IVeneer Injectable Matrix System

Basic Information

• Brand Name: IVeneer Injectable Matrix System
• Primary DI: 07290019259022
• Version / Model: Intro Kit 64 size S/M
• Catalog Number: IVES64
• Company Name: IVENEER LTD
• Labeler DUNS: 600811880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 64
• Record Status: Published
• Publish Date: 2024-10-21
• Public Version: 1
• Public Version Date: 2024-10-29
• Public Version Status: New
• Public Device Record Key: c442f835-127e-44d2-a162-500cc732fcd6

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JEP	Retainer, Matrix	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38786	Dental matrix band, single-use	A band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. 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	7290019259022	GS1
Primary	07290019259022	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Small Medium, Medium Large