Monoject

Basic Information

• Brand Name: Monoject
• Primary DI: 20192253037446
• Version / Model: 8881400058
• Catalog Number: 8881400058
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2026-04-02
• Public Version: 1
• Public Version Date: 2026-04-10
• Public Version Status: New
• Public Device Record Key: e1c768f6-2625-4eb7-a115-2787519dc70b

Device Description

Dental Needle Plastic Hub with Medical Insert 27 G Long x 1-1/4" (0.4 x 32 mm)

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
DZM	NEEDLE, DENTAL	Dental	872.4730	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	50192253037447	GS1	CASE	10	In Commercial Distribution
Primary	20192253037446	GS1
Unit of Use	10192253037449	GS1

Device Sizes

Type	Value	Unit	Text
Needle Gauge	27	Gauge
Length	1.25	Inch