LEONE SPA

Basic Information

• Brand Name: LEONE SPA
• Primary DI: 08033707102670
• Version / Model: M3053-01
• Catalog Number: M3053-01
• Company Name: LEONE SPA
• Labeler DUNS: 432167294
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-24
• Public Version: 1
• Public Version Date: 2022-09-01
• Public Version Status: New
• Public Device Record Key: 3f1e20e0-eab5-4866-b55b-fc47bf87c768

Device Description

LIP BUMPER 045 W/LOOPS STOP/HOOKS no. 1

Device Characteristics

• Single Use: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EHP	Clasp, Preformed	Dental	872.3285	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16204	Orthodontic wire	A thread or slender rod of metal (e.g., stainless steel, precious metal) incorporated into an orthodontic appliance, typically as part of an orthodontic appliance system. It is available in various dimensions and grades, and is used to exert pressure on teeth in order to alter their position. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08033707102670	GS1