CICADA

Basic Information

• Brand Name: CICADA
• Primary DI: 06974456210761
• Version / Model: K
• Company Name: Foshan Cicada Dental Instrument Co., Ltd.
• Labeler DUNS: 529797591
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 60
• Record Status: Published
• Publish Date: 2024-08-10
• Public Version: 1
• Public Version Date: 2024-08-19
• Public Version Status: New
• Public Device Record Key: 1045065b-770d-4f2e-9874-c79725013be0

Device Description

Endo Files

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• 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
EMI	File, Bone, Surgical	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31878	Manual endodontic file/rasp, reusable	A hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as an endodontic reamer. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	86974456210767	GS1
Primary	06974456210761	GS1