Avaline Medical NJ LLC

Basic Information

• Brand Name: Avaline Medical NJ LLC
• Primary DI: 00653078997552
• Version / Model: CR 1LBx1
• Catalog Number: CR 1LBx1
• Company Name: Avaline Medical NJ Limited Liability Company
• Labeler DUNS: 079767953
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-15
• Public Version: 2
• Public Version Date: 2024-01-12
• Public Version Status: Update
• Public Device Record Key: 14430c00-6967-4ed1-9324-00e087b3e91e
• Distribution End Date: 2024-01-11

Device Description

Nonsterile Cotton Rolls 1lb

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• 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
EFN	COTTON, ROLL	Dental	872.6050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58232	Cotton wool roll	A device designed as an absorbent mass of cotton or man-made fibres formed in a continuous length (roll) and typically used as a general-purpose absorbent or padding within the healthcare sector or the home; it is not in the form of a bandage or dedicated dressing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00653078997552	GS1

Customer Contacts

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