NSK Sterile Rasps/Files
4 catalogue numbers from PDS-RE-R111, listed by Nakanishi Inc., Japan, under Motor, Drill, Electric. 1 manufacturer in China is registered for this product code.
1manufacturer
4catalogue 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 | 2026-04-09 (version 8) |
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 |
|---|---|---|
| PDS-RE-R111 | In distribution | |
| PDS-RE-R012 | In distribution | |
| PDS-RE-R011 | In distribution | |
| PDS-RE-R112 | 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 |
| Midas Rex MR8 | Medtronic Powered Surgical Solutions | 7 |
| Eccos | Aesculap AG | 7 |
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.