INVASIVE ACCESSORIES AND INSTRUMENTS

Basic Information

• Brand Name: INVASIVE ACCESSORIES AND INSTRUMENTS
• Primary DI: 08059224084756
• Version / Model: ESTRATTORE IMP. NobelActive RP ø 4,3
• Catalog Number: 680NAC39
• Company Name: RHEIN 83 SRL
• Labeler DUNS: 439240722
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-08
• Public Version: 1
• Public Version Date: 2022-07-18
• Public Version Status: New
• Public Device Record Key: eb00fde9-6e9a-4aab-a912-b1232dfb0ad0

Device Description

Burs used to remove broken screws from the internal thread of the implant.

Device Characteristics

• Single Use: No
• 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: 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZA	Drill, Dental, Intraoral	Dental	872.4130	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64627	Dental implant holding endpiece	A device intended to hold a dental implant (e.g., orthodontic implant screw) at its distal end during the application of the implant to the patient’s oral cavity. It is typically a small metal shaft designed to be mounted onto the distal end of a manual screwdriver or slow-speed power tool whereby rotation is applied to introduce the implant into a surgical cavity. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08059224084756	GS1