Cytobrush Plus
- Primary DI
- 30888937003193
- Brand
- Cytobrush Plus
- Company
- Coopersurgical, Inc.
- Model
- C0021
- Device description
- Cell collector
- Published
- 2016-09-21
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- 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 |
|---|
| 20888937003196 | Package | GS1 | 1000 | In Commercial Distribution |
| 30888937003193 | Package | GS1 | 10 | In Commercial Distribution |
| 50888937003197 | 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
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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