Rovers® EndoCervex-Brush®

Basic Information

• Brand Name: Rovers® EndoCervex-Brush®
• Primary DI: 87191892461006
• Version / Model: 380100703
• Company Name: Rovers Medical Devices B.V.
• Labeler DUNS: 402155084
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-10-03
• Public Version: 4
• Public Version Date: 2019-09-12
• Public Version Status: Update
• Public Device Record Key: 454bdc03-495f-48c8-99b9-330915aa58c4
• Distribution End Date: 2018-08-01

Device Description

EndoCervical cell sampler

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: 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: No
• 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	87191892461174	GS1	Box	20	Not in Commercial Distribution	2018-08-01
Primary	87191892461006	GS1
Unit of Use	87191892460948	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K001119	000