AccessGUDID - DEVICE: Cochlear™ Slimline™ Coil (5(I)) (09321502050371)

GUDID

Device Identifier (DI) Information

Brand Name: Cochlear™ Slimline™ Coil (5(I))
Version or Model: P1659646
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P1659646
Company Name: COCHLEAR LIMITED

Primary DI Number: 09321502050371
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 750551194 *Terms of Use

Device Description: 6cm (2 1/2") - Sand

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":	Yes
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	193

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 14 and 131 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6457c083-3375-496a-9404-b09bb7cc2670
Public Version Date: June 07, 2024
Public Version Number: 5
DI Record Publish Date: November 18, 2019