Esteem® Intraoperative System Analyzer 004652-005

GUDID 00812282020429

Intraoperative System Analyzer (ISA), Software Version 9.0

Envoy Medical Corporation

Fully-implantable middle ear implant system Fully-implantable middle ear implant system
Primary Device ID00812282020429
NIH Device Record Keye93f341a-a338-41b8-88b7-1167a98ebce3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEsteem® Intraoperative System Analyzer
Version Model Number3001
Catalog Number004652-005
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone651-361-8000
Emailinfo@envoymedical.com
Phone651-361-8000
Emailinfo@envoymedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100812282020429 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OAFImplant, Hearing, Active, Middle Ear, Totally Implanted

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

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

On-Brand Devices [Esteem® Intraoperative System Analyzer]

00812282020474Intraoperative System Analyzer (ISA), Sterile Cable, PID to Speaker
00812282020467Intraoperative System Analyzer (ISA), Sterile Cable, PID to Speaker
00812282020450Intraoperative System Analyzer (ISA), Sterile Cable, PID to Microphone
00812282020443Intraoperative System Analyzer (ISA), Sterile Cable, PID to Driver
00812282020436Intraoperative System Analyzer (ISA), Sterile Cable, PID to Sensor
00812282020429Intraoperative System Analyzer (ISA), Software Version 9.0
00812282020191Intraoperative System Analyzer (ISA), Microphone with Barb
00812282020184Intraoperative System Analyzer (ISA), Cables and Accessories
00812282020177Intraoperative System Analyzer (ISA), Patient Interface Device
00812282020160Intraoperative System Analyzer (ISA), Software and Computer
00812282020146Intraoperative System Analyzer (ISA), Sterile Cable Pack
00812282020139Intraoperative System Analyzer (ISA), Sterile Cable Pack

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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