MRI Antenna Coil Cover

Basic Information

• Brand Name: MRI Antenna Coil Cover
• Primary DI: 00840094456051
• Version / Model: CI-7521
• Company Name: Advanced Bionics, LLC
• Labeler DUNS: 803906382
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-13
• Public Version: 1
• Public Version Date: 2023-01-23
• Public Version Status: New
• Public Device Record Key: d6e964bc-9ed6-4b96-83ab-30549b52f54f

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
63638	Cochlear implant implantable magnet MRI shield	A non-sterile device intended to secure the implantable magnet in the cochlear implant system in the presence of the magnetic field produced by a magnetic resonance imaging (MRI) system, to prevent displacement of the magnet during an MRI procedure. It is intended to be placed externally on the head of the patient directly over the implant, typically using a bandage(s) and/or tape(s); it is made of synthetic polymer materials (e.g., polycarbonate, polyester). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840094456051	GS1
Previous	07630016849503	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P960058	117