ROEKO GuttaFlow®2

Basic Information

• Brand Name: ROEKO GuttaFlow®2
• Primary DI: E165600137192
• Version / Model: 60013719
• Catalog Number: 60013719
• Company Name: Coltène/Whaledent GmbH + Co. KG
• Labeler DUNS: 315494443
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2022-09-22
• Public Version: 2
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: 74642a78-fba5-4182-be53-cb65d76467bb

Device Description

ROEKO GuttaFlow®2 Mixing tips

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: 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
DZN	Instruments, Dental Hand	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58399	Dental material mixing nozzle	A device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. 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	E165600137190	HIBCC
Primary	E165600137192	HIBCC

Customer Contacts

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