Darby Dental Supply, LLC

Basic Information

• Brand Name: Darby Dental Supply, LLC
• Primary DI: 00889813051177
• Version / Model: 5251727
• Catalog Number: 5251727
• Company Name: DARBY DENTAL SUPPLY, LLC
• Labeler DUNS: 825137818
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2021-03-12
• Public Version: 1
• Public Version Date: 2021-03-22
• Public Version Status: New
• Public Device Record Key: 516877dc-1c53-49b2-be23-342e369646a3

Device Description

SWANGLE TURBO FIRM CUP

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: Yes
• 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: Yes
• 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
EKH	CARVER, DENTAL AMALGAM, OPERATIVE	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16184	Dental polishing cup, reusable	A rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. 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	00889813050859	GS1
Primary	00889813051177	GS1

Customer Contacts

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