Coffret DENTOCLIC Fibre de verre

Basic Information

• Brand Name: Coffret DENTOCLIC Fibre de verre
• Primary DI: 03760260225014
• Version / Model: Coffret translucide
• Catalog Number: KFVT20
• Company Name: ITENA CLINICAL
• Labeler DUNS: 278261221
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-13
• Public Version: 1
• Public Version Date: 2023-01-23
• Public Version Status: New
• Public Device Record Key: aa35a944-4171-43af-abb8-23385553491d

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
ELR	Post, Root Canal	Dental	872.3810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16701	Dental restoration retention pin kit	A collection of various dental instruments, devices and materials intended for the insertion of permanent pins in healthy dentin to provide retention and/or stabilization of dental restorations such as fillings and crowns. It is typically presented as a kit and contains, e.g., retention pins of incrementing sizes, a selection of dental drills, and the necessary instruments to facilitate the procedure. This is a reusable device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760260225014	GS1