Primado2
96 catalogue numbers from P200-REC-S-HS, listed by Nakanishi Inc., Japan, under Motor, Drill, Electric. 1 manufacturer in China is registered for this product code.
1manufacturer
96catalogue 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 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-07-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P200-REC-S-HS | In distribution | |
| P200-2AES | In distribution | |
| P200-OSC | In distribution | |
| P200-WPD | In distribution | |
| P200-HMH-HS | In distribution | |
| P200-RCRD-L | In distribution | |
| PD-DA-A | In distribution | |
| P200-SAG | In distribution | |
| P200-BMH-HS | In distribution | |
| P200-3GAM | In distribution | |
| P200-RA330 | In distribution | |
| P200-RCRD-M | In distribution | |
| PD-RA-H | In distribution | |
| P200-SAG-S-HS | In distribution | |
| P200-2SES | In distribution | |
| P200-SMH-G | In distribution | |
| P200-CU-120 | In distribution | |
| P200-2SL | In distribution | |
| PD-DA-K | In distribution | |
| P200-3MC | In distribution | |
| FC-74 | In distribution | |
| PD-RA-T | In distribution | |
| P200-2SS | In distribution | |
| P200-OSC-S | In distribution | |
| PD-SA-R | In distribution | |
| P200-REC-S | In distribution | |
| P200-CRD-L | In distribution | |
| P200-PER | In distribution | |
| P200-1A175 | In distribution | |
| PD-DA-W | In distribution | |
| PD-DA-J4 | In distribution | |
| P200-BMH | In distribution | |
| P200-HMH | In distribution | |
| P200-1A135 | In distribution | |
| P200-RCRD-P | In distribution | |
| P200-CA-4 | In distribution | |
| P200-2SD | In distribution | |
| P200-CRD-P | In distribution | |
| P200-SMH-S | In distribution | |
| P200-CRA | In distribution | |
| P200-2AS | In distribution | |
| P200-SMH-HS | In distribution | |
| P200-CRD-M | In distribution | |
| PD-DA-P | In distribution | |
| P200-2AM | In distribution | |
| P200-2SMS | In distribution | |
| P200-REC | In distribution | |
| P200-2S225-G | In distribution | |
| P200-2SM | In distribution | |
| P200-2AMS | In distribution | |
| P200-CU-230 | In distribution | |
| P200-RA330-L | In distribution | |
| P200-2AL | In distribution | |
| PD-SA-S | In distribution | |
| P200-2A110-G | In distribution | |
| P200-2S110-G | In distribution | |
| PD-RA-A | In distribution | |
| P200-SMH | In distribution | |
| P200-1A155-C | In distribution | |
| P200-SAG-S | In distribution | |
| P200-3GAL | In distribution | |
| P200-1A175-C | In distribution | |
| P200-1A155 | In distribution | |
| PD-DA-J6 | In distribution | |
| FC-73 | In distribution | |
| PD-2SD | In distribution | |
| P200-OSC-S-HS | In distribution | |
| PD-RA-M | In distribution | |
| P200-3GAS | In distribution | |
| PD-RA155 | Withdrawn | |
| P200-CRA | Withdrawn | |
| PD-CA-16 | Withdrawn | |
| PD-CRD-M | Withdrawn | |
| PD-1A155-10 | Withdrawn | |
| PD-CA-64 | Withdrawn | |
| PD-2SDM | Withdrawn | |
| PD-1A135 | Withdrawn | |
| P200-RA155 | Withdrawn | |
| PD-2AL | Withdrawn | |
| PD-RA135 | Withdrawn | |
| PD-RA330-L | Withdrawn | |
| PD-2SES | Withdrawn | |
| PD-2ADM | Withdrawn | |
| PD-2SM | Withdrawn | |
| PD-1A175-10 | Withdrawn | |
| PD-RA330 | Withdrawn | |
| PD-CRD-P | Withdrawn | |
| PD-CRD-L | Withdrawn | |
| PD-CRA | Withdrawn | |
| PD-2AES | Withdrawn | |
| PD-2AD | Withdrawn | |
| PD-2SS | Withdrawn | |
| PD-2AM | Withdrawn | |
| PD-PER | Withdrawn | |
| PD-2AS | Withdrawn | |
| P200-RA135 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NSK Sterile Burs/Drills | Nakanishi Inc. | 447 |
| Motor, Drill, Electric | Anspach Effort, The | 168 |
| 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 |
| 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.