AccessGUDID - DEVICE: Cochlear ™ Nucleus® ABI541 Auditory Brainstem Implant (09321502020404)

GUDID

Device Identifier (DI) Information

Brand Name: Cochlear ™ Nucleus® ABI541 Auditory Brainstem Implant
Version or Model: Z246604
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z246604
Company Name: COCHLEAR LIMITED

Primary DI Number: 09321502020404
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 750551194 *Terms of Use

Device Description: N/A

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":	Yes
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?
47371	Auditory brainstem implant system electrode array assembly	The sterile implantable portion of an auditory brainstem implant system that typically consists of a battery-powered receiver-stimulator and an electrode array surgically placed on the brainstem's cochlear nucleus. The external portion of the device transmits electrical signals to the receiver-stimulator where they are decoded and sent to the multichannel electrode array to stimulate the brainstem's cochlear nucleus; this results in the signal's transmission to the brain where it is interpreted as sound.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MHE	Implant, auditory brainstem

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P000015	012

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
Special Storage Condition, Specify: Keep Dry
Handling Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Temperature: between -10 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fceea31c-a637-4595-9658-01b20dc430b7
Public Version Date: September 10, 2021
Public Version Number: 4
DI Record Publish Date: September 20, 2016