SFI-Bar

Basic Information

• Brand Name: SFI-Bar
• Primary DI: 07640166510338
• Version / Model: 07000106
• Catalog Number: 07000106
• Company Name: Cendres+Métaux SA
• Labeler DUNS: 487506230
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-14
• Public Version: 2
• Public Version Date: 2021-06-14
• Public Version Status: Update
• Public Device Record Key: c57bc5e3-89f1-42ef-b129-39f69a267f7c

Device Description

0700 0106 Tube bar gauge For determining the exact length of the tube bar in the mouth. Can be used as a bracket while cutting.

Device Characteristics

• Single Use: No
• 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: 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
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64322	Dental precision attachment fitting/adjustment tool	A manual dental laboratory instrument intended to be used in a dental laboratory during fabrication or revision of a final dental prosthesis (e.g., denture, crown, bridge) to integrate and/or adjust the fitting between male and female precision attachments. It is in the form of a handle with a distal end designed to perform a dedicated function (e.g., facilitate the parallel placement of a male attachment, remove/exchange/adjust an attachment, insert a retention insert, tighten a screwable element of an attachment); some types may be heated to enable melting, or attached to a motorized handpiece (e.g., drill). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640166510338	GS1

Customer Contacts

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