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Esteem® Intraoperative System Analyzer

FDA UDI

Class III (US FDA UDI)

by Envoy Medical Corporation

Identity

Trade Name
Esteem® Intraoperative System Analyzer FDA UDI
Generic Name
Fully-implantable middle ear implant system FDA UDI
Device Name
Intraoperative System Analyzer (ISA), Sterile Cable Pack FDA UDI
Model / Reference
3001 FDA UDI
Description
Intraoperative System Analyzer (ISA), Sterile Cable Pack FDA UDI

Identifiers

Catalog Number
903200-003 FDA UDI
Primary DI / UDI-DI
00812282020139 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Fully-implantable middle ear implant system

Esteem® Intraoperative System Analyzer 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 885a31f0-52c3-41ae-a8a6-ead52b688055 36 fields · synced Jun 1, 2026