Cytobrush Plus
- Primary DI
- 30888937003278
- Brand
- Cytobrush Plus
- Company
- Coopersurgical, Inc.
- Model
- C0012
- Device description
- Cell collector
- Published
- 2016-08-25
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| HHT | Spatula, Cervical, Cytological |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HHT | Spatula, Cervical, Cytological | Obstetrics/Gynecology | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K832986 | 000 | PAP SMEAR BRUSH | Donald G. Zeller | 1984-02-10 | HHT |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 20888937003271 | Package | GS1 | 40 | In Commercial Distribution |
| 30888937003278 | Package | GS1 | 2000 | In Commercial Distribution |
| 00888937003277 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Cervical cytology brush | A device with bristle-like projections designed to obtain a cervical biopsy of a suspicious area or visible exocervical lesions detected during a vaginal examination for the purpose of obtaining a tissue diagnosis from a woman with intraepithelial disease. It is inserted into the vagina and the head of the brush is firmly rotated over the area of interest until is covered with a bloody-mucoid sample. Some types may also have small bristles on a central protrusion that simultaneously enters the endocervical canal. The sample is secured in a cytology fixation solution or smeared onto a microscope slide for a Papanicolaou test (PAP). This is a single-use device. |
Regulatory Flags
- DUNS number
- 801895244
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00860011506300 | CytoSoft | Medical Packaging Corporation | HHT | 2026-02-18 |
| 00860011506324 | CytoSoft | Medical Packaging Corporation | HHT | 2026-02-18 |
| 00860011506331 | CYTO-PAK | Medical Packaging Corporation | HHT | 2026-02-18 |
| 07898027908460 | KOLPLAST | Kolplast C I | HHT | 2023-11-29 |
| 08809157488011 | C20310 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488028 | C20310 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488035 | C20310 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488042 | C20310 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488110 | C21150 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488127 | C21150 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488134 | C21150 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488141 | C21150 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488219 | C27024 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488226 | C27024 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488233 | C27024 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488240 | C27024 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488318 | C27632 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488325 | C27632 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488332 | C27632 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488349 | C27632 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488417 | C29000 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488424 | C29000 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488431 | C29000 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488448 | C29000 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488516 | C60100 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488523 | C60100 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488530 | C60100 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08809157488547 | C60100 | B&B Company Co.,Ltd. | HHT | 2023-07-17 |
| 08719189246445 | Rovers® Evalyn® Brush | Rovers Medical Devices B.V. | HHT | 2023-07-12 |
| 28719189246081 | Rovers® Cervex-Brush® Combi | Rovers Medical Devices B.V. | HHT | 2023-07-12 |