BURKHART DENTAL

Basic Information

• Brand Name: BURKHART DENTAL
• Primary DI: 00840018604339
• Version / Model: S314/BH
• Company Name: NORDENT MANUFACTURING INC
• Labeler DUNS: 053187985
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-21
• Public Version: 1
• Public Version Date: 2020-05-29
• Public Version Status: New
• Public Device Record Key: cb263bc2-3d00-4492-9867-6a35c83f38de

Device Description

BDS SCIS LAGARANGE 4 1/2 115MM 1BL SERRA

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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EGN	Scissors, Surgical Tissue, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31822	Dental surgical scissors	A hand-held dental instrument used to cut oral tissue during a dental surgical procedure. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and has blades that terminate in sharp, fine, points. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840018604339	GS1