Cochlear

Basic Information

• Brand Name: Cochlear
• Primary DI: 09321502046459
• Version / Model: P1624218
• Catalog Number: P1624218
• Company Name: COCHLEAR LIMITED
• Labeler DUNS: 750551194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2020-01-03
• Public Version: 2
• Public Version Date: 2022-04-08
• Public Version Status: Update
• Public Device Record Key: 74a58dee-9746-4474-90dc-b44be5dcbb9f

Device Description

CP1000 5 (I) MAGNET COVER (BLACK), PACKED

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: Yes
• 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
61381	Cochlear implant/auditory brainstem implant sound processor/coil decorative cover	A device intended to be used as an aesthetic (decorative) cover for the sound processor and/or coil (not included) of a cochlear implant (CI) or auditory brainstem implant system. It is typically made of plastic material (e.g., polystyrene) designed to be clipped onto the sound processor/coil; it is available in a variety of colours/designs. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502046459	GS1
Unit of Use	09321502051033	GS1

Customer Contacts

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