FDA.reportPublic FDA data

Rovers® Orcellex® Brush RT

Primary DI
08719189246162
Brand
Rovers® Orcellex® Brush RT
Company
Rovers Medical Devices B.V.
Model
380380331
Device description
Oral cell sampler, sterile
Published
2017-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEEBrush, Biopsy, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEEBrush, Biopsy, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719189246537PackageGS16In Commercial Distribution
18719189246169PackageGS120In Commercial Distribution
08719189246162PrimaryGS10
08719189246322Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719189246537087191892465378719189246537
1871918924616918719189246169
08719189246162087191892461628719189246162
08719189246322087191892463228719189246322

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
+31412648870info@roversmedicaldevices.com

Regulatory Flags#

DUNS number
402155084
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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
00850068304851SBHSBH SurgicalGEE2026-05-08
00190776420970MillenniumAvalign Technologies, Inc.GEE2026-04-30
00860011506348SWAB-PAKMedical Packaging CorporationGEE2026-02-18
00860011506355SWAB-PAKMedical Packaging CorporationGEE2026-02-18
00816207021720Biopsy BrushENDO-THERAPEUTICS, INC.GEE2025-02-26
06971317521769StatLabYancheng Huida Medical Instruments Co., Ltd.GEE2024-05-01
06971317521776StatLabYancheng Huida Medical Instruments Co., Ltd.GEE2024-05-01
16971317521766StatLabYancheng Huida Medical Instruments Co., Ltd.GEE2024-05-01
16971317521773StatLabYancheng Huida Medical Instruments Co., Ltd.GEE2024-05-01
00190776300708MillenniumAvalign Technologies, Inc.GEE2023-11-15
00190776301637MillenniumAvalign Technologies, Inc.GEE2023-11-15
00816207021027Single Use Brush Biopsy InstrumentENDO-THERAPEUTICS, INC.GEE2022-12-09
00816207021041Single Use Brush Biopsy InstrumentENDO-THERAPEUTICS, INC.GEE2022-12-09
00816207021690Single Use Brush Biopsy InstrumentENDO-THERAPEUTICS, INC.GEE2022-12-09
00816207021706Single Use Brush Biopsy InstrumentENDO-THERAPEUTICS, INC.GEE2022-12-09
00816207021713Single Use Brush Biopsy InstrumentENDO-THERAPEUTICS, INC.GEE2022-12-09
00190776198176MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198183MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198190MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198206MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198213MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198220MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198237MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198244MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198251MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198268MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198275MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198282MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198299MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198305MillenniumAvalign Technologies, Inc.GEE2021-11-02