AccessGUDID - DEVICE: Nucleus CP800 Series Coil Magnet (09321502017220)

GUDID

Device Identifier (DI) Information

Brand Name: Nucleus CP800 Series Coil Magnet
Version or Model: Z218498
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: Z218498
Company Name: COCHLEAR LIMITED

Primary DI Number: 09321502017220
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 750551194 *Terms of Use

Device Description: Strength: 1/2 M Color: 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?
62944	Hearing implant system external magnet, reusable	A small, magnetic device intended to hold in place the sound processor and/or coil (not included) of a hearing implant system (e.g., cochlear, auditory brainstem, bone-conduction, partially-implantable middle ear implant system), to the outside of the scalp, typically by coupling with an implanted magnet. It is typically a magnetized metal disc that is attached to the processor/coil, but may be supplied separately. 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 [?]
P970051	049

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
Device Size Text, specify: 0.5 M strength magnet

Device Record Status

Public Device Record Key: 8a9e02e1-6e84-45d0-ba77-211579566294
Public Version Date: May 03, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2014