Rovers ® Combo-brush®

Basic Information

• Brand Name: Rovers ® Combo-brush®
• Primary DI: 10382904905269
• Version / Model: 490526
• Catalog Number: 490526
• Company Name: TRIPATH IMAGING, INC.
• Labeler DUNS: 103318015
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2021-10-01
• Public Version Status: Update
• Public Device Record Key: 0278b9ec-ab5f-45ef-9484-be47dca49f8c
• Distribution End Date: 2021-10-01

Device Description

Rovers ® Cervex-Brush® Combi

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
Primary	10382904905269	GS1
Unit of Use	00382904905262	GS1
Package	30382904905263	GS1	Shelf Pack	20	Not in Commercial Distribution	2021-10-01

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K043369	000