Cochlear™ Earmould Adaptor

Basic Information

• Brand Name: Cochlear™ Earmould Adaptor
• Primary DI: 09321502035231
• Version / Model: Z544860
• Catalog Number: Z544860
• Company Name: COCHLEAR LIMITED
• Labeler DUNS: 750551194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2017-07-07
• Public Version: 5
• Public Version Date: 2022-04-08
• Public Version Status: Update
• Public Device Record Key: 51d3ea0f-b250-4a25-a60e-22582e2b7cdf

Device Description

N/A

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	09321502035231	GS1
Unit of Use	09321502042130	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P970051	151