Monoject

Basic Information

• Brand Name: Monoject
• Primary DI: 10884521195547
• Version / Model: 1180327114E
• Catalog Number: 1180327114E
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-22
• Public Version: 2
• Public Version Date: 2019-02-15
• Public Version Status: Update
• Public Device Record Key: 6165be05-7197-42b8-a3e0-bd6761e6850e

Device Description

Endodontic Irrigation Syringe with Needle

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: 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
12740	Dental syringe needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument with an integral hub, typically intended to be attached to a dental cartridge syringe for the injection of local anaesthetics. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521195544	GS1	PACK_OR_INNER_PACK	100	In Commercial Distribution
Primary	10884521195547	GS1
Package	30884521195541	GS1	CASE	800	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	1.25	Inch
Device Size Text, specify			Needle Gauge,27,Gauge;

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry