BURKHART DENTAL

Basic Information

• Brand Name: BURKHART DENTAL
• Primary DI: 00840018603752
• Version / Model: H103/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: 088583d2-fde0-487a-9b63-9e44947e664b

Device Description

BDS HEMO #103 KELLY STR 5.5" ECON

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
EMD	Hemostat, Surgical	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11791	Dressing/utility forceps, scissors-like, reusable	A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840018603752	GS1