D Coil Base Part beige

Basic Information

• Brand Name: D Coil Base Part beige
• Primary DI: 09008737061609
• Version / Model: 06160
• 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: 2014-09-22
• Public Version: 6
• Public Version Date: 2022-09-15
• Public Version Status: Update
• Public Device Record Key: 675cb64d-5529-4d1a-b64f-0547bc98b2e7

Device Description

Audio Processor Coil Base

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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	09008737061609	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P000025	050
P000025	051
P000025	052
P000025	059
P000025	104

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 50 – 113 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 10 – 45 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 millibar
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 millibar