FDA.report

Rovers® Cervex-Brush® RT

Primary DI
08719189246247
Brand
Rovers® Cervex-Brush® RT
Company
Rovers Medical Devices B.V.
Model
380300324
Device description
Cervical cell sampler
Published
2018-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HHTSpatula, Cervical, Cytological

Product Code Classifications

CodeDeviceSpecialtyClass
HHTSpatula, Cervical, CytologicalObstetrics/Gynecology2

Premarket Submissions

SubmissionSupplement
K930955000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K930955000CERVEX-BRUSHRovers B.V.1994-05-24HHT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
18719189246244PackageGS120In Commercial Distribution
08719189246247PrimaryGS10
08719189246230Unit of UseGS10

GMDN Terms

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

Contacts

PhoneEmail
+31412648870info@roversmedicaldevices.com

Regulatory Flags

DUNS number
402155084
Device count
25
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
true
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 DIBrandModelCatalogPublished
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
28719189246296Rovers® EndoCervex-Brush®-S 3801007452023-07-12
28719189246395Rovers® Cervex-Brush®3803003312023-07-12
08719189246476Rovers® Cervex-Brush® Combi3803010312023-07-12
87191892466018Rovers® Cervex-Brush®3801003112017-10-20
08719189246056Rovers® Cervex-Brush® 3801003312017-10-19
08719189246070Rovers® Cervex-Brush® Combi3801010002018-07-16
08719189246131Rovers® EndoCervex-Brush® -S3801007402018-07-16
08719189246155Rovers® Cervex-Brush® Combi 3801010312017-10-19
08719189246162Rovers® Orcellex® Brush RT 3803803312017-10-22
08719189246186Rovers® Cervex-Brush® Combi RT3803010002018-07-16
08719189246308Rovers® EndoCervex-Brush®-S RT 3803007452017-10-19

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