MARK3

Basic Information

• Brand Name: MARK3
• Primary DI: D79614040
• Version / Model: 1404
• Company Name: CARGUS INTERNATIONAL, INC
• Labeler DUNS: 096191093
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-27
• Public Version: 1
• Public Version Date: 2021-05-05
• Public Version Status: New
• Public Device Record Key: 019620f2-5e51-4fab-839f-aed546285782

Device Description

Headrest Covers Paper 10"x10" White 500/bx. - MARK3

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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
NRD	Unit, Operative Dental, Accessories	Dental	872.6640	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
Primary	D79614040	HIBCC

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in cool, dry place.