BD Surepath Sample Collection Kit
Cervical cytology sampling kit
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Suyun Medical Materials Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 11 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
| Ningbo HLS Medical Products Co., Ltd. | Cixi | Zhejiang | Manufacturer | 7 |
Record
| Listed by | Coopersurgical, Inc., United States |
|---|---|
| FDA product code | HHT |
| Device type | Spatula, Cervical, Cytological |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K861389 |
| Record published | 2018-09-21 |
| Record revised | 2024-02-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 490525 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rovers® Cervex-Brush® | Rovers Medical Devices B.V. | 10 |
| Andwin Scientific | Andwin Scientific | 9 |
| Rovers® Cervex-Brush® Combi | Rovers Medical Devices B.V. | 8 |
| Medscand Pap-Perfect Supply Tray | Coopersurgical, Inc. | 6 |
| Papette | Coopersurgical, Inc. | 6 |
| C20310 | B & B Medical Technologies, Inc. | 4 |
| C27024 | B & B Medical Technologies, Inc. | 4 |
| Cytobrush Plus GT | Coopersurgical, Inc. | 4 |
| Rovers® EndoCervex-Brush® | Rovers Medical Devices B.V. | 4 |
| C29000 | B & B Medical Technologies, Inc. | 4 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 4 |
| Cytobrush Plus | Coopersurgical, Inc. | 4 |
Showing 12 of 49. All products under Spatula, Cervical, Cytological
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.