PROBEVAC

Basic Information

• Brand Name: PROBEVAC
• Primary DI: D832INTP231
• Version / Model: INT-P23
• Catalog Number: INT-P23
• Company Name: PLASDENT CORPORATION
• Labeler DUNS: 190377184
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2021-12-17
• Public Version: 1
• Public Version Date: 2021-12-27
• Public Version Status: New
• Public Device Record Key: 6dfa0667-c8e4-4245-b719-35321df2c0c7

Device Description

Probevac Irrigator Tips, 23ga, Blue, Close End, Max-I-Probe Style

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: No
• 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
64403	Root canal irrigation blunt needle	A slender, hollow, tubular, metal instrument with a blunt tip designed specifically for irrigation of the root canal of a tooth during an endodontic procedure. Sometimes referred to as a root canal irrigation cannula, it is typically attached to a dental syringe (not included) filled with a root canal cleaning solution. It might be bent or straight and might have either a side vented tip or a blunt open-ended tip. 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	D832INTP230	HIBCC
Primary	D832INTP231	HIBCC