Esteem MedCem 901610-301

GUDID 00812282020603

MedCem Hydroxyapatite Cement

Envoy Medical Corporation

Fully-implantable middle ear implant system

• Primary Device ID: 00812282020603
• NIH Device Record Key: 4d5e1138-cf6f-482d-8c3a-1171f91c1464
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Esteem MedCem
• Version Model Number: 1610
• Catalog Number: 901610-301
• 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: true
• Lot Batch: true
• Serial Number: false
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812282020603 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-17
• Device Publish Date: 2018-07-17

Devices Manufactured by Envoy Medical Corporation

• 00812282020009 - Esteem® Sensor: 2018-12-21 Sensor Model 7010, IS-1 Connector
• 00812282020016 - Esteem® Driver: 2018-12-21 Driver Model 7504, IS-1 Connector
• 00812282020023 - Esteem® Driver: 2018-12-21 Driver Model 7504, IS-1 Connector
• 00812282020030 - Esteem® Driver: 2018-12-21 Driver Model 7510, IS-1 Connector
• 00812282020047 - Esteem® Sensor: 2018-12-21 Sensor Model 7004, IS-1 Connector
• 00812282020054 - Esteem® Sensor: 2018-12-21 Sensor Model 7004, IS-1 Connector
• 00812282020207 - Esteem® Sound Processor: 2018-12-21 Sound Processor Model 2001, IS-1 Connector Ports
• 00812282020214 - Esteem® Sound Processor: 2018-12-21 Sound Processor Model 2001, IS-1 Connector Ports