Identity
- Trade Name
- Rovers® Viba-Brush® FDA UDI
- Generic Name
- Cytology scraper, single-use FDA UDI
- Device Name
- The Viba-Brush® is a single use cell-sampling device that allows easy, painless, safe and effective collection of cell material from the vagina. FDA UDI
- Model / Reference
- 380320331 FDA UDI
- Description
- The Viba-Brush® is a single use cell-sampling device that allows easy, painless, safe and effective collection of cell material from the vagina. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18719189246251 FDA UDI
- 510(k) Number
- K933870 FDA UDI
- FDA Product Code
- HHT FDA UDI
- GMDN Term
- Cytology scraper, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cytology scraper, single-use
Rovers® Viba-Brush® by Rovers Medical Devices B.V. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cytology scraper, single-use.
- Barrx — Covidien LP · Class I
- CerfiSoft Foam Cytology Collection Swab — PURITAN MEDICAL PRODUCTS COMPANY LLC · Class II
- Papette — CooperSurgical, Inc. · Class II
- Grafco — GF Health Products, Inc · Class II
- HOLOGIC — CooperSurgical, Inc. · Class II
- EsoCheck CCD Cell Collection Device — LUCID DIAGNOSTICS, INC. · Class II
- LabChoice Cell Scraper, Sterile, 25 cm — Dynarex Corp. · Class I
- Puritan Histobrush — PURITAN MEDICAL PRODUCTS COMPANY LLC · Class II
Cleared under the same submission
K933870 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Rovers Medical Devices B.V.
Sources (2)
- FDA UDI 67310b79-950c-4f4c-ac06-8734a3ad604c 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026