Rovers® Cervex-Brush®

Basic Information

• Brand Name: Rovers® Cervex-Brush®
• Primary DI: 18719189246398
• Version / Model: 380300331
• Company Name: Rovers Medical Devices B.V.
• Labeler DUNS: 402155084
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-07-12
• Public Version: 1
• Public Version Date: 2023-07-20
• Public Version Status: New
• Public Device Record Key: 2bd720bd-4072-41f3-b719-05ad0060137f

Device Description

The Cervex-Brush® is a single-use cell sampler intended to collect simultaneous cell material from the cervical os, ectocervical and endo cervical canal in women.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42537	Cytology scraper, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	28719189246395	GS1		20	In Commercial Distribution
Primary	18719189246398	GS1
Package	08719189246421	GS1		6	In Commercial Distribution
Unit of Use	08719189246391	GS1

Premarket Submissions

Submission Number	Supplement Number
K930955	000