COE®

Basic Information

• Brand Name: COE®
• Primary DI: 10386040012003
• Version / Model: 250096
• Catalog Number: 250096
• Company Name: Gc America Inc.
• Labeler DUNS: 005473608
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2022-07-07
• Public Version: 2
• Public Version Date: 2023-04-21
• Public Version Status: Update
• Public Device Record Key: 18a40a89-4b52-41df-a911-71b9103f7a9c
• Distribution End Date: 2023-04-20

Device Description

COE® SPACER TRAYS Perforated Assorted Package

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBH	MATERIAL, IMPRESSION TRAY, RESIN	Dental	872.3670	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16350	Dental impression tray, single-use	A horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20386040012000	GS1	Carton	6	Not in Commercial Distribution	2023-04-20
Primary	10386040012003	GS1
Package	40386040012004	GS1	Carton	36	Not in Commercial Distribution	2023-04-20
Unit of Use	00386040012006	GS1

Customer Contacts

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