Esteem Intraoperative System Analyzer 903200-002

GUDID 00812282020610

Model 3001 ISA, Sterile Cable Pack, Sensor/Driver-to-PID

Envoy Medical Corporation

Fully-implantable middle ear implant system
Primary Device ID00812282020610
NIH Device Record Keybb465ffa-310e-40e2-b002-fd04178dccb7
Commercial Distribution StatusIn Commercial Distribution
Brand NameEsteem Intraoperative System Analyzer
Version Model Number3200
Catalog Number903200-002
Company DUNS939725313
Company NameEnvoy Medical Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100812282020610 [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 Number2
Public Version Date2018-07-06
Device Publish Date2018-03-28

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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