Monoart

Basic Information

• Brand Name: Monoart
• Primary DI: E30722910110
• Version / Model: MONOART EM40
• Catalog Number: 22910110
• Company Name: EURONDA SPA
• Labeler DUNS: 428755441
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-09
• Public Version: 1
• Public Version Date: 2019-12-17
• Public Version Status: New
• Public Device Record Key: 620f21b4-2381-45f8-8ade-91229cff4fcc

Device Description

Universal moulded tip for surgical aspirator. It can be sterilised in autoclave at 134°C. Medical Device Class Ila. Connection diameter: 11mm. Lenght: 200mm. Box of 10 pcs. Color: light grey

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38759	Dental suction system cannula, reusable	A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is made of metal or plastic materials that can be sterilized. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E30722910110	HIBCC
Package	E307229101101	HIBCC	box	10	In Commercial Distribution
Package	E307229101102	HIBCC	carton	10	In Commercial Distribution