Rovers® Cervex-Brush® Combi
The Cervex-Brush® Combi is a single-use cell sampler intended to collect simultaneous cell material from the ectocervical, endocervical and transformation-zone in women.
3manufacturers in China registered for this device type
8catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Rovers Medical Devices B.V., Netherlands |
|---|---|
| FDA product code | HHT |
| Device type | Spatula, Cervical, Cytological |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Manufacturer |
| 510(k) | K043369 |
| Record published | 2018-07-16 |
| Record revised | 2023-07-13 (version 4) |
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, manufacturing date |
| Packaging | Pack of 20, pack of 6, box of 20, exportbox of 176, export box of 176 |
| Distribution end date | 2018-08-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 380101000 | 25 | In distribution | |
| 380102031 | 100 | In distribution | |
| 380101-030 | 25 | In distribution | |
| 380101031 | 100 | In distribution | |
| 380301031 | 100 | In distribution | |
| 491462 | 25 | In distribution | |
| 380101031 | 100 | Withdrawn | |
| 380101000 | 25 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rovers® Cervex-Brush® | Rovers Medical Devices B.V. | 10 |
| Andwin Scientific | Andwin Scientific | 9 |
| 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 |
| C21150 | B & B Medical Technologies, Inc. | 4 |
Showing 12 of 49. All products under Spatula, Cervical, Cytological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K043369 | 2005-02-02 |
| K002520 | 2000-11-13 |
| K001119 | 2000-05-19 |
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.