HiFocus MS Electrode Insertion Tool

GUDID 00840094406766

Advanced Bionics, LLC

Cochlear implant system, external-microphone

• Primary Device ID: 00840094406766
• NIH Device Record Key: c8798afc-e29b-46af-8d75-93750a4875e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HiFocus MS Electrode Insertion Tool
• Version Model Number: CI-4207
• 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: 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: +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

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
• 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	00840094406766 [Primary]
GS1	07630016831812 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960058

FDA Product Code

• MCM: Implant, cochlear

Sterilization

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

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

Devices Manufactured by Advanced Bionics, LLC

• 00840094404724 - RF Cable: 2026-03-19 9.5" Beige
• 00840094404762 - RF Cable: 2026-03-19 5.5" White
• 00840094404786 - RF Cable: 2026-03-19 12" White
• 00840094404793 - RF Cable: 2026-03-19 3.5" White
• 00840094404960 - RF Cable: 2026-03-19 5.5" Brown
• 07630016866395 - UHP 3D Color Cap: 2026-03-19 Sand Beige
• 07630016866401 - UHP 3D Color Cap: 2026-03-19 Chestnut
• 07630016866418 - UHP 3D Color Cap: 2026-03-19 Silver Gray