EnvoyCem® 901640-103

GUDID 00812282020375

EnvoyCem® Glass Ionmer Cement

Envoy Medical Corporation

Glass ionomer dental cement
Primary Device ID00812282020375
NIH Device Record Keyf98fba45-2d82-4031-a99d-f1750f6a5c02
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnvoyCem®
Version Model Number1640
Catalog Number901640-103
Company DUNS939725313
Company NameEnvoy Medical Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6513618000
Emailinfo@envoymedical.com
Phone6513618000
Emailinfo@envoymedical.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100812282020375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEACement, Ear, Nose And Throat

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-24

Devices Manufactured by Envoy Medical Corporation

00812282020009 - Esteem® Sensor2018-12-21 Sensor Model 7010, IS-1 Connector
00812282020016 - Esteem® Driver2018-12-21 Driver Model 7504, IS-1 Connector
00812282020023 - Esteem® Driver2018-12-21 Driver Model 7504, IS-1 Connector
00812282020030 - Esteem® Driver2018-12-21 Driver Model 7510, IS-1 Connector
00812282020047 - Esteem® Sensor2018-12-21 Sensor Model 7004, IS-1 Connector
00812282020054 - Esteem® Sensor2018-12-21 Sensor Model 7004, IS-1 Connector
00812282020207 - Esteem® Sound Processor2018-12-21 Sound Processor Model 2001, IS-1 Connector Ports
00812282020214 - Esteem® Sound Processor2018-12-21 Sound Processor Model 2001, IS-1 Connector Ports

Trademark Results [EnvoyCem]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENVOYCEM
ENVOYCEM
78525297 3349409 Live/Registered
ENVOY MEDICAL CORPORATION
2004-12-01

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