AccessGUDID - DEVICE: HiRes™ Ultra 3D CI HiFocus™ MS Electrode (07630016877995)

GUDID

Device Identifier (DI) Information

Brand Name: HiRes™ Ultra 3D CI HiFocus™ MS Electrode
Version or Model: CI-1601-04
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Advanced Bionics AG

Primary DI Number: 07630016877995
Issuing Agency: GS1
Commercial Distribution End Date: March 14, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 485262658 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MCM	Implant, Cochlear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P960058	144

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 0 and 50 Degrees Celsius
Handling Environment Atmospheric Pressure: between 70 and 150 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 83be2162-42ca-4f0f-81cf-18d74a6fa1da
Public Version Date: March 15, 2024
Public Version Number: 6
DI Record Publish Date: January 21, 2020