MILLENNIUM

Basic Information

• Brand Name: MILLENNIUM
• Primary DI: 00190776293147
• Version / Model: 85-2511035
• Company Name: Avalign Technologies, Inc.
• Labeler DUNS: 792528510
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-28
• Public Version: 1
• Public Version Date: 2023-10-06
• Public Version Status: New
• Public Device Record Key: fd46520f-56bb-4db0-9e99-5534ab1f5dc5

Device Description

Drill Bit QC/AO

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
HTW	BIT, DRILL	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11330	Biopsy drill bit	A shaft of metal designed to excise (cut out) a small section of bone or cartilage for microscopic examination. It is mounted into a surgical drilling device, either manual or powered, and when rotated at an appropriate speed will perform the required operation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190776293147	GS1

Customer Contacts

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