Nucleus

Basic Information

• Brand Name: Nucleus
• Primary DI: 09321502002325
• Version / Model: Z43004
• Catalog Number: Z43004
• 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: 3
• Public Version Date: 2018-12-24
• Public Version Status: Update
• Public Device Record Key: ae455b49-38ce-4d8c-ae93-f4ab7bf80dfa

Device Description

ABI 24M

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Expiration Date: Yes
• 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
47371	Auditory brainstem implant system electrode array assembly	The sterile implantable portion of an auditory brainstem implant system that typically consists of a battery-powered receiver-stimulator and an electrode array surgically placed on the brainstem's cochlear nucleus. The external portion of the device transmits electrical signals to the receiver-stimulator where they are decoded and sent to the multichannel electrode array to stimulate the brainstem's cochlear nucleus; this results in the signal's transmission to the brain where it is interpreted as sound.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502002325	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P000015	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 75 Percent (%) Relative Humidity