Midas Rex
Accy PA315 Midas REX MED Clening Brsh PK
8manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2), Guangdong (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Goodwood Medical Care Ltd | Dalian | Liaoning | Contract manufacturer | 19 |
| Yancheng Huida Medical Instruments Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 10 |
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
| Ningbo Yingmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 29 |
| Jiangsu Suyun Medical Materials Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 11 |
| Guangzhou Aoqun New Materials Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 6 |
Record
| Listed by | Medtronic Powered Surgical Solutions, United States |
|---|---|
| FDA product code | GEE |
| Device type | Brush, Biopsy, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K020069 |
| Record published | 2020-10-02 |
| Record revised | 2022-06-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PA315 | 5 | In distribution | |
| PA305 | 5 | In distribution | |
| PA325 | 5 | In distribution | |
| PA305 | 5 | In distribution | |
| PA325 | 5 | In distribution | |
| PA315 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 18 |
| Conmed | ConMed Corporation | 6 |
| Single Use Brush Biopsy Instrument | Endo-Therapeutics, Inc. | 5 |
| gSource | Gsource, LLC. | 3 |
| Swab-PAK | Medical Packaging Corporation | 2 |
| Hobbs Nasal Cytology Brush | Hobbs Medical, Inc. | 2 |
| Brush, Biopsy, General & Plastic Surgery | ConMed Corporation | 2 |
| Harrell | ConMed Corporation | 2 |
| StatLab | Yancheng Huida Medical Instruments Co., Ltd. | 2 |
| Rovers® Orcellex® Brush RT | Rovers Medical Devices B.V. | 1 |
| Biopsy Brush | Endo-Therapeutics, Inc. | 1 |
| SBH | SBH Surgical | 1 |
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.