FDA.reportPublic FDA data

ROVERS® CERVEX-BRUSH®

Primary DI
10382904905245
Brand
ROVERS® CERVEX-BRUSH®
Company
TRIPATH IMAGING, INC.
Model
490524
Catalog number
490524
Device description
ROVERS® CERVEX-BRUSH®
Published
2016-09-24
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
30382904905249PackageGS120In Commercial Distribution
10382904905245PrimaryGS10
00382904905248Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290490524930382904905249
1038290490524510382904905245
00382904905248003829049052483829049052480382904905248

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
+1(800)638-8663Technical_Services@bd.com

Regulatory Flags#

DUNS number
103318015
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10382904912533BD SurePath™ Collection Vial Kit 5004912534912532017-09-08
10382904905269Rovers ® Combo-brush® 4905264905262016-09-24
00382904913083BD Totalys™ SlidePrep Consumables Kit4913084913082016-06-23
00382904913113BD PrepStain™ Consumables Kit4913114913112017-09-08
00382904913137BD PrepMate™ Consumables Kit4913134913132017-09-08
00382904913106BD Totalys™ MultiProcessor Consumables Kit4913104913102016-06-23
30382904913244BD SurePath™ Collection Vial Kit 254913244913242016-06-23
30382904913299BD Settling Chambers4913294913292015-05-05
30382904913305BD Settling Chambers4913304913302015-05-05
00382904912475BD SurePath4912474912472017-09-08
00382904913069BD Density Reagent4913064913062017-09-08
00382904913885BD Totalys™ SlidePrep Slide Library Kit4913884913882016-06-23
30382904905119BD SurePath4905114905112015-07-23
30382904905171PrepStain® Syringing Pipettes 4905174905172015-05-05
30382904905201PrepStain® Settling Chambers4905204905202015-05-05
30382904905225BD SurePath4905224905222015-07-23
00382904901042BD PrepStain Slide Processor4901044901042015-07-22
00382904904104BD PrepStain Slide Processor4904104904102015-07-22
00382904905071BD SurePath4905074905072015-07-22
00382904905217BD PrepStain4905214905212015-07-22

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