Identity
- Trade Name
- Esteem® Sterile Drape FDA UDI
- Generic Name
- Fully-implantable middle ear implant system FDA UDI
- Device Name
- Sterile Drape FDA UDI
- Model / Reference
- 1300 FDA UDI
- Description
- Sterile Drape FDA UDI
Identifiers
- Catalog Number
- 701300-002 FDA UDI
- Primary DI / UDI-DI
- 00812282020528 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
MR Unsafe FDA UDI
Category: Fully-implantable middle ear implant system
Esteem® Sterile Drape 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.
- Esteem® Intraoperative System Analyzer — ENVOY MEDICAL CORPORATION · Class III
- Esteem® Transducer Replica — ENVOY MEDICAL CORPORATION · Class III
- Esteem® Sensor Replica — ENVOY MEDICAL CORPORATION · Class III
- Esteem® Intraoperative System Analyzer — ENVOY MEDICAL CORPORATION · Class III
- Esteem® Commander™ — ENVOY MEDICAL CORPORATION · Class III
- Esteem® Transducer Replica — ENVOY MEDICAL CORPORATION · Class III
- Esteem® Subdural Needle Electrode — ENVOY MEDICAL CORPORATION · Class III
- Esteem® Intraoperative System Analyzer — ENVOY MEDICAL CORPORATION · Class III
Cleared under the same submission
P090018 also covers:
- Esteem Intraoperative System Analyzer — ENVOY MEDICAL CORPORATION
- Esteem MedCem — ENVOY MEDICAL CORPORATION
- Esteem® Bone Screws — ENVOY MEDICAL CORPORATION
- Esteem® Bone Screws — ENVOY MEDICAL CORPORATION
- Esteem® Commander™ — ENVOY MEDICAL CORPORATION
- Esteem® Commander™ — ENVOY MEDICAL CORPORATION
- Esteem® Commander™ — ENVOY MEDICAL CORPORATION
- Esteem® Commander™ — ENVOY MEDICAL CORPORATION
- Esteem® Driver — ENVOY MEDICAL CORPORATION
- Esteem® Driver — ENVOY MEDICAL CORPORATION
- Esteem® Driver — ENVOY MEDICAL CORPORATION
- Esteem® Driver Replica — ENVOY MEDICAL CORPORATION
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Envoy Medical Corporation
Sources (1)
- FDA UDI 906c3a8b-bf54-4eec-b845-0051c4b6098a 36 fields · synced Jun 8, 2026