FDA.reportPublic FDA data

Rovers® Cervex-Brush®

Primary DI
87191892460252
Brand
Rovers® Cervex-Brush®
Company
Rovers Medical Devices B.V.
Model
380100324
Device description
Cervical cell sampler
Published
2016-10-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHTSpatula, Cervical, Cytological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHTSpatula, Cervical, CytologicalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930955000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930955000CERVEX-BRUSHRovers B.V.1994-05-24HHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
87191892460320PackageGS120In Commercial Distribution
87191892460252PrimaryGS10
08719189246049Unit of UseGS10
87191892460498Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
8719189246032087191892460320
8719189246025287191892460252
08719189246049087191892460498719189246049
8719189246049887191892460498

GMDN Terms#

Term, Definition table
TermDefinition
Cytology scraper, single-useA wooden, plastic, or metal instrument used to collect a scraping of cells from tissue for the purposes of a diagnostic examination. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+31412648870info@roversmedicaldevices.com

Regulatory Flags#

DUNS number
402155084
Device count
25
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18719189246015Rovers® Anex® Brush 3800903312023-07-12
18719189246084Rovers® Cervex-Brush® Combi3801020312023-07-12
18719189246213Rovers® Viba-Brush®3802001312023-07-12
18719189246220Rovers® Viba-Brush®3802003312023-07-12
18719189246251Rovers® Viba-Brush®3803203312023-07-12
18719189246268Rovers® Cervex-Brush® 3801004312023-07-12
18719189246275Rovers® EndoCervex-Brush®3803007312023-07-12
18719189246282Rovers® EndoCervex-Brush®3801007312023-07-12
18719189246299Rovers® EndoCervex-Brush®-S 3801007452023-07-12
18719189246398Rovers® Cervex-Brush®3803003312023-07-12
18719189246602Rovers® Cervex-Brush® Combi3803010312023-07-12
08719189246445Rovers® Evalyn® Brush3805001502023-07-12
08719189246544Rovers® Anex® Brush 3800903312023-07-12
28719189246081Rovers® Cervex-Brush® Combi3801020312023-07-12
08719189246575Rovers® Viba-Brush®3802001312023-07-12
28719189246227Rovers® Viba-Brush®3802003312023-07-12
28719189246258Rovers® Viba-Brush®3803203312023-07-12
08719189246261Rovers® Cervex-Brush® 3801004312023-07-12
08719189246551Rovers® EndoCervex-Brush®3803007312023-07-12
08719189246513Rovers® EndoCervex-Brush®3801007312023-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011506300CytoSoftMedical Packaging CorporationHHT2026-02-18
00860011506324CytoSoftMedical Packaging CorporationHHT2026-02-18
00860011506331CYTO-PAKMedical Packaging CorporationHHT2026-02-18
07898027908460KOLPLASTKolplast C IHHT2023-11-29
08809157488011C20310B&B Company Co.,Ltd.HHT2023-07-17
08809157488028C20310B&B Company Co.,Ltd.HHT2023-07-17
08809157488035C20310B&B Company Co.,Ltd.HHT2023-07-17
08809157488042C20310B&B Company Co.,Ltd.HHT2023-07-17
08809157488110C21150B&B Company Co.,Ltd.HHT2023-07-17
08809157488127C21150B&B Company Co.,Ltd.HHT2023-07-17
08809157488134C21150B&B Company Co.,Ltd.HHT2023-07-17
08809157488141C21150B&B Company Co.,Ltd.HHT2023-07-17
08809157488219C27024B&B Company Co.,Ltd.HHT2023-07-17
08809157488226C27024B&B Company Co.,Ltd.HHT2023-07-17
08809157488233C27024B&B Company Co.,Ltd.HHT2023-07-17
08809157488240C27024B&B Company Co.,Ltd.HHT2023-07-17
08809157488318C27632B&B Company Co.,Ltd.HHT2023-07-17
08809157488325C27632B&B Company Co.,Ltd.HHT2023-07-17
08809157488332C27632B&B Company Co.,Ltd.HHT2023-07-17
08809157488349C27632B&B Company Co.,Ltd.HHT2023-07-17
08809157488417C29000B&B Company Co.,Ltd.HHT2023-07-17
08809157488424C29000B&B Company Co.,Ltd.HHT2023-07-17
08809157488431C29000B&B Company Co.,Ltd.HHT2023-07-17
08809157488448C29000B&B Company Co.,Ltd.HHT2023-07-17
08809157488516C60100B&B Company Co.,Ltd.HHT2023-07-17
08809157488523C60100B&B Company Co.,Ltd.HHT2023-07-17
08809157488530C60100B&B Company Co.,Ltd.HHT2023-07-17
08809157488547C60100B&B Company Co.,Ltd.HHT2023-07-17
18719189246084Rovers® Cervex-Brush® CombiRovers Medical Devices B.V.HHT2023-07-12
18719189246213Rovers® Viba-Brush®Rovers Medical Devices B.V.HHT2023-07-12