FDA.reportPublic FDA data

Rovers® Anex® Brush

Primary DI
08719189246544
Brand
Rovers® Anex® Brush
Company
Rovers Medical Devices B.V.
Model
380090331
Device description
The Anex® Brush is a single-use cell sampler intended to collect cells from the anal canal.
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
KXGApplicator, Absorbent Tipped, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXGApplicator, Absorbent Tipped, SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719189246544PackageGS16In Commercial Distribution
28719189246012PackageGS120In Commercial Distribution
18719189246015PrimaryGS10
08719189246018Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719189246544087191892465448719189246544
2871918924601228719189246012
1871918924601518719189246015
08719189246018087191892460188719189246018

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
true
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
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

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