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Coe-Rect™

FDA UDI

Class II (US FDA UDI)

by Gc America Inc.

Identity

Trade Name
COE-RECT™ FDA UDI
Generic Name
Denture reliner, hard FDA UDI
Device Name
COE-RECT™ 14mL repair liquid FDA UDI
Model / Reference
343092 FDA UDI
Description
COE-RECT™ 14mL repair liquid FDA UDI

Identifiers

Catalog Number
343092 FDA UDI
Primary DI / UDI-DI
10386040006934 FDA UDI
FDA Product Code
EBI FDA UDI
GMDN Term
Denture reliner, hard FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3760 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Denture reliner, hard

Coe-Rect™ by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Denture reliner, hard.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gc America Inc.

Sources (1)

  • FDA UDI df155e28-00f5-4ce6-b987-977af51b2f97 36 fields · synced Jun 8, 2026