Cochlear™ Magnet (1M White)

Basic Information

• Brand Name: Cochlear™ Magnet (1M White)
• Primary DI: 09321502036900
• Version / Model: Z586146
• Catalog Number: Z586146
• Company Name: COCHLEAR LIMITED
• Labeler DUNS: 750551194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-07
• Public Version: 7
• Public Version Date: 2023-07-27
• Public Version Status: Update
• Public Device Record Key: 1f78ab43-3b13-4ad9-994b-4ab2e931f619

Device Description

1M White

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: No
• 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: 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
62944	Hearing implant system external magnet	A small, magnetic device intended to hold in place the sound processor and/or coil (not included) of a hearing implant system (e.g., cochlear, auditory brainstem, bone-conduction, partially-implantable middle ear implant system), to the outside of the scalp, typically by coupling with an implanted magnet. It is typically a magnetized metal disc that is attached to the processor/coil, but may be supplied separately.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502036900	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P970051	151

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1 M strength magnet