Nucleus

Basic Information

• Brand Name: Nucleus
• Primary DI: 09321502027632
• Version / Model: FUZ1005
• Catalog Number: FUZ1005
• Company Name: COCHLEAR LIMITED
• Labeler DUNS: 750551194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 4
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: 1f79ca71-a924-4c82-9093-3cde11600640

Device Description

NUCLEUS CR120 INTRAOPERATIVE REMOTE ASSISTANT KIT

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
57885	Hearing aid/implant system remote control	A battery-powered device designed to be operated by the wearer of a hearing aid or a hearing implant system to enable discreet wireless (remote) adjustments to the device (e.g., volume and program changes). It is designed to be conveniently portable (e.g., carried in a pocket, handbag, or attached to a key ring).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502027632	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P970051	096