Esteem® Sensor Replica 005773-001

GUDID 00812282020412

Surgical Replica of Model 7010 Sensor

Envoy Medical Corporation

Fully-implantable middle ear implant system

• Primary Device ID: 00812282020412
• NIH Device Record Key: 1043efa9-ac94-4d7d-bb0b-8c32d2d3fe1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Esteem® Sensor Replica
• Version Model Number: 1510
• Catalog Number: 005773-001
• Company DUNS: 939725313
• Company Name: Envoy Medical Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812282020412 [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: true
• Device Is Sterile: false

[00812282020412]

Moist Heat or Steam Sterilization

[00812282020412]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-24

On-Brand Devices [Esteem® Sensor Replica]

• 00812282020412: Surgical Replica of Model 7010 Sensor
• 00812282020399: Sensor Replica