MAP SYSTEM, INTRO KIT

Basic Information

• Brand Name: MAP SYSTEM, INTRO KIT
• Primary DI: 07640159160304
• Version / Model: 20285
• Company Name: Produits dentaires S.A.
• Labeler DUNS: 480420090
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-21
• Public Version: 1
• Public Version Date: 2022-06-29
• Public Version Status: New
• Public Device Record Key: 72a20710-07f1-4bb6-a37f-fce75d4f41da

Device Description

1 sterilisable aluminium case 185x95x30mm 1 Stainless steel syringe 1 Niti Memory shape Needle N°1 Red + N°0 Yellow + N°2 Blue 8 spare POM plungers N°1 Red + N°0 Yellow + N°2 Blue 1 Niti cleaning curette N°1 Red + N°0 Yellow + N°2 Blue 1 paste cleaing device stops N°1 Red + N°0 Yellow + N°2 Blue 1 Stainless steel weel diam 14mm

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: 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKI	Carrier, Amalgam, Operative	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35696	Dental amalgam carrier	A hand-held dental instrument specially designed to collect, transport and deposit amalgam in its plastic state into prepared cavities. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640159160304	GS1

Customer Contacts

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