COE-RECT™

Basic Information

• Brand Name: COE-RECT™
• Primary DI: D6583430011
• Version / Model: 343001
• Catalog Number: 343001
• Company Name: Gc America Inc.
• Labeler DUNS: 005473608
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-01
• Public Version: 3
• Public Version Date: 2018-08-09
• Public Version Status: Update
• Public Device Record Key: b1b52deb-7b6d-4d66-b4ef-64fd73889e78

Device Description

COE-RECT™ Professional Package (1 x 6oz powder, 1 x 6oz liquid, 1 x 14mL repair liquid & accessories)

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBI	RESIN, DENTURE, RELINING, REPAIRING, REBASING	Dental	872.3760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17609	Denture reliner, hard	A denture relining material intended to be applied by a dentist or dental laboratory technician as a permanent coating or lining on the base or tissue-contact surface of a denture and which sets to a hard state. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D6583430011	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 70 – 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 21 – 25 Degrees Celsius