Esteem® Laser Light Guide 701720-002

GUDID 00812282020535

Laser Light Guide, Single Use

Envoy Medical Corporation

Fully-implantable middle ear implant system

• Primary Device ID: 00812282020535
• NIH Device Record Key: ed051466-ca17-4a05-b80a-2366cf988628
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Esteem® Laser Light Guide
• Version Model Number: 1720
• Catalog Number: 701720-002
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 651-361-8000
• Email: info@envoymedical.com
• Phone: 651-361-8000
• Email: info@envoymedical.com

Device Dimensions

• Outer Diameter: 0.76 Millimeter
• Outer Diameter: 0.76 Millimeter
• Outer Diameter: 0.76 Millimeter
• Outer Diameter: 0.76 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812282020535 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-24

On-Brand Devices [Esteem® Laser Light Guide]

• 00812282020573: Laser Light Guide, 5X Resterilizable
• 00812282020535: Laser Light Guide, Single Use