SeptoPlus Mandrel Refill: 1 mandrel snap

Basic Information

• Brand Name: SeptoPlus Mandrel Refill: 1 mandrel snap
• Primary DI: 07897990328718
• Version / Model: 01C4031
• Catalog Number: 01C4031
• Company Name: SEPTODONT SAS SPECIALITES SEPTODONT
• Labeler DUNS: 275273795
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-19
• Public Version: 1
• Public Version Date: 2022-12-27
• Public Version Status: New
• Public Device Record Key: a2eb6eae-4dcf-4fba-b1e4-7299ec9618c3

Device Description

Mandrel for contra angle

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
EHJ	Disk, Abrasive	Dental	872.6010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35170	Dental mandrel	A slender, round, metal shaft designed to be used chairside to hold (locked into place) a rotating dental device, e.g., a grinding wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing. The mandrel will be placed into a dental handpiece that will rotate at high speed. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07897990328718	GS1