Coe®

FDA UDI

Class I (US FDA UDI)

by Gc America Inc.

Identity

Trade Name: COE® FDA UDI
Generic Name: Dental impression tray, reusable FDA UDI
Device Name: COE® McGowan-Winkler Complte Denture-Perforated Individual #89 Lower FDA UDI
Model / Reference: 260891 FDA UDI
Description: COE® McGowan-Winkler Complte Denture-Perforated Individual #89 Lower FDA UDI

Identifiers

Catalog Number: 260891 FDA UDI
Primary DI / UDI-DI: 10386040012270 FDA UDI
FDA Product Code: EBH FDA UDI
GMDN Term: Dental impression tray, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3670 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental impression tray, reusable

Coe® by Gc America Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Gc America Inc.

Sources (1)

FDA UDI e75346e2-3d8e-45d8-8e62-8aed9b6ab99e 35 fields · synced May 31, 2026