Rovers® Evalyn® Brush

Basic Information

• Brand Name: Rovers® Evalyn® Brush
• Primary DI: 18719189246435
• Version / Model: 380500131
• 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: 2019-12-11
• Public Version: 1
• Public Version Date: 2019-12-19
• Public Version Status: New
• Public Device Record Key: 2d3f2aac-6ef4-4cd2-8b9a-9b791b82f55a

Device Description

Vaginal cell sampler, sterile

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	880.6025	1

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
Primary	18719189246435	GS1
Unit of Use	08719189246438	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]