MONOVAC

Basic Information

• Brand Name: MONOVAC
• Primary DI: D832INTSMPT03271
• Version / Model: INTS-MPT0327
• Catalog Number: INTS-MPT0327
• Company Name: PLASDENT CORPORATION
• Labeler DUNS: 190377184
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-10-09
• Public Version: 1
• Public Version Date: 2023-10-17
• Public Version Status: New
• Public Device Record Key: 33bdab47-87e9-445e-84a4-195abef7ca79

Device Description

Pre-Tipped Irrigator Syringe, 3cc, 27ga, Side Vented, Monoject Style, Sterile

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• 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
35390	Irrigation syringe	A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D832INTSMPT03270	HIBCC
Primary	D832INTSMPT03271	HIBCC