COE-FLO™

Basic Information

• Brand Name: COE-FLO™
• Primary DI: D6581340011
• Version / Model: 134001
• Catalog Number: 134001
• Company Name: Gc America Inc.
• Labeler DUNS: 005473608
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-01
• Public Version: 4
• Public Version Date: 2020-03-06
• Public Version Status: Update
• Public Device Record Key: 813877c7-791f-4ab7-9479-6d2a8dc8afd7
• Distribution End Date: 2020-03-06

Device Description

COE-FLO™ Standard Package (1 x 110g base, 1 x 115g catalyst)

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
ELW	MATERIAL, IMPRESSION	Dental	872.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17610	Denture reliner, soft, professional	A denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D6581340012	HIBCC	Carton	12	Not in Commercial Distribution	2018-05-01
Primary	D6581340011	HIBCC

Customer Contacts

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