AccessGUDID - DEVICE: Neptune™ Covers (00840094451438)

GUDID

Device Identifier (DI) Information

Brand Name: Neptune™ Covers
Version or Model: CI-7126-BLK
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Advanced Bionics, LLC

Primary DI Number: 00840094451438
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 803906382 *Terms of Use
Previous DI: 07630016811401

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?
61242	Cochlear implant/auditory brainstem implant coil cover/spacer	A small device intended to be used as a cover/cap for the coil of a cochlear implant (CI) or auditory brainstem implant system, and/or to maintain the position of the coil casing. It is typically supplied with a removal tool. 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 [?]
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
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3df27891-3b9c-4477-a1cc-aee8215b93f5
Public Version Date: December 19, 2022
Public Version Number: 1
DI Record Publish Date: December 09, 2022