Midas REX®
Accy EF105-R Legend EHS Foot Cont Refurb
1manufacturer
29catalogue 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) | K170312 |
| Record published | 2018-05-31 |
| Record revised | 2022-09-16 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment temperature -40 to 158 °F; Storage environment temperature -40 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BM110-R | In distribution | |
| EF100 | In distribution | |
| EM100-A-R | In distribution | |
| EA520 | In distribution | |
| EM200 | In distribution | |
| EF105-R | In distribution | |
| EM100-A | In distribution | |
| EA110 | In distribution | |
| EM200 | In distribution | |
| BM120 | In distribution | |
| EM200-R | In distribution | |
| EA600-R | In distribution | |
| EA300 | In distribution | |
| EF105 | In distribution | |
| EM100-A-R | In distribution | |
| EM200-R | In distribution | |
| BM110 | In distribution | |
| EM100 | In distribution | |
| BM120 | In distribution | |
| EF100-R | In distribution | |
| EM200 | In distribution | |
| BM120-R | In distribution | |
| BM120-R | In distribution | |
| EM200-R | In distribution | |
| EA200 | In distribution | |
| EM100-A | In distribution | |
| EM100 | In distribution | |
| EA600 | In distribution | |
| EA110 | 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 |
| 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 |
| Midas Rex MR8 | Medtronic Powered Surgical Solutions | 7 |
| 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.