BioGreen

Basic Information

• Brand Name: BioGreen
• Primary DI: 00856402006078
• Version / Model: 3005101
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• Labeler DUNS: 014789663
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-30
• Public Version: 4
• Public Version Date: 2022-07-07
• Public Version Status: Update
• Public Device Record Key: 5e5ae6ad-d63a-45dc-a54a-ffd8e73f82a0

Device Description

BioGreen Micro-Applicator - Fine

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: 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
KXR	Applicator, Resin	Dental	872.3140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38792	Tracheostomy tube, non-reinforced, non-customized, reusable	A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856402006078	GS1