OVC3 One Visit Crown

Basic Information

• Brand Name: OVC3 One Visit Crown
• Primary DI: 09421031795634
• Version / Model: SS Hex Stick Pack
• Catalog Number: 09421031795634
• Company Name: RHONDIUM LIMITED
• Labeler DUNS: 595078345
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-05
• Public Version: 1
• Public Version Date: 2019-01-07
• Public Version Status: New
• Public Device Record Key: 095f46e1-b020-4c97-a179-3a1066ceb75e

Device Description

Package contains x2 stainless steel hex sticks and x1 Instructions for Use (IFU)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
45008	Dental matrix band tensioner	A hand-held, dental instrument designed for tightening a matrix band around a tooth that is being prepared for a dental restoration. It is a rod-like device, typically designed with a manually controlled rotating action at its distal end for insertion into and tightening of a retainerless matrix band around the tooth. When the matrix band is in place, this device is removed offering a clear field of vision. Some types may incorporate a torque control mechanism to limit over-tensioning. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09421031795634	GS1

Customer Contacts

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