HiRes™ Ultra Replacement Magnet

Basic Information

• Brand Name: HiRes™ Ultra Replacement Magnet
• Primary DI: 07630016860652
• Version / Model: CI-1413
• Company Name: Advanced Bionics AG
• Labeler DUNS: 485262658
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-23
• Public Version: 3
• Public Version Date: 2024-02-22
• Public Version Status: Update
• Public Device Record Key: ad275ba0-cbc9-4ed8-9fcb-718a2f45d8e2
• Distribution End Date: 2024-05-26

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MCM	Implant, Cochlear	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
62601	Cochlear implant implantable magnet	A small, sterile, magnetic device intended to be implanted subcutaneously within the implantable component of a cochlear implant system (CIS) and to couple with a magnet in the CIS external component, to hold implantable and external components in place. It is typically a magnetized metal disc contained within a non-reactive metal (e.g., titanium) case.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07630016860652	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P960058	117