AccessGUDID - DEVICE: Nucleus (09321502027649)

GUDID

Device Identifier (DI) Information

Brand Name: Nucleus
Version or Model: FUZ061
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FUZ061
Company Name: COCHLEAR LIMITED

Primary DI Number: 09321502027649
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 750551194 *Terms of Use

Device Description: RETAINER DISK - 50 PACK

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?
67182	Hearing implant system external magnet, single-use	An external magnetic device intended to be adhered to the skin/scalp near the site of a cochlear implant, to hold an external component (e.g., sound processor, coil) in place through magnetic coupling. It is intended for use in patients without an implanted magnet (e.g., following magnet explantation). It is a magnetized metal disc contained within a polymer case that includes a pressure-sensitive adhesive on the patient-contact side. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCM	IMPLANT, COCHLEAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P970051	000

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: 473ab13b-9c9a-4589-ad24-b4402b067b57
Public Version Date: February 19, 2025
Public Version Number: 7
DI Record Publish Date: September 24, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 09321502032193 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)523-5798
Email: customer@cochlear.com

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