Millennium

Basic Information

• Brand Name: Millennium
• Primary DI: 00190776350109
• Version / Model: 63-G16471
• Company Name: Avalign Technologies, Inc.
• Labeler DUNS: 792528510
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-12
• Public Version: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 89b3c2f0-ae69-4fff-ad84-b8f41d70a2d3

Device Description

Laparotomy Ring

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
FHI	RING, LAPAROTOMY	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32098	Laparotomy ring	A surgical instrument designed in the shape of a circular band that is set into the abdominal wall to hold open an incision during surgery on the abdominal organs. It functions as a fixed-length access retractor or wound retractor and is used in procedures where entry of the surgeon's hand into the abdominal cavity may facilitate the procedure, and for the extraction of large specimens. This device is used in colorectal, urological, gynaecological, and general surgical procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190776350109	GS1

Customer Contacts

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