CALAJECT

Basic Information

• Brand Name: CALAJECT
• Primary DI: 05713513000942
• Version / Model: 2118
• Company Name: Rønvig Dental Manufacturing A/S
• Labeler DUNS: 307549241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-28
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: d81d557f-0a97-4102-b52a-72ab69e3781e

Device Description

Computer-assisted dental injection syringe

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
EJI	Syringe, Cartridge	Dental	872.6770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60599	Dental computer assisted anaesthesia injection unit	A mains electricity (AC-powered) dental device intended to accurately administer a local anaesthetic agent within the oral cavity for improved analgesic localization and pain reduction. It is typically a bench-top unit with processing software, displays, and controls (e.g., foot-switch) intended to be used in conjunction with a dental anaesthesia cartridge, handpiece, and needle to form a complete computer assisted local anaesthetic delivery system. It is designed to measure and display fluid pressure variations at the needle tip to indicate needle location and aid anaesthetic agent injection; it may also measure fluid volumes and flow rates.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05713513000942	GS1

Customer Contacts

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