Monoart

Basic Information

• Brand Name: Monoart
• Primary DI: E307220103040
• Version / Model: MONOART APRON PG30
• Catalog Number: 22010304
• Company Name: EURONDA SPA
• Labeler DUNS: 428755441
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-16
• Public Version: 1
• Public Version Date: 2019-12-24
• Public Version Status: New
• Public Device Record Key: 2e6b1041-04e8-4e2b-9992-618c748a9fa6

Device Description

Roll of 80 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 610 x 530 mm. Carton of 6 rolls. 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
61048	Patient examination/treatment drape, single-use	A non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during an examination or non-surgical treatment procedure in the home or healthcare facility primarily to prevent soiling/cross-contamination; it is not intended for surgical use. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	E307220103041	HIBCC	Carton	6	In Commercial Distribution
Package	E307220103042	HIBCC	Aprons	80	In Commercial Distribution
Primary	E307220103040	HIBCC