AccessGUDID - DEVICE: Cochlear™ Nucleus® 8 Slimline™ Coil (5(I)) (09321502053600)

GUDID

Device Identifier (DI) Information

Brand Name: Cochlear™ Nucleus® 8 Slimline™ Coil (5(I))
Version or Model: P1749641
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P1749641
Company Name: COCHLEAR LIMITED

Primary DI Number: 09321502053600
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 750551194 *Terms of Use

Device Description: Black, 6cm (2 1/2")

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?
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 [?]
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
Length: 6 Centimeter
Device Size Text, specify: 6 cm long cable

Device Record Status

Public Device Record Key: ae8fc11d-4b98-4967-bbdf-d5a96550bea3
Public Version Date: December 07, 2022
Public Version Number: 1
DI Record Publish Date: November 29, 2022