Darby Dental Supply, LLC

Basic Information

• Brand Name: Darby Dental Supply, LLC
• Primary DI: 00889813042007
• Version / Model: 9544404
• Catalog Number: 9544404
• Company Name: DARBY DENTAL SUPPLY, LLC
• Labeler DUNS: 825137818
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2022-05-12
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 852adfc3-f2b5-410d-9cb8-35f5f58a49ad

Device Description

FINGER SPREADER 21MM F

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
EKK	SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63622	Endodontic obturation material distribution endpiece, single-use	A dental endpiece designed to be attached to a dental power tool handpiece to distribute root canal sealer/cement/paste evenly throughout the root canal system typically by applying the material in a lateral direction. It is a thin metal rod with a spiral (e.g., Lentulo spiral type), helicoidal, or circular design. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00889813041994	GS1
Primary	00889813042007	GS1

Customer Contacts

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