Millennium

Basic Information

• Brand Name: Millennium
• Primary DI: 00190776158019
• Version / Model: 72-SM240221CH01
• Company Name: Avalign Technologies, Inc.
• Labeler DUNS: 792528510
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-23
• Public Version: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: f91fd78b-7c7d-42fe-99df-65a9c767e775

Device Description

Special Made ENT Suction Handle

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: No
• 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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60067	B-cell acute lymphoblastic leukaemia (B-ALL) genetic mutation IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict B-cell acute lymphoblastic leukaemia (B-ALL) based on chromosomal changes, which may include t(12;21), t(4;11), t(9;22) and/or t(1;19) translocations, using a nucleic acid technique (NAT).	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190776158019	GS1

Customer Contacts

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