Morelli

Basic Information

• Brand Name: Morelli
• Primary DI: 07895742002749
• Version / Model: 75.01.007
• Catalog Number: 75.01.007
• Company Name: Dental Morelli Ltda
• Labeler DUNS: 907156371
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-15
• Public Version: 1
• Public Version Date: 2021-05-24
• Public Version Status: New
• Public Device Record Key: 71e2fb8f-c03c-4830-891f-a354fbd880c9

Device Description

Band Marker 5.0 - 4.5 - 4.0 - 3.5 mm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Dry Heat Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ECR	SETTER, BAND, ORTHODONTIC	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62072	Orthodontic elastomeric appliance pusher	A hand-held device intended to be used by laypersons to remove/apply orthodontic elastomeric appliances (e.g., inter-arch bands, inter-bracket chains) from/to orthodontic brackets. It is typically a thin plastic device with a hook on one end and a pusher on the other, intended to be used by a patient in the home (e.g., before and after eating or sleep). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07895742002749	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]