LEONE SPA

Basic Information

• Brand Name: LEONE SPA
• Primary DI: 08033707068280
• Version / Model: M4805-03
• Catalog Number: M4805-03
• Company Name: LEONE SPA
• Labeler DUNS: 432167294
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-25
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 81f3453d-55b5-44b2-b0c2-213743b21e06

Device Description

EXORAL FACEBOW 045 W/LOOPS LONG n. 3

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
DZB	Headgear, Extraoral, Orthodontic	Dental	872.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40468	Orthodontic face bow	A dental device used in conjunction with extraoral traction anchored on the back of the head or neck, as a long metal bow that inserts intraorally into an orthodontic appliance. Generally used to move teeth or bones posteriorly or prevent their forward movement.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08033707068280	GS1