NSK Sterile Blades
24 catalogue numbers from PDS-SO-642, listed by Nakanishi Inc., Japan, under Motor, Drill, Electric. 1 manufacturer in China is registered for this product code.
1manufacturer
24catalogue numbers in this listing
2510(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 | Nakanishi Inc., Japan |
|---|---|
| FDA product code | HBC |
| Device type | Motor, Drill, Electric |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4360 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2016-09-16 |
| Record revised | 2025-12-22 (version 6) |
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 |
| 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 |
|---|---|---|
| PDS-SO-642 | In distribution | |
| PDS-SO-412 | In distribution | |
| PDS-SO-422 | In distribution | |
| PDS-SO-442 | In distribution | |
| PDS-SO-411 | In distribution | |
| PDS-RE-4223 | In distribution | |
| PDS-SO-632 | In distribution | |
| PDS-RE-6127 | In distribution | |
| PDS-RE-4023E | In distribution | |
| PDS-SO-441 | In distribution | |
| PDS-RE-4127 | In distribution | |
| PDS-OSC-432 | In distribution | |
| PDS-OSC-422 | In distribution | |
| PDS-SO-453 | In distribution | |
| PDS-SO-653 | In distribution | |
| PDS-SO-452 | In distribution | |
| PDS-RE-4114 | In distribution | |
| PDS-SO-431 | In distribution | |
| PDS-RE-4023 | In distribution | |
| PDS-RE-4028 | In distribution | |
| PDS-RE-4028E | In distribution | |
| PDS-SO-432 | In distribution | |
| PDS-RE-4217 | In distribution | |
| PDS-SO-433 | 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 |
| 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 |
|---|---|
| K132264 | 2013-12-17 |
| K083112 | 2009-04-29 |
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.