SONNET 3 BabyWear Kit (DL) White

Basic Information

• Brand Name: SONNET 3 BabyWear Kit (DL) White
• Primary DI: 09008737383015
• Version / Model: 38301
• 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: 2025-02-27
• Public Version: 1
• Public Version Date: 2025-03-07
• Public Version Status: New
• Public Device Record Key: 0d60a9a6-7f1b-4658-a245-897ed3a5141d

Device Description

Audio Processor Accessory

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
62943	Cochlear implant system external kit	A collection of non-sterile devices intended to be given to a cochlear implant patient, typically after the first fitting, as a convenience kit of various external components of a cochlear implant system. It typically includes a cochlear implant sound processor and associated devices such as a coil, coil cable, external magnet, remote control, batteries, and battery holder.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09008737383015	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P000025	000