AccessGUDID - DEVICE: Cochlear™ Hybrid™ Power Dome, 6 mm (09321502038485)

GUDID

Device Identifier (DI) Information

Brand Name: Cochlear™ Hybrid™ Power Dome, 6 mm
Version or Model: Z544997
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z544997
Company Name: COCHLEAR LIMITED

Primary DI Number: 09321502038485
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 750551194 *Terms of Use

Device Description: N/A

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	No
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?
62259	Earmould, preformed	A preformed device designed to fit in an ear canal and through which the acoustic output from a hearing aid is conveyed to the eardrum. It is made of soft synthetic polymer materials and may have various forms (e.g., plug-like, ear shape). 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	151

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
Outer Diameter: 6 Millimeter
Device Size Text, specify: 6mm diameter dome

Device Record Status

Public Device Record Key: a82cde22-939c-4e88-a307-b40094a56b35
Public Version Date: August 30, 2021
Public Version Number: 4
DI Record Publish Date: July 07, 2017