Hobbs Microbiology Brush

Basic Information

• Brand Name: Hobbs Microbiology Brush
• Primary DI: M84943100
• Version / Model: 4310
• Catalog Number: 4310
• 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: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 59f070d8-5c7b-46e3-93d7-a7c41cb493d5

Device Description

The Hobbs Microbiology Brush is 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 inside a plastic tube, whose distal end is equipped with plastic bristles for harvesting and protecting mucosal cells, e.g., during endoscopy. 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: No
• 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
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	876.1500	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
Primary	M84943100	HIBCC
Package	M84943101	HIBCC	Box	5	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K893729	000