Burkhart Dental Supply

Basic Information

• Brand Name: Burkhart Dental Supply
• Primary DI: 00815878020780
• Version / Model: 72720639
• Company Name: BURKHART DENTAL SUPPLY CO., THE
• Labeler DUNS: 027532357
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2020-08-01
• Public Version: 1
• Public Version Date: 2020-08-10
• Public Version Status: New
• Public Device Record Key: 40a9f78d-9b5e-4739-835b-e98856838123

Device Description

Combo Tip High Volume Evacuator (50)

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: 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
37434	Dental suction system cannula, single-use	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 typically made of disposable plastic materials. 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	00815878020797	GS1
Primary	00815878020780	GS1

Customer Contacts

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