ROEKO Concorde II

Basic Information

• Brand Name: ROEKO Concorde II
• Primary DI: E16555370
• Version / Model: SAMPLE
• Catalog Number: 5537
• Company Name: Coltène/Whaledent GmbH + Co. KG
• Labeler DUNS: 315494443
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-23
• Public Version: 4
• Public Version Date: 2024-01-01
• Public Version Status: Update
• Public Device Record Key: 47f2c647-8615-4d8d-9302-185e3207617f
• Distribution End Date: 2023-12-31

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOL	Catheter And Tip, Suction	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38759	Dental suction system cannula, reusable	A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is made of metal or plastic materials that can be sterilized. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E16555370	HIBCC

Customer Contacts

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