Monoart

Basic Information

• Brand Name: Monoart
• Primary DI: E3072902051
• Version / Model: KIT MONOART® 5P 15,0 FIXED
• Catalog Number: 290205
• Company Name: EURONDA SPA
• Labeler DUNS: 428755441
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-25
• Public Version: 2
• Public Version Date: 2020-05-06
• Public Version Status: Update
• Public Device Record Key: 7ab5be3b-3756-4ca5-8189-5c0f2ea61a38

Device Description

Practical kit Monoart containing 5 different disposable products for 500 patients: 500 Towel Up, 500 saliva ejectors fix, 500 plastic cups, 200 Masks Pro.3, 160 Aprons PG30/80. Colour: orange

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
KHR	Absorber, Saliva, Paper	Dental	872.6050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35177	Surgical/medical face mask, single-use	A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device.	No	Obsolete
37434	Dental suction system cannula, single-use	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 typically made of disposable plastic materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E3072902051	HIBCC