Monoart

Basic Information

• Brand Name: Monoart
• Primary DI: E307220103010
• Version / Model: MONOART APRON PG30
• Catalog Number: 22010301
• 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: df9e7ab7-11f0-409c-a030-c11a670ae49c

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: green.

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
Primary	E307220103010	HIBCC
Package	E307220103012	HIBCC	Aprons	80	In Commercial Distribution
Package	E307220103011	HIBCC	Carton	6	In Commercial Distribution