SAFETY PLUS HANDLES

Basic Information

• Brand Name: SAFETY PLUS HANDLES
• Primary DI: 03760140703151
• Version / Model: 01N3000
• Catalog Number: 01N3000
• 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: 5
• Public Version Date: 2019-11-15
• Public Version Status: Update
• Public Device Record Key: bfa912ec-1f1c-4bf8-bad3-16cbd51d4104

Device Description

Sterisable Black Handle for Needle

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: 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: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Dry Heat Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJI	Syringe, Cartridge	Dental	872.6770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35969	Dental anaesthesia syringe, reusable	A hand-held manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle; a needle is not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760140703151	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 30 Degrees Celsius