Dentapen Protective Sleeve

Basic Information

• Brand Name: Dentapen Protective Sleeve
• Primary DI: EJUVPS021
• Version / Model: Dentapen Protective Sleeve
• Catalog Number: PS02
• Company Name: JUVAPLUS SA
• Labeler DUNS: 486026102
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2019-09-30
• Public Version: 1
• Public Version Date: 2019-10-08
• Public Version Status: New
• Public Device Record Key: 623f2668-d894-4d60-b86d-cbe61fd3567c

Device Description

Protective Sleeve for Dentapen

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
Primary	EJUVPS021	HIBCC
Unit of Use	EJUVPS02	HIBCC

Customer Contacts

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