AquaMic™3D

Basic Information

• Brand Name: AquaMic™3D
• Primary DI: 07630016857973
• Version / Model: CI-5317
• Company Name: Advanced Bionics AG
• Labeler DUNS: 485262658
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-02
• Public Version: 5
• Public Version Date: 2024-02-22
• Public Version Status: Update
• Public Device Record Key: 43d4bb5f-e931-4315-8fb2-1d8104222c07
• Distribution End Date: 2024-05-26

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
58184	Cochlear implant/auditory brainstem implant coil	An external component of a cochlear implant (CI) or auditory brainstem implant system designed to transmit the electrical signals generated by the sound processor to the implantable receiver-stimulator and electrode array assembly (none included) of the hearing implant for the partial restoration of auditory sensation in a severely/profoundly deaf person. It is typically a round-shaped device with a magnet in its centre to magnetically couple with the implantable receiver-stimulator.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07630016857973	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P960058	129

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity