Darby Dental Supply, LLC

Basic Information

• Brand Name: Darby Dental Supply, LLC
• Primary DI: 00889813046302
• Version / Model: 9510417
• Catalog Number: 9510417
• Company Name: DARBY DENTAL SUPPLY, LLC
• Labeler DUNS: 825137818
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 85
• Record Status: Published
• Publish Date: 2020-07-02
• Public Version: 1
• Public Version Date: 2020-07-10
• Public Version Status: New
• Public Device Record Key: e531488f-e3c9-40c3-adfa-7843a24ca5a3

Device Description

F & P DISC REFILL 1/2 X-FINE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EHJ	DISK, ABRASIVE	Dental	872.6010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35807	Dental abrasive disk, reusable	A dental instrument consisting of a circular flat or slightly conical sheet carrying or containing an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations. It is designed to be fixed at its centre to a mandrel and intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). 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	00889813046296	GS1
Primary	00889813046302	GS1

Customer Contacts

• Phone: [phone] ext. 6431
• Email: [email protected]