Darby Dental Supply, LLC

Basic Information

• Brand Name: Darby Dental Supply, LLC
• Primary DI: 00889813036945
• Version / Model: 9430328
• Catalog Number: 9430328
• Company Name: DARBY DENTAL SUPPLY, LLC
• Labeler DUNS: 825137818
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-26
• Public Version: 1
• Public Version Date: 2020-06-03
• Public Version Status: New
• Public Device Record Key: 1ced7733-b484-4383-ad2a-a834e201cfed

Device Description

CEMENT SPATULA #5 DOUBLE END

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: 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
GAF	SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35830	Salivary gland dilator, reusable	A surgical instrument used during ear/nose/throat (ENT) surgery for enlarging a salivary gland cavity, canal, or duct, typically prior to the introduction of a catheter during an invasive diagnostic or interventional procedure. It is rod-like device, with a long, very slender body and a rounded nose at its distal end, that is made of metal (e.g., stainless steel). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889813036945	GS1

Customer Contacts

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