Cytology Brush

Basic Information

• Brand Name: Cytology Brush
• Primary DI: B634MBR0000150
• Version / Model: MBR-000015
• Catalog Number: MBR-000015
• Company Name: AURIS HEALTH, INC.
• Labeler DUNS: 015823456
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-08
• Public Version: 1
• Public Version Date: 2018-07-09
• Public Version Status: New
• Public Device Record Key: 6088b6e5-a52a-404a-bcaf-84ba02369880

Device Description

Cytology Brush

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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	874.4680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38834	Flexible endoscopic cytology brush, single-use	A device intended to be used in combination with a compatible flexible endoscope to collect cells of the mucosa for pathological diagnosis during endoscopy. It is inserted through the working channel of the endoscope and consists of a flexible insertion portion made of a metal coil or plastic tube, whose distal end is equipped with plastic bristles for harvesting mucosal cells, e.g., during bronchoscopy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B634MBR0000151	HIBCC	Box	5	In Commercial Distribution
Primary	B634MBR0000150	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K173760	000