Hobbs Nasal Cytology Brush

Basic Information

• Brand Name: Hobbs Nasal Cytology Brush
• Primary DI: M84942910
• Version / Model: 4291
• Catalog Number: 4291
• Company Name: HOBBS MEDICAL, INC.
• Labeler DUNS: 076769355
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 5
• Public Version Date: 2024-03-04
• Public Version Status: Update
• Public Device Record Key: f5927aaa-3db5-4ca7-95ab-128376b143a5

Device Description

The Nasal Cytology Brush consists of bristles at the distal end which is then set into a handle that is intended to collect cells from the nasal passages. The cells are used for histopathological analysis. This is a single-use device.

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: Yes
• 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: Yes
• 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
GEE	Brush, Biopsy, General & Plastic Surgery	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46388	General-purpose cytology brush	A sterile device consisting of tufts or bristles set into a handle that is intended to collect cells from an area of the body, typically during an open surgical procedure. The cells are used for histopathological analysis. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M84942912	HIBCC	Box	10	In Commercial Distribution
Primary	M84942910	HIBCC

Customer Contacts

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