HiFocus Mid-Scala Electrode Instrument Kit

GUDID 00840094456518

Advanced Bionics, LLC

Cochlear implant system, external-microphone

• Primary Device ID: 00840094456518
• NIH Device Record Key: 47464a68-2f1f-4599-92a1-28f1a45305ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HiFocus Mid-Scala Electrode Instrument Kit
• Version Model Number: CI-4508
• Company DUNS: 803906382
• Company Name: Advanced Bionics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840094456518 [Primary]
GS1	07630016815249 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960058

FDA Product Code

• MCM: Implant, cochlear

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840094456518]

Moist Heat or Steam Sterilization

[00840094456518]

Moist Heat or Steam Sterilization

[00840094456518]

Moist Heat or Steam Sterilization

[00840094456518]

Moist Heat or Steam Sterilization

[00840094456518]

Moist Heat or Steam Sterilization

[00840094456518]

Moist Heat or Steam Sterilization

[00840094456518]

Moist Heat or Steam Sterilization

[00840094456518]

Moist Heat or Steam Sterilization

[00840094456518]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-03-19
• Device Publish Date: 2022-12-09

On-Brand Devices [HiFocus Mid-Scala Electrode Instrument Kit]

• 00840094456518: CI-4508
• 00840094454569: CI-4508