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Esteem® Driver Replica

FDA UDI

Class III (US FDA UDI)

by Envoy Medical Corporation

Identity

Trade Name
Esteem® Driver Replica FDA UDI
Generic Name
Fully-implantable middle ear implant system FDA UDI
Device Name
Surgical Replica of Model 7510 Driver FDA UDI
Model / Reference
1510 FDA UDI
Description
Surgical Replica of Model 7510 Driver FDA UDI

Identifiers

Catalog Number
005774-001 FDA UDI
Primary DI / UDI-DI
00812282020405 FDA UDI
PMA Number
P090018 FDA UDI
FDA Product Code
OAF FDA UDI
GMDN Term
Fully-implantable middle ear implant system FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Fully-implantable middle ear implant system

Esteem® Driver Replica by Envoy Medical Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fully-implantable middle ear implant system.

Cleared under the same submission

P090018 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Envoy Medical Corporation

Sources (1)

  • FDA UDI 8cfa106c-706a-4577-bc47-dad2842f338c 37 fields · synced Jun 7, 2026