Drill, Electric | Medtronic Xomed, Inc. | 6 |
Showing 12 of 75. All products under Motor, Drill, Electric
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K183515 | 2019-05-12 |
| K170312 | 2017-05-15 |
| K163565 | 2017-03-28 |
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.