AccessGUDID - DEVICE: Nucleus (09321502011532)

GUDID

Device Identifier (DI) Information

Brand Name: Nucleus
Version or Model: Z61019
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z61019
Company Name: COCHLEAR LIMITED

Primary DI Number: 09321502011532
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 750551194 *Terms of Use

Device Description: SP12 COIL SPACER, 3MM

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?
61242	Cochlear implant/auditory brainstem implant coil cover/spacer	A small device intended to be used as a cover/cap for the coil of a cochlear implant (CI) or auditory brainstem implant system, and/or to maintain the position of the coil casing. It is typically supplied with a removal tool. 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	028

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 -20 and 50 Degrees Celsius
Handling Environment Temperature: between -20 and 50 Degrees Celsius
Handling Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Width: 3 Millimeter
Device Size Text, specify: 3 mm wide spacer

Device Record Status

Public Device Record Key: 03394316-66ee-4f82-a12f-88339f2eb1cc
Public Version Date: April 08, 2022
Public Version Number: 4
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: No Unit of Use DI Numbers Found 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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