COE® 260431

GUDID 10386040002165

COE® McGowan-Winkler Denture-Perforated #43 Upper

Gc America Inc.

Dental impression tray, reusable
Primary Device ID10386040002165
NIH Device Record Key35a6f67c-c29b-4d28-a00a-3b91bb914807
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOE®
Version Model Number260431
Catalog Number260431
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
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110386040002165 [Primary]

FDA Product Code

EBHMATERIAL, IMPRESSION TRAY, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-15
Device Publish Date2022-07-07

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20386040012031COE® SPACER TRAYS #22D Small Lower Perforated
40386040012028COE® SPACER TRAYS #21D Medium Lower Perforated
20386040012017COE® SPACER TRAYS #20D Large Lower Perforated
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10386040002202COE® McGowan-Winkler Denture-Perforated #47 Lower
10386040002196COE® McGowan-Winkler Denture-Perforated #46 Lower
10386040002189COE® McGowan-Winkler Denture-Perforated #45 Lower
10386040002172COE® McGowan-Winkler Denture-Perforated #44 Upper
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