Avaline Medical NJ LLC

Basic Information

• Brand Name: Avaline Medical NJ LLC
• Primary DI: 00810077211878
• Version / Model: vk024tb
• Catalog Number: vk024tb
• Company Name: Avaline Medical NJ Limited Liability Company
• Labeler DUNS: 079767953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2021-10-15
• Public Version: 1
• Public Version Date: 2021-10-25
• Public Version Status: New
• Public Device Record Key: 7a7d8de3-9a60-48b2-bf7d-e645b8854c9c

Device Description

Disposable Toothbrushes 24

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EFW	TOOTHBRUSH, MANUAL	Dental	872.6855	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31817	Basic manual toothbrush	An instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device is typically used with toothpaste. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00810077212134	GS1
Primary	00810077211878	GS1

Customer Contacts

• Phone: [phone] ext. 204
• Email: [email protected]