SEPTALLOY BULK - 1 SPIL

Basic Information

• Brand Name: SEPTALLOY BULK - 1 SPIL
• Primary DI: 03760140703311
• Version / Model: 01C1525
• Catalog Number: 01C1525
• Company Name: SEPTODONT SAS SPECIALITES SEPTODONT
• Labeler DUNS: 275273795
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 345a9091-d1d5-4f81-a2f7-423af33be2bf

Device Description

Dental amalgam

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
EJJ	Alloy, Amalgam	Dental	872.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35791	Dental amalgam capsule	A small container in which silver (Ag) alloy is intended to be mixed with mercury (Hg) to form dental amalgam. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760140703311	GS1

Customer Contacts

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