COE-FLO™ 134001

GUDID D6581340012

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

Gc America Inc.

Denture reliner, soft, professional
Primary Device IDD6581340012
NIH Device Record Key813877c7-791f-4ab7-9479-6d2a8dc8afd7
Commercial Distribution Discontinuation2020-03-06
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCOE-FLO™
Version Model Number134001
Catalog Number134001
Company DUNS005473608
Company NameGc America Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD6581340011 [Primary]
HIBCCD6581340012 [Package]
Contains: D6581340011
Package: Carton [12 Units]
Discontinued: 2018-05-01
Not in Commercial Distribution

FDA Product Code

ELWMATERIAL, IMPRESSION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-06
Device Publish Date2016-08-01

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