AccessGUDID - DEVICE: DIB II Coil (09008737041434)

GUDID

Device Identifier (DI) Information

Brand Name: DIB II Coil
Version or Model: 04143
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Primary DI Number: 09008737041434
Issuing Agency: GS1
Commercial Distribution End Date: January 26, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 300764032 *Terms of Use

Device Description: Hardware Interface System Coil

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCM	Implant, Cochlear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P000025	020
P000025	039
P000025	100

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8923d030-c08e-4adb-8fc9-358aab62328a
Public Version Date: May 19, 2022
Public Version Number: 7
DI Record Publish Date: September 22, 2014