Single Use Brush Biopsy Instrument
WATS Biopsy Instrument for Computer Assisted 3D Analysis
8manufacturers in China registered for this device type
5catalogue 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 | Endo-Therapeutics, Inc., 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, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep Dry |
| Sizes | Length 80 to 230 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TNL-80 | Length 80 cm | In distribution |
| TNE-110 | Length 110 cm | In distribution |
| EGD-160-006 | Sheath Diameter 2.6 mm | In distribution |
| WGB-200-006 | Sheath Diameter 3.0 mm | In distribution |
| EGD-230-006 | Length 230 cm | 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 |
| 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.