Avaline Medical NJ LLC

Basic Information

• Brand Name: Avaline Medical NJ LLC
• Primary DI: 00810077210123
• Version / Model: vdcr100
• Catalog Number: vdcr100
• Company Name: Avaline Medical NJ Limited Liability Company
• Labeler DUNS: 079767953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2021-03-10
• Public Version: 2
• Public Version Date: 2022-03-23
• Public Version Status: Update
• Public Device Record Key: 36a12985-5008-4f82-a0b4-416a79da8dfc

Device Description

100 Dental Cotton Rolls

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
EFN	COTTON, ROLL	Dental	872.6050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31815	Dental cotton roll	A non-sterile designed as an absorbent, non-sterile mass of cotton or man-made fibres formed as a small, short, hard-packed cylinder (a roll) that is used as a saliva absorber and intended to absorb moisture from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00810077210116	GS1
Primary	00810077210123	GS1
Previous	00667605030063	GS1

Customer Contacts

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