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510(k) Data Aggregation
K Number
K043369Device Name
CERVEX-BRUSH COMBI
Manufacturer
ROVERS MEDICAL DEVICES B.V.
Date Cleared
2005-02-02
(56 days)
Product Code
HHT
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
ROVERS MEDICAL DEVICES B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cervex-Brush Combi is intended for the collection of cervical cells for analysis by Pap smear methods and / or by methods for detecting sexually transmitted disease (STD). The Cervex-Brush Combi is not intended for use in pregnant women.
Device Description
This device consists of handle with a multi-bristled, soft plastic brush mounted on it. The bristles are intended to collect cervical cells for testing and evaluation. For the middle part of the Cervex-Brush Combi the cell-collecting ability of the device is comprised of substantially eccentrically placed parallel plastic bristles, forming a brush head that is connected to the handle. The eccentrically placed bristles are positioned on opposite sides of a square base. The top of the brush is rounded. Digital rotation with gentle pressure by way of the handle causes to scrape and remove cytological material simultaneously from the ectocervix and the endocervix. Because the bristles are plastic, wet or humid cells are not absorbed so that the cytological material can easily be transferred to a glass slide or a preservative fluid and sent to the laboratory for evaluation. The device is offered sterile and nonsterile. The Cervex-Brush Combi head is composed of polyethylene, the same material that is used for the Cervex- Brush.
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K Number
K002520Device Name
ROVERS SPATULA
Manufacturer
ROVERS MEDICAL DEVICES B.V.
Date Cleared
2000-11-13
(90 days)
Product Code
HHT
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
ROVERS MEDICAL DEVICES B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001119Device Name
ROVERS ENDOCERVEX-BRUSH
Manufacturer
ROVERS MEDICAL DEVICES B.V.
Date Cleared
2000-05-19
(42 days)
Product Code
HHT
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
ROVERS MEDICAL DEVICES B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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