MOOSER SYSTEM Integral Set

Basic Information

• Brand Name: MOOSER SYSTEM Integral Set
• Primary DI: J003C0202010000001
• Version / Model: C020201000000
• Catalog Number: C020201000000
• Company Name: MAILLEFER INSTRUMENTS HOLDING Sàrl
• Labeler DUNS: 480538495
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-30
• Public Version: 2
• Public Version Date: 2024-01-24
• Public Version Status: Update
• Public Device Record Key: 4409c914-cb0d-4081-84a4-cf97b0025490
• Distribution End Date: 2023-06-30

Device Description

Post system

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: 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
ELR	POST, ROOT CANAL	Dental	872.3810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45650	Root canal post kit	A collection of dental devices intended for use during insertion of a root canal post(s), sometimes with core build-up. This device typically includes a prefabricated root canal post(s), drill(s), thread cutter, and may include core-build-up materials such as applicator (dispensing gun), dental composite resin(s), dentine bonding agent, and etching solution. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J003C0202010000001	HIBCC

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: N/A