Gsource
Nylon/Steel brush 7" with plastic handle, double headed
8manufacturers in China registered for this device type
3catalogue 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 | Gsource, LLC., United States |
|---|---|
| FDA product code | GEE |
| Device type | Brush, Biopsy, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-25 |
| Record revised | 2020-11-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| gS 99.0100 | In distribution | |
| gS 99.0104 | In distribution | |
| gS 99.0102 | 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 |
| 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.