AccessGUDID - DEVICE: Nucleus (09321502006637)

GUDID

Device Identifier (DI) Information

Brand Name: Nucleus
Version or Model: Z60033
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z60033
Company Name: COCHLEAR LIMITED

Primary DI Number: 09321502006637
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 750551194 *Terms of Use

Device Description: CRYSTAL INTEGRITY TEST SYSTEM

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?
58794	Hearing implant implantable-component tester, postoperative	A portable electronic device designed to perform an integrity test on the implantable portion of a hearing implant [e.g., cochlear implant (CI)] system in situ postoperatively (e.g., during routine checks); the test is intended to provide objective data on implant function and aid in the assessment of implant failure/fault modes. It typically consists of hardware (e.g., biological signal amplifier, sound processor, coils, sign cables, magnets, leads) and software, and possibly includes consumables (e.g., skin electrodes/gel, swabs/wipes, tapes), to provide implant stimulation to the patient and acquire skin surface potential waveforms from the patient. 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	016

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 5 and 43 Degrees Celsius
Handling Environment Temperature: between 5 and 43 Degrees Celsius
Handling Environment Humidity: between 8 and 95 Percent (%) Relative Humidity
Storage Environment Humidity: between 8 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 931b1e08-bf31-4045-9633-b17f1644fafb
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: Yes
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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