Rovers® Cervex-Brush® Combi

Primary DI
08719189246476
Brand
Rovers® Cervex-Brush® Combi
Company
Rovers Medical Devices B.V.
Model
380301031
Published
2023-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
K043369000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043369000CERVEX-BRUSH COMBIRovers Medical Devices B.V.2005-02-02HHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719189246476PackageGS16In Commercial Distribution
28719189246609PackageGS120In Commercial Distribution
18719189246602PrimaryGS10
08719189246605Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719189246476087191892464768719189246476
2871918924660928719189246609
1871918924660218719189246602
08719189246605087191892466058719189246605

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

Regulatory Flags#

DUNS number
402155084
Device count
100
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
false
Sterilization required before use
false

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