Esteem MedCem 901610-301

GUDID 00812282020603

MedCem Hydroxyapatite Cement

Envoy Medical Corporation

Fully-implantable middle ear implant system Fully-implantable middle ear implant system
Primary Device ID00812282020603
NIH Device Record Key4d5e1138-cf6f-482d-8c3a-1171f91c1464
Commercial Distribution StatusIn Commercial Distribution
Brand NameEsteem MedCem
Version Model Number1610
Catalog Number901610-301
Company DUNS939725313
Company NameEnvoy Medical Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100812282020603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OAFImplant, Hearing, Active, Middle Ear, Totally Implanted

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-17
Device Publish Date2018-07-17

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

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