Classic by RISKONTROL

Basic Information

• Brand Name: Classic by RISKONTROL
• Primary DI: 03760243000508
• Version / Model: RISKONTROL
• Catalog Number: 201665
• Company Name: PRODUITS DENTAIRES PIERRE ROLLAN
• Labeler DUNS: 277657631
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2022-09-20
• Public Version: 1
• Public Version Date: 2022-09-28
• Public Version Status: New
• Public Device Record Key: 7e29ec90-11f7-41d5-be39-eaf641f0200f

Device Description

Disposable single use tips for air/water syringe

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: 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
ECB	Unit, Syringe, Air And/Or Water	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
18033	Surgical mist irrigation tip	A device that is designed to deliver a combined stream of air and mist to clear blood from a specific area of a surgical site. This device is a special perforated tip which can be affixed to an appropriate kind of tubing that delivers the rinsing fluids. 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	03760243009921	GS1
Primary	03760243000508	GS1

Customer Contacts

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