Darby Dental Supply, LLC

Basic Information

• Brand Name: Darby Dental Supply, LLC
• Primary DI: 00889813064351
• Version / Model: 5257137
• Company Name: DARBY DENTAL SUPPLY, LLC
• Labeler DUNS: 825137818
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-30
• Public Version: 1
• Public Version Date: 2024-12-09
• Public Version Status: New
• Public Device Record Key: 590daf83-a810-4937-9e8d-2209e6a584e8

Device Description

RETRACTOR UNIV OF MINNESOTA

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIG	RETRACTOR, ALL TYPES	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58263	Vibrating dental retractor tip	A non-sterile dental device intended to be attached to a battery-powered vibrating dental retractor handpiece to function as the retraction hook and vibration transmitter during the administration of a dental injection. The vibration is intended to minimize the pain of the injection by distracting the patient. The device is rubber coated and hook-like to retract the lip/cheek and is simultaneously placed on the gum/palate close to the injection site to transmit the vibrations. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889813064351	GS1