Envoy Medical Corporation

Address:4875 White Bear Pkwy,White Bear Lake,MN,55110,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Implant, Hearing, Active, Middle Ear, Totally Implanted (OAF) (10)

Premarket Exempt

Clear

Esteem® Sensor - 00812282020009 Catalog Number : 907010-001

Device Description : Sensor Model 7010, IS-1 Connector

Device Class : 3

Duns Number: 939725313

Premarket Exempt : No

Product Code : OAF

Prescription Use : Yes

Device Count : 1

Esteem® Driver - 00812282020016 Catalog Number : 907504-001

Device Description : Driver Model 7504, IS-1 Connector

Device Class : 3

Duns Number: 939725313

Premarket Exempt : No

Product Code : OAF

Prescription Use : Yes

Device Count : 1

Esteem® Driver - 00812282020023 Catalog Number : 907504-003

Device Description : Driver Model 7504, IS-1 Connector

Device Class : 3

Duns Number: 939725313

Premarket Exempt : No

Product Code : OAF

Prescription Use : Yes

Device Count : 1

Esteem® Driver - 00812282020030 Catalog Number : 907510-001

Device Description : Driver Model 7510, IS-1 Connector

Device Class : 3

Duns Number: 939725313

Premarket Exempt : No

Product Code : OAF

Prescription Use : Yes

Device Count : 1

Esteem® Sensor - 00812282020047 Catalog Number : 907004-001

Device Description : Sensor Model 7004, IS-1 Connector

Device Class : 3

Duns Number: 939725313

Premarket Exempt : No

Product Code : OAF

Prescription Use : Yes

Device Count : 1

Esteem® Sensor - 00812282020054 Catalog Number : 907004-003

Device Description : Sensor Model 7004, IS-1 Connector

Device Class : 3

Duns Number: 939725313

Premarket Exempt : No

Product Code : OAF

Prescription Use : Yes

Device Count : 1

Esteem® Personal Programmer - 00812282020078 Catalog Number : 908001-101

Device Description : Personal Programmer Model 8001

Device Class : 3

Duns Number: 939725313

Premarket Exempt : No

Product Code : OAF

Prescription Use : Yes

Device Count : 1

Esteem® Commander™ - 00812282020122 Catalog Number : 906011-102

Device Description : Esteem® Commander™ Model 6001

Device Class : 3

Duns Number: 939725313

Premarket Exempt : No

Product Code : OAF

Prescription Use : Yes

Device Count : 1

Esteem® Intraoperative System Analyzer - 00812282020139 Catalog Number : 903200-003

Device Description : Intraoperative System Analyzer (ISA), Sterile Cable Pack

Device Class : 3

Duns Number: 939725313

Premarket Exempt : No

Product Code : OAF

Prescription Use : Yes

Device Count : 1

Esteem® Intraoperative System Analyzer - 00812282020146 Catalog Number : 903200-005

Device Description : Intraoperative System Analyzer (ISA), Sterile Cable Pack

Device Class : 3

Duns Number: 939725313

Premarket Exempt : No

Product Code : OAF

Prescription Use : Yes

Device Count : 1

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