EUVAC

Basic Information

• Brand Name: EUVAC
• Primary DI: D8328028A1
• Version / Model: 8028-A
• Catalog Number: 8028-A
• Company Name: PLASDENT CORPORATION
• Labeler DUNS: 190377184
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2022-01-06
• Public Version: 1
• Public Version Date: 2022-01-14
• Public Version Status: New
• Public Device Record Key: 29218448-d1f7-4386-bd73-a935b881064b

Device Description

EUVAC Oral Evacuators, Assorted

Device Characteristics

• Single Use: No
• 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: Yes
• 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
EHZ	Evacuator, Oral Cavity	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38759	Dental suction system cannula, reusable	A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is made of metal or plastic materials that can be sterilized. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D8328028A0	HIBCC
Primary	D8328028A1	HIBCC