Monoject

Basic Information

• Brand Name: Monoject
• Primary DI: 20884521195506
• Version / Model: 1180323114E
• Catalog Number: 1180323114E
• 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: fec5b1c4-aa3b-45b9-9889-1a0e692f3b63

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	30884521195503	GS1	CASE	800	In Commercial Distribution
Primary	20884521195506	GS1
Package	10884521195509	GS1	PACK_OR_INNER_PACK	100	In Commercial Distribution

Customer Contacts

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

Device Sizes

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

Storage Conditions

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