Rovers® EndoCervex-Brush®-S

Primary DI
28719189246296
Brand
Rovers® EndoCervex-Brush®-S
Company
Rovers Medical Devices B.V.
Model
380100745
Device description
The EndoCervex-Brush®-S is a single-use cell sampler Intended to collect endocervical cells in women.
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
K001119000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001119000ROVERS ENDOCERVEX-BRUSHRovers Medical Devices B.V.2000-05-19HHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719189246520PackageGS16In Commercial Distribution
28719189246296PackageGS120In Commercial Distribution
18719189246299PrimaryGS10
08719189246292Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719189246520087191892465208719189246520
2871918924629628719189246296
1871918924629918719189246299
08719189246292087191892462928719189246292

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
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08809157488226C27024B&B Company Co.,Ltd.HHT2023-07-17
08809157488233C27024B&B Company Co.,Ltd.HHT2023-07-17
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08809157488325C27632B&B Company Co.,Ltd.HHT2023-07-17
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08809157488349C27632B&B Company Co.,Ltd.HHT2023-07-17
08809157488417C29000B&B Company Co.,Ltd.HHT2023-07-17
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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