C.I.™

Basic Information

• Brand Name: C.I.™
• Primary DI: 10810000526397
• Version / Model: S119
• Catalog Number: S119
• Company Name: PARKELL, INC.
• Labeler DUNS: 009900424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2019-04-05
• Public Version: 2
• Public Version Date: 2023-12-21
• Public Version Status: Update
• Public Device Record Key: 1b2a89d9-8e84-47ee-815e-9f776d842013

Device Description

Medium #3 C.I.™ Stainless Steel Post Refill (Pkg. of 20 Posts & 1- Medium ‘C’ Drill)

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: No
• PM Exempt: Yes
• 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
ELR	Post, Root Canal	Dental	872.3810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38609	Root canal post, preformed	A prefabricated endodontic rod designed for insertion into the root canal of a patient to support and retain a crown prosthesis. It is typically a solid, cylindrical, metal (e.g., stainless steel, gold alloy) piece with a proximal end appropriate to support the crown on top; it is, however, available in a variety of shapes, dimensions, and materials (e.g., ceramics, fibre-reinforced polymers). In addition, it is available in a variety of types (e.g., non-threaded, pre-threaded, or self-tapping; straight or tapered). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10810000526397	GS1
Unit of Use	00810000526390	GS1

Customer Contacts

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