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Esteem® Ear Insert Assembly

FDA UDI

Class III (US FDA UDI)

by Envoy Medical Corporation

Identity

Trade Name
Esteem® Ear Insert Assembly FDA UDI
Generic Name
Fully-implantable middle ear implant system FDA UDI
Device Name
Sterile Ear Insert Assembly, Medium (13.7mm Foam) FDA UDI
Model / Reference
1200 FDA UDI
Description
Sterile Ear Insert Assembly, Medium (13.7mm Foam) FDA UDI

Identifiers

Catalog Number
901200-011 FDA UDI
Primary DI / UDI-DI
00812282020337 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

No

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

Dimensions & Sizes

Size
Outer Diameter — 13.7 Millimeter FDA UDI

Category: Fully-implantable middle ear implant system

Esteem® Ear Insert Assembly 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 165c98ec-dc64-40f4-8d9a-a98790f4885f 37 fields · synced May 30, 2026