Esteem® Commander™ 906011-102

GUDID 00812282020122

Esteem® Commander™ Model 6001

Envoy Medical Corporation

Fully-implantable middle ear implant system

• Primary Device ID: 00812282020122
• NIH Device Record Key: 381d2cf5-453e-44bf-9af4-fe43fd649eb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Esteem® Commander™
• Version Model Number: 6001
• Catalog Number: 906011-102
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Handle with Care
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Handle with Care

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812282020122 [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: false

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® Commander™]

• 00812282020504: Esteem® Commander™ Software Version 3.0
• 00812282020498: Esteem® Commander™ Model 6002
• 00812282020481: Esteem® Commander™ Software Version 2.2
• 00812282020122: Esteem® Commander™ Model 6001