Morelli

Basic Information

• Brand Name: Morelli
• Primary DI: 07895742116125
• Version / Model: 75.01.038
• Catalog Number: 75.01.038
• Company Name: Dental Morelli Ltda
• Labeler DUNS: 907156371
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-30
• Public Version: 2
• Public Version Date: 2021-07-22
• Public Version Status: Update
• Public Device Record Key: c2b9c8ec-5f58-4136-aaba-2d8b0d3f7529

Device Description

Orthodontic Long Key for Expansion Screw Activation

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
DZN	INSTRUMENTS, DENTAL HAND	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64768	Orthodontic palate expander screw key	A hand-held device designed to manually adjust an orthodontic palate expander (not included), by rotating the expander’s screw, to help create space for correct upper teeth alignment. It is comprised of a handle with an expander-engaging pin at the distal end which is inserted into the screw and rotated to adjust the width of the expander. This is a reusable device intended for single patient use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07895742116125	GS1

Customer Contacts

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