Cochlear™ Hybrid™ Bass Double Dome, 10 mm

Basic Information

• Brand Name: Cochlear™ Hybrid™ Bass Double Dome, 10 mm
• Primary DI: 09321502038416
• Version / Model: Z545004
• Catalog Number: Z545004
• Company Name: COCHLEAR LIMITED
• Labeler DUNS: 750551194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-07-07
• Public Version: 4
• Public Version Date: 2021-08-30
• Public Version Status: Update
• Public Device Record Key: ba9f050c-d489-4a8b-b222-bd433eca5568

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
62259	Earmould, preformed	A preformed device designed to fit in an ear canal and through which the acoustic output from a hearing aid is conveyed to the eardrum. It is made of soft synthetic polymer materials and may have various forms (e.g., plug-like, ear shape). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502038416	GS1
Unit of Use	09321502043106	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P970051	151

Device Sizes

Type	Value	Unit	Text
Outer Diameter	10	Millimeter
Device Size Text, specify			10mm diameter dome