DIB II Coil i100

Basic Information

• Brand Name: DIB II Coil i100
• Primary DI: 09008737043766
• Version / Model: 04376
• Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
• Labeler DUNS: 300764032
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-22
• Public Version: 8
• Public Version Date: 2022-09-15
• Public Version Status: Update
• Public Device Record Key: 2e4232ed-214b-42ae-8ad2-11adb7f9ab52
• Distribution End Date: 2021-01-26

Device Description

Hardware Interface System Coil

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
58794	Hearing implant implantable-component tester, postoperative	A portable electronic device designed to perform an integrity test on the implantable portion of a hearing implant [e.g., cochlear implant (CI)] system in situ postoperatively (e.g., during routine checks); the test is intended to provide objective data on implant function and aid in the assessment of implant failure/fault modes. It typically consists of hardware (e.g., biological signal amplifier, sound processor, coils, sign cables, magnets, leads) and software, and possibly includes consumables (e.g., skin electrodes/gel, swabs/wipes, tapes), to provide implant stimulation to the patient and acquire skin surface potential waveforms from the patient. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09008737043766	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P000025	020
P000025	039
P000025	100

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -.4 – 113 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -18 – 45 Degrees Celsius