Esteem® Sensor 907004-003

GUDID 00812282020054

Sensor Model 7004, IS-1 Connector

Envoy Medical Corporation

Fully-implantable middle ear implant system

• Primary Device ID: 00812282020054
• NIH Device Record Key: 0bf05887-0c3e-4eca-9c16-82ca6a5ac638
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Esteem® Sensor
• Version Model Number: 7004
• Catalog Number: 907004-003
• Company DUNS: 939725313
• Company Name: Envoy Medical Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6513618000
• Email: info@envoymedical.com
• Phone: 6513618000
• Email: info@envoymedical.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812282020054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P090018

FDA Product Code

• OAF: Implant, Hearing, Active, Middle Ear, Totally Implanted

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-21
• Device Publish Date: 2014-09-24

On-Brand Devices [Esteem® Sensor]

• 00812282020054: Sensor Model 7004, IS-1 Connector
• 00812282020047: Sensor Model 7004, IS-1 Connector
• 00812282020009: Sensor Model 7010, IS-1 Connector