AccessGUDID - DEVICE: Cochlear™ Nucleus® 8 Processing Unit (09321502065221)

GUDID

Device Identifier (DI) Information

Brand Name: Cochlear™ Nucleus® 8 Processing Unit
Version or Model: P1840542
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P1840542
Company Name: COCHLEAR LIMITED

Primary DI Number: 09321502065221
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 750551194 *Terms of Use

Device Description: CP1110 Processing Unit, Grey

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	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?
47374	Cochlear implant/auditory brainstem implant sound processor	An external component of a cochlear implant (CI) or auditory brainstem implant system that typically consists of a battery-powered microphone/transmitter (transducer) designed to convert sound waves from the environment into electrical signals which are transmitted to the implantable portion of the system, via a coil (which may or may not be included), for the partial restoration of auditory sensation in a severely/profoundly deaf person. Also known as a speech processor, it is typically worn like a behind-the-ear (BTE) or off-the-ear (OTE) hearing aid.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCM	Implant, cochlear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P970051	211

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1da06105-3275-4fe8-a5c7-954ffa029aa7
Public Version Date: December 07, 2022
Public Version Number: 1
DI Record Publish Date: November 29, 2022