MEDLINE UNITE

Basic Information

• Brand Name: MEDLINE UNITE
• Primary DI: 10888277690653
• Version / Model: MFSN2416
• Catalog Number: MFSN2416
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-29
• Public Version: 1
• Public Version Date: 2019-12-09
• Public Version Status: New
• Public Device Record Key: 22751dbf-5e02-43c4-8b43-b8a3ad02d5d9

Device Description

SCREW, NON-LOCKING, MINI, 2.4 X 16MM

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• 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
HWC	Screw, fixation, bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47996	Orthodontic anchor plate	A small metallic plate that is implanted intraorally to serve as a temporary anchor for an orthodontic device (e.g., a spring). It is available in various sizes and lengths and is anchored to the jawbone with dedicated bone screws. It is used in a variety of orthodontic treatment situations, especially when normal anatomy has been compromised (e.g., due to periodontal disease or agenesis, displacement of teeth in the same direction, asymmetrical anatomy). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888277690653	GS1

Customer Contacts

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