Esteem® Intraoperative System Analyzer 903001-003

GUDID 00812282020160

Intraoperative System Analyzer (ISA), Software and Computer

Envoy Medical Corporation

Fully-implantable middle ear implant system

• Primary Device ID: 00812282020160
• NIH Device Record Key: 3f890af0-04f4-431a-b5e9-d4a2af5f2520
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Esteem® Intraoperative System Analyzer
• Version Model Number: 3001
• Catalog Number: 903001-003
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812282020160 [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® Intraoperative System Analyzer]

• 00812282020474: Intraoperative System Analyzer (ISA), Sterile Cable, PID to Speaker
• 00812282020467: Intraoperative System Analyzer (ISA), Sterile Cable, PID to Speaker
• 00812282020450: Intraoperative System Analyzer (ISA), Sterile Cable, PID to Microphone
• 00812282020443: Intraoperative System Analyzer (ISA), Sterile Cable, PID to Driver
• 00812282020436: Intraoperative System Analyzer (ISA), Sterile Cable, PID to Sensor
• 00812282020429: Intraoperative System Analyzer (ISA), Software Version 9.0
• 00812282020191: Intraoperative System Analyzer (ISA), Microphone with Barb
• 00812282020184: Intraoperative System Analyzer (ISA), Cables and Accessories
• 00812282020177: Intraoperative System Analyzer (ISA), Patient Interface Device
• 00812282020160: Intraoperative System Analyzer (ISA), Software and Computer
• 00812282020146: Intraoperative System Analyzer (ISA), Sterile Cable Pack
• 00812282020139: Intraoperative System Analyzer (ISA), Sterile Cable Pack