Nucleus

Basic Information

• Brand Name: Nucleus
• Primary DI: 09321502002790
• Version / Model: Z60006
• Catalog Number: Z60006
• 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: 2018-12-24
• Public Version Status: Update
• Public Device Record Key: a2cb403a-4c47-4f00-9355-7aa665bf1194

Device Description

Cochlear Nucleus Depth Gauge (Straight)

Device Characteristics

• Single Use: Yes
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MCM	IMPLANT, COCHLEAR	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
46479	Surgical implant template, reusable	A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502002790	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P970051	048

Storage Conditions

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