PASTINJECT

Basic Information

• Brand Name: PASTINJECT
• Primary DI: J015201210191
• Version / Model: n35 L25
• Catalog Number: 20121019
• Company Name: MICRO MEGA
• Labeler DUNS: 276075371
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2020-08-28
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 6db4f5b6-7cee-43d4-a635-004735638c8d

Device Description

Endodontic instrument for professionnal dental use only

Device Characteristics

• Single Use: Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
EIY	Instrument, Filling, Plastic, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63622	Endodontic obturation material distribution endpiece, single-use	A dental endpiece designed to be attached to a dental power tool handpiece to distribute root canal sealer/cement/paste evenly throughout the root canal system typically by applying the material in a lateral direction. It is a thin metal rod with a spiral (e.g., Lentulo spiral type), helicoidal, or circular design. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	J015201210199	HIBCC	Box	10	In Commercial Distribution
Primary	J015201210191	HIBCC
Unit of Use	J015201210190	HIBCC