AccessGUDID - DEVICE: Neptune™ Cable for UHP (07630016811012)

GUDID

Device Identifier (DI) Information

Brand Name: Neptune™ Cable for UHP
Version or Model: CI-5413-505
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Advanced Bionics, LLC

Primary DI Number: 07630016811012
Issuing Agency: GS1
Commercial Distribution End Date: March 28, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 803906382 *Terms of Use

Device Description: White

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?
58186	Cochlear implant/auditory brainstem implant coil cable	An external component of a cochlear implant (CI) or auditory brainstem implant system that typically consists of a flexible and insulated electrical conductor with dedicated connectors designed to conduct electrical signals from the sound processor to the coil which are worn behind-the-ear (BTE); the sound processor and coil are not included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCM	IMPLANT, COCHLEAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P960058	089

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 Degrees Celsius
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 81 Centimeter

Device Record Status

Public Device Record Key: 2c83e578-92f3-4deb-b945-5b90db068bac
Public Version Date: March 28, 2024
Public Version Number: 5
DI Record Publish Date: October 16, 2015