MARK3

Basic Information

• Brand Name: MARK3
• Primary DI: D7961318BL1
• Version / Model: 1318BL
• Catalog Number: 1318BL
• Company Name: CARGUS INTERNATIONAL, INC
• Labeler DUNS: 096191093
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2023-08-01
• Public Version: 1
• Public Version Date: 2023-08-09
• Public Version Status: New
• Public Device Record Key: 540f4423-eb1c-4633-bfc2-a5db5929e6c8

Device Description

Premium Bibs Blue 3Ply 13" x 18" 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: 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
KHR	Absorber, Saliva, Paper	Dental	872.6050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33531	Saliva absorbent	A non-sterile device designed to absorb moisture from the oral cavity during a dental procedure. Also known as a saliva absorber, it can be in a variety of shapes and sizes and is typically made of paper, cotton, or polymeric web, and may have a high-absorbent core. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D7961318BL1	HIBCC
Unit of Use	D7961318BL0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]