Monoject

Basic Information

• Brand Name: Monoject
• Primary DI: 40884521010438
• Version / Model: 8881471232
• Catalog Number: 8881471232
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2018-06-30
• Public Version: 2
• Public Version Date: 2019-02-15
• Public Version Status: Update
• Public Device Record Key: 8decbc59-dd80-4286-b10e-ac5f9fe8485a

Device Description

Endodontic Needle

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIC	SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35970	Dental irrigation/aspiration syringe	A hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30884521010431	GS1	PACK_OR_INNER_PACK	100	In Commercial Distribution
Primary	40884521010438	GS1
Package	20884521010434	GS1	CASE	2800	In Commercial Distribution
Unit of Use	50884521010435	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	1.25	Inch
Device Size Text, specify			Needle Gauge,23,Gauge;

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry;AVOID DIRECT SUNLIGHT