Nucleus

Basic Information

• Brand Name: Nucleus
• Primary DI: 09321502026895
• Version / Model: Z463269
• Catalog Number: Z463269
• 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: 60e97b90-024a-44eb-8ab2-60c037e7f1d3

Device Description

NUCLEUS AQUA COIL, 6CM

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: 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
61152	Cochlear implant system waterproof kit	A collection of non-sterile devices intended to be used with a cochlear implant system to protect the externally worn components in wet and/or rugged environments (e.g. for swimming, showering). The set typically consists of a sound processor case, waterproof microphone, and a connecting cable. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502026895	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P970051	114

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			6cm coil
Outer Diameter	6	Centimeter

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 15 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 15 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius