Cochlear™ Tamper Resistant Earhook

Basic Information

• Brand Name: Cochlear™ Tamper Resistant Earhook
• Primary DI: 09321502063647
• Version / Model: P1840434
• Catalog Number: P1840434
• Company Name: COCHLEAR LIMITED
• Labeler DUNS: 750551194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-29
• Public Version: 1
• Public Version Date: 2022-12-07
• Public Version Status: New
• Public Device Record Key: 20be6cde-d787-4955-b7a2-0a09a6583352

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: MR Unsafe
• 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
61243	Cochlear implant/auditory brainstem implant sound processor earhook	A small hook-shaped or formable device designed to be attached to the sound processor of a cochlear implant or auditory brainstem implant system to facilitate wearing behind the ear. It is typically made of synthetic polymer materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502063647	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P970051	211