Darby Dental Supply, LLC

Basic Information

• Brand Name: Darby Dental Supply, LLC
• Primary DI: 00889813051535
• Version / Model: 9517540
• Catalog Number: 9517540
• Company Name: DARBY DENTAL SUPPLY, LLC
• Labeler DUNS: 825137818
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2021-02-19
• Public Version: 1
• Public Version Date: 2021-03-01
• Public Version Status: New
• Public Device Record Key: 6a340b27-33d5-40ff-bde5-78bc2537632b

Device Description

ABSORB PTS STRIP PAK 40X5 #60

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKN	POINT, PAPER, ENDODONTIC	Dental	872.3830	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38777	Endodontic paper point	A non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. 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	00889813049914	GS1
Primary	00889813051535	GS1

Customer Contacts

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