Mi1260 SONATA 2 FLEX28

Basic Information

• Brand Name: Mi1260 SONATA 2 FLEX28
• Primary DI: 09008737385453
• Version / Model: 38545
• Catalog Number: 38555
• Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
• Labeler DUNS: 300764032
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-15
• Public Version: 3
• Public Version Date: 2022-05-20
• Public Version Status: Update
• Public Device Record Key: d0b6fe58-618e-46e9-bf2f-6ba53c003fdb

Device Description

Cochlear Implant

Device Characteristics

• Single Use: Yes
• 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 Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
47373	Cochlear implant system electrode array assembly	The implantable portion of a cochlear implant system [cochlear implant (CI)] that typically consists of an electrically-powered electrode array surgically implanted in one cochlea, and a receiver-stimulator implanted in the skull near the ear and connected to the electrode array; it does not elute a drug. Electrical signals are transmitted from the external portion of the device to the receiver-stimulator and ultimately to the cochlea, via the electrode array, for the partial restoration of auditory sensation in a severely/profoundly deaf person. Dedicated implantation instruments may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09008737385453	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P000025	114
P000025	122

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -29 – 60 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -20.2 – 140 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.