Millennium

Basic Information

• Brand Name: Millennium
• Primary DI: 00190776375522
• Version / Model: 75-1681510
• Company Name: Avalign Technologies, Inc.
• Labeler DUNS: 792528510
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-23
• Public Version: 3
• Public Version Date: 2023-09-11
• Public Version Status: Update
• Public Device Record Key: 555ae654-976e-4807-9f13-cc18fc09bdfc

Device Description

Erich Arch Bar Material

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
44808	Maxillofacial bone wire/bar	A length of metal (e.g., stainless steel) intended to stabilize bony fragments (fractured bone) in the oral cavity and/or stabilize injured teeth. Stabilization occurs by direct application of the device to the bone/teeth (e.g., by wrapping the ligature around fractured bone segments and locking the ends together). The device may be used for intermaxillary fixation, maxillomandibular fixation, or other forms of jaw immobilization. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190776375522	GS1

Customer Contacts

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