Avaline Medical NJ LLC

Basic Information

• Brand Name: Avaline Medical NJ LLC
• Primary DI: 00810077210215
• Version / Model: EMWSC 2x10
• Catalog Number: EMWSC 2x10
• Company Name: Avaline Medical NJ Limited Liability Company
• Labeler DUNS: 079767953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-03-05
• Public Version: 1
• Public Version Date: 2022-03-14
• Public Version Status: New
• Public Device Record Key: d8d34fca-ae0a-430c-b8c3-4620903a977b

Device Description

2 inch Elastic Bandage Wrap with Self-Closure [Pack of 10]

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
FQM	BANDAGE, ELASTIC	General Hospital	880.5075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44481	Ankle binder, reusable	A strip or roll of fabric or plastic material designed to be wrapped around the ankle to help stabilize and support the joint. It does not include a rigid support (i.e., not an ankle/foot orthosis) and is not a tubular support bandage. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00810077212905	GS1
Primary	00810077210215	GS1

Customer Contacts

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