AccessGUDID - DEVICE: UHP 2.0 Color Cap (07630016843105)

GUDID

Device Identifier (DI) Information

Brand Name: UHP 2.0 Color Cap
Version or Model: CI-7128-BLK
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Advanced Bionics AG

Primary DI Number: 07630016843105
Issuing Agency: GS1
Commercial Distribution End Date: March 18, 2024
Device Count: 2
Labeler D-U-N-S® Number*: 485262658 *Terms of Use

Device Description: Onyx

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	No
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCM	Implant, Cochlear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P960058	125

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
Storage Environment Temperature: between -20 and 55 Percent (%) Relative Humidity
Storage Environment Humidity: between 0 and 95 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2586b1d7-e622-4cc9-bb35-f3c505a30511
Public Version Date: March 19, 2024
Public Version Number: 6
DI Record Publish Date: May 14, 2018