Monoart

Basic Information

• Brand Name: Monoart
• Primary DI: E3072620070
• Version / Model: MONOART BANDANA
• Catalog Number: 262007
• Company Name: EURONDA SPA
• Labeler DUNS: 428755441
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-17
• Public Version: 2
• Public Version Date: 2021-12-22
• Public Version Status: Update
• Public Device Record Key: 566dfa20-f382-4c95-acd9-74bc870255a1

Device Description

This Personal Protective Equipment (P.P.E.) is designed and manufactured exclusively to protect the user against minor or easily reversible impacts resulting from the use of mechanical equipment and/or cleaning products. This P.P.E. also protects against: risks due to contact with hot components having a temperature not exceeding 50°C (normal environmental conditions when working); minor impacts. It is not suitable to protect against the following risks: chemical, heat, fire, cold, poor visibility and electric shock. Monoart bandana with adjustable ties that can fit all sizes. Thanks to the top-quality, colour-fast cotton used, it is autoclavable at 121°C. Single pack, carton of 10 pieces of the same colour. Colour: pink

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
FYF	Cap, Surgical	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38260	Surgical cap, reusable	A head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of woven materials. This is a reusable garment intended to be laundered after each use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	E3072620071	HIBCC	Carton	10	In Commercial Distribution
Primary	E3072620070	HIBCC