MARK3

Basic Information

• Brand Name: MARK3
• Primary DI: D7962431
• Version / Model: 243-100
• Catalog Number: 243-100
• Company Name: CARGUS INTERNATIONAL, INC
• Labeler DUNS: 096191093
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-01-14
• Public Version: 2
• Public Version Date: 2022-11-21
• Public Version Status: Update
• Public Device Record Key: b0bf5927-56cf-4b93-bc94-511b58559a35

Device Description

105 Degree Prophy Angles Disposable Firm 100/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: No
• 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
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46938	Dental polishing cup, single-use	A rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. 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	D796243	HIBCC
Primary	D7962431	HIBCC

Customer Contacts

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