Dentapen Cartridge holder

Basic Information

• Brand Name: Dentapen Cartridge holder
• Primary DI: EJUVDP057
• Version / Model: Cartridge hodler for Dentapen
• Catalog Number: DP05
• Company Name: JUVAPLUS SA
• Labeler DUNS: 486026102
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 7
• Record Status: Published
• Publish Date: 2018-10-22
• Public Version: 1
• Public Version Date: 2018-11-22
• Public Version Status: New
• Public Device Record Key: 029a8cc0-a303-451f-8722-0e4e7ca8be1b

Device Description

The non-sterile cartridge holder is used to connect the device to the cartridge. In order to ensure the quantity scale reading on the prefilled cartridge, the cartridge holder is transparent.

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: No
• Has Lot/Batch Number: Yes
• 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
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
Package	EJUVDP058	HIBCC	Caron box	5	In Commercial Distribution
Primary	EJUVDP057	HIBCC
Unit of Use	EJUVDP05	HIBCC

Customer Contacts

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