M Acoustic Earhook Tool Kit

Basic Information

• Brand Name: M Acoustic Earhook Tool Kit
• Primary DI: 07630016883552
• Version / Model: CI-6148
• Company Name: Advanced Bionics AG
• Labeler DUNS: 485262658
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-08
• Public Version: 2
• Public Version Date: 2022-04-08
• Public Version Status: Update
• Public Device Record Key: 61bd7297-d422-49fa-b6a2-0676a137fdfc

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
62901	Cochlear implant/auditory brainstem implant sound processor speaker	A small device designed to be attached to the sound processor of a cochlear implant or auditory brainstem implant system and extended into the external ear canal to function as a speaker providing amplified acoustic low-frequency sound to the eardrum, as a conjunct to the electrical input to the implant. It is intended for patients with improvable low-frequency hearing and is typically made of synthetic polymer materials with metallic components. This is a single-patient, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07630016883552	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P960058	149