Foramatron®

Basic Information

• Brand Name: Foramatron®
• Primary DI: 00810000520220
• Version / Model: D611
• Catalog Number: D611
• Company Name: PARKELL, INC.
• Labeler DUNS: 009900424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-16
• Public Version: 1
• Public Version Date: 2018-12-17
• Public Version Status: New
• Public Device Record Key: ba565c70-2dcc-4b3b-8bd9-6a17a1a8cfad

Device Description

Touch-Proof Wire Assembly for Model D-10 Foramatron® (Includes: Lip Clips, Quick Test Probe Reamer Holder & Touch-Proof Wire)

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
LQY	Locator, Root Apex	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
16355	Endodontic apex locator	A dental instrument, using electricity, designed to locate the top of the root canal during endodontic procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810000520220	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]