Avaline Medical NJ LLC

Basic Information

• Brand Name: Avaline Medical NJ LLC
• Primary DI: 00647679163003
• Version / Model: CETP18x2.2
• Catalog Number: CETP18x2.2
• Company Name: Avaline Medical NJ Limited Liability Company
• Labeler DUNS: 079767953
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2021-12-03
• Public Version: 2
• Public Version Date: 2022-03-16
• Public Version Status: Update
• Public Device Record Key: c79dfb6a-c7b6-4aa3-aaa7-5290628fd3e6
• Distribution End Date: 2022-03-15

Device Description

18''x125’ Standard White Crepe Exam Table Paper Pack Of 2

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
KME	BEDDING, DISPOSABLE, MEDICAL	General Hospital	880.6060	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35880	Examination/treatment table paper	A non-sterile sheet made of paper intended to cover the surface of an examination/treatment table, or chair, during use to function as a barrier between the table top and the patient to maintain hygienic conditions. It is typically supplied in a roll designed to be mounted at one end of the table such that a new length of paper can be pulled down over the table top for each new patient. 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	00810077210765	GS1
Primary	00647679163003	GS1

Customer Contacts

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