Luno

Basic Information

• Brand Name: Luno
• Primary DI: 00190746062858
• Version / Model: 001-038538
• Catalog Number: 001-038538
• Company Name: AMERICAN ORTHODONTICS CORPORATION
• Labeler DUNS: 044668515
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-21
• Public Version: 1
• Public Version Date: 2025-05-29
• Public Version Status: New
• Public Device Record Key: 36e45117-358a-488c-b00f-603486a4cb3a

Device Description

INSTRUMENT LUNO EMPOWER OPENING/CLOSING

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: Yes
• 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
ECP	INSTRUMENT, LIGATURE TUCKING, ORTHODONTIC	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37413	Orthodontic ligature director	A hand-held dental instrument used to tuck and direct ligatures under the archwire or bracket wings or to push archwires or auxiliaries into position. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190746062858	GS1

Customer Contacts

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