Rovers® Orcellex® Brush RT
Oral cell sampler, sterile
8manufacturers in China registered for this device type
1catalogue number
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 | Rovers Medical Devices B.V., Netherlands |
|---|---|
| FDA product code | GEE |
| Device type | Brush, Biopsy, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-10-22 |
| Record revised | 2023-07-13 (version 3) |
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 |
| Packaging | Pack of 20, pack of 6 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 380380331 | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 18 |
| Conmed | ConMed Corporation | 6 |
| Midas Rex | Medtronic Powered Surgical Solutions | 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 |
| 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.