Rovers® EndoCervex-Brush®

Basic Information

• Brand Name: Rovers® EndoCervex-Brush®
• Primary DI: 18719189246282
• Version / Model: 380100731
• 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: 5cdc8443-ca7b-4d98-b4ab-107227c54317

Device Description

The EndoCervex-Brush® is a single-use cell sampler intended to collect endocervical cells.

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	08719189246513	GS1		6	In Commercial Distribution
Primary	18719189246282	GS1
Package	28719189246289	GS1		20	In Commercial Distribution
Unit of Use	08719189246285	GS1

Premarket Submissions

Submission Number	Supplement Number
K001119	000