Esteem® Sensor 907004-003

GUDID 00812282020054

Sensor Model 7004, IS-1 Connector

Envoy Medical Corporation

Fully-implantable middle ear implant system Fully-implantable middle ear implant system
Primary Device ID00812282020054
NIH Device Record Key0bf05887-0c3e-4eca-9c16-82ca6a5ac638
Commercial Distribution StatusIn Commercial Distribution
Brand NameEsteem® Sensor
Version Model Number7004
Catalog Number907004-003
Company DUNS939725313
Company NameEnvoy Medical Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
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
GS100812282020054 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-21
Device Publish Date2014-09-24

On-Brand Devices [Esteem® Sensor]

00812282020054Sensor Model 7004, IS-1 Connector
00812282020047Sensor Model 7004, IS-1 Connector
00812282020009Sensor Model 7010, IS-1 Connector

Trademark Results [Esteem]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ESTEEM
ESTEEM
98430061 not registered Live/Pending
Roger Coffey and Son Nursery, Inc.
2024-03-01
ESTEEM
ESTEEM
98367382 not registered Live/Pending
Blue Ridge Home Fashions, Inc.
2024-01-20
ESTEEM
ESTEEM
97920375 not registered Live/Pending
BODEGAS BORSAO, S.A.
2023-05-04
ESTEEM
ESTEEM
88859311 not registered Live/Pending
Kai U.S.A., Ltd.
2020-04-03
ESTEEM
ESTEEM
88243836 not registered Live/Pending
HORIZON FOREST PRODUCTS, L.P.
2018-12-28
ESTEEM
ESTEEM
87833702 5835616 Live/Registered
Esteem Model Co., Ltd.
2018-03-14
ESTEEM
ESTEEM
87568097 5571853 Live/Registered
Jayco, Inc.
2017-08-14
ESTEEM
ESTEEM
87299670 not registered Dead/Abandoned
Esteem Surf, Inc., a California corporation
2017-01-12
ESTEEM
ESTEEM
87283161 5551545 Live/Registered
Millennium Design Co. USA, Ltd.
2016-12-28
ESTEEM
ESTEEM
87144557 5180452 Live/Registered
Blue Ridge Home Fashions, Inc.
2016-08-19
ESTEEM
ESTEEM
86946628 5081022 Live/Registered
Esteem, Inc.
2016-03-21
ESTEEM
ESTEEM
86566666 not registered Dead/Abandoned
Esteem Model Co., Ltd.
2015-03-17

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